To assess the effectiveness of an elective to improve students’ knowledge of fertility awareness-based methods for family planning and to determine whether there was a difference in knowledge gained by student type and/or course structure.
A quasi-experimental study of preand postassessment scores among three different groups of healthcare students. In one group, 24 undergraduate nursing students in a semester-long hybrid course. In a second group, 16 second year medical students in a six-week hybrid selective course. In the third group, 80 fourth year medical students in a two-week online elective for a total of 120 students completing the elective from January 2018 to June 2020. All students completed a knowledge assessment before the course, and the identical assessment after the course, with a maximum possible score of 20. ANOVA and non-parametric tests were used for data analysis.
The main outcome measure was comparison of post-course scores to pre-course scores. The mean pre-course score of about 50% in the undergraduate nursing group (x) was lower than the medical students in the six-week course (y) and two-week course (z) both about 70%. However, there was no difference in the mean post-course scores between the groups, which was about 90%. Assessments were mandated, but lectures were not, which could skew assessment scores. Additionally, the study focused on students signing up for the elective so it may not be generalizable to all medical and nursing student populations. Finally, educational interests and demographics impacting a student’s ability to learn and retain FABM knowledge is beyond the scope of this study. This elective was effective in improving fertility awareness-based method knowledge of medical and nursing students. All student groups had strong post-course knowledge scores – 90% accuracy, regardless of course structure. A fully online elective has the potential to make this knowledge easily available worldwide.
Fertility AwarenessWearable Temperature SensorsDevice ValidationTemperature-Based Methods
Open Access
Several studies have evaluated the reliability of using temperature sensors placed in different locations on the body to identify the day of ovulation. However, such demonstrations are lacking for axillary temperature wearable devices. This study aimed to evaluate the accuracy with which an axillary temperature armband sensor (Tempdrop) identifies the day of ovulation and the fertile window, using the Clearblue Connected Ovulation Test System as the reference method. A total of 194 cycles were analyzed from 125 women that participated in the study between April 2023 and June 2024. The performance the sensitivity (96.8% (95% CI 95.6; 97.7)), specificity (99.1% (98.8; 99.4)), accuracy (98.6% (98.2; 98.9)), positive predictive value (96.8% (95.6; 97.7)) and negative predictive value (99.1% (98.8; 99.4)). Furthermore, the results revealed a remarkably clear and better-than-expected change in temperature around the time of ovulation. This axillary temperature wearable sensor is an effective alternative to urine ovulation tests for determining the timing of ovulation. Another advantage is that it provides a clear temperature curve that can be used to evaluate the quality of the luteal phase.
Quantitative urine monitors are increasingly being used for a personalized approach to improve menstrual cycle knowledge and to manage fertility. Although several studies have evaluated urine fertility monitors in regular cycles, there is limited research in the use of quantitative monitors in reproductive disorders, such as polycystic ovarian syndrome (PCOS). Urine hormone data was collected with the Mira monitor from 20 participants, 10 of whom had PCOS and a matched group who had regular cycles. The main aim of this study was to evaluate the levels of luteinizing hormone (LH), estrone-3-glucuronide (E13G), and pregnanediol glucuronide (PDG) in PCOS menstrual cycles compared to regular cycles. Women with PCOS had higher BMI than regular cycling women (p=0.02). PCOS cycles were longer (p<0.05), peak day was later in the menstrual cycle (p<0.001), and luteal length was shorter (p < 0.01) compared to regular cycles. In whole cycle comparisons, E13G was found to be lower in PCOS cycles (p<0.01) and PDG was found to be higher in PCOS cycles (p<0.05). E13G was also lower in the follicular phase of and late luteal phase of PCOS cycles (p<0.00001). The results of this study demonstrate the feasibility of detecting hormonal differences in PCOS compared to regular cycles with at-home measurements with the Mira monitor. The metabolic dysregulation of PCOS is a possible factor in these hormone changes. Larger studies with different sub-types of PCOS will be needed to further clarify these changes and to understand the pathophysiology behind these hormonal changes.
Fertility AwarenessPopulation StudiesMisconceptionsReproductive Education
Open Access
Fertility rates in the UK are at an all-time low, with infertility affecting approximately 1 in 7 couples. Despite the rising demand for fertility services, fertility awareness, specifically knowledge of ovulation and the fertile window, remains low among women of reproductive age. Most existing studies offer a broad perspective, lacking focus on women actively trying to conceive (TTC). This study aims to assess the level of understanding surrounding the fertile window among women TTC, identifying factors associated with knowledge gaps. A retrospective, cross-sectional analysis of 97,414 women actively TTC who answered an online health assessment was conducted. Participants provided information on menstrual cycle characteristics, previous pregnancies, and fertility knowledge, including the timing of the fertile window. Frequencies, percentages were calculated and chi-squared tests performed to assess differences in categorical data. Logistic regression models were used to calculate odds ratios (ORs) to better understand factors significantly associated with not knowing the fertile window. Out of the total respondents (97,414), over a third (33,756, 41%) could not accurately identify the fertile window, with substantial misconceptions observed across all age groups and ethnicities. Women with previous pregnancies were more likely to correctly identify the fertile window (OR = 1.45, 97.5% CI: 1.20-1.75, p < 0.001). However, knowledge was significantly lower among those with irregular cycles, non-White ethnicities, younger age groups and longer time TTC. Additionally, misconceptions about cycle regularity were apparent, of 60,322 women describing their cycles as regular 10% did not know their cycle length (66,95) and a further 2.9% fell outside of the clinically regular 21-35 day range. These misconceptions followed a similar trend with younger age groups, non-white ethnicities and longer time TTC having significantly increased rates of misidentifying regular cycles. This further increased the odds of not knowing their fertile window (OR = 2.99, 97.5% CI: 2.83-3.17, p < 0.001). The findings reveal gaps in fertility awareness among women actively TTC. Addressing these knowledge gaps through targeted educational interventions could potentially reduce time-to-pregnancy and the reliance on assisted reproductive technologies. Improved fertility education focusing on cycle tracking and ovulation timing is essential to assist women with accurate information during their TTC journey.
Menstrual CycleSelf-Worth and MoodBasal Body TemperatureProspective Ovulation Cohort
Open Access
Knowledge of the fertile and infertile phases of the menstrual cycle can be applied to conceive or to avoid pregnancy. Fertility intentions and sexual behaviors during the fertile time may influence whether and when pregnancy occurs. The Creighton Model FertilityCare System (CrMS) is a specific system of fertility appreciation used to conceive or to avoid pregnancy. The objective of this paper is to report intentions, behaviors, and pregnancy rates during use of the CrMS among couples who initially intended to avoid pregnancy.Data and methodsWe analyzed a prospective cohort study conducted in 17 CrMS centers across the USA and Canada, following 296 couples for up to one year after onset of initial use of the CrMS to avoid pregnancy. Baseline data included demographics, motivations, and pregnancy intentions for each partner. Couples contributed 2894 menstrual cycles, most of which had data collected (by questionnaires and daily diary) on cycle-specific pregnancy intentions, days of potential fertility, and fertility behaviors. Pregnancies were prospectively actively ascertained. We found a high concordance (91%) in cycle pregnancy intentions between partners. However, 44% of cycles with strong intentions to avoid pregnancy included intercourse on potentially fertile days or days of undetermined fertility status. Across all sensitivity scenarios, cumulative 13-cycle pregnancy rates with cycle intention to conceive ranged from 88.0% to 89.8%, and cumulative 13-cycle pregnancy rates with cycle intention to avoid ranged from 29.1% to 35.3%. In multivariate analysis, baseline motivations and intentions for pregnancy within 2 years were strongly correlated with the likelihood of pregnancy, more so than cycle intentions. The findings suggest that in some populations using natural family planning, baseline motivations and intentions may be more strongly related to pregnancy rates than cycle intentions. Our findings also highlight essential elements for evaluating correct use, including complete recording of intercourse and its timing.
Fertility AwarenessEvidence ReviewHormone Monitoring and AppsPostpartum and Perimenopause
A one-day meeting was held as a pre-conference to the Catholic Medical Association Annual Educational event in 2024. A panel of eighteen physicians, scientists, and researchers involved in NFP work was convened to review the available (i) evidence for effectiveness of NFP methods to postpone and achieve pregnancy, (ii) evidence for effectiveness in the postpartum and perimenopause transition periods, (iii) evaluate the current state of technology in NFP (specifically app and quantitative hormone monitoring), and (iv) evidence examining the impact of NFP on marital relations. In each topical area, the panel worked to reach a consensus opinion on the currently available evidence and identified priorities for further research. Results from these discussions and a set of priorities for further work are presented here.
An expert panel was convened to review the current evidence supporting use of NFP in various settings, utilization of new technology, and the impact of NFP on marital dynamics. Results from these discussions and a set of priorities for further work are presented here.
Fertility AwarenessResidency TrainingPhysician KnowledgeClinical Education
Open Access
Damba-Cunningham E et al., 2025·J Restorative Reprod Med
Fertility awareness-based methods (FABM) of family planning have increased in popularity in recent years. The effectiveness of various methods can vary substantially and can be user dependent. For various reasons, there is a bias in OBGYN physicians against the use of FABMs for family planning. However, once educated about the methods of FABMs, this bias improves. There is limited regarding the education dedicated to FABM use in residency. We hypothesized that the residency education obtained regarding FABMs would be insufficient in preparing resident OBGYNs in effectively counseling patients regarding FABMs. a 16-question survey was created via SurveyMonkey and was sent to all ACGME accredited OBGYN residency programs for distribution to current residents. The survey was administered from October 2023 to December 2023. 125 responses were collected. Less than 40% of residents received formal training in regards to FABMs. Respondents indicated they felt most comfortable describing the calendar method to patients (68% respondents agree or strongly agree when queried if they could describe the method). 79.5% of respondents could not describe mucus-only, hormone monitoring, or sympto-thermal methods of family planning. When questioned if they were prepared to counsel postpartum patients who refused contraception regarding FABM, 58% of respondents indicated they could not assist their patients. Despite increased use in recent years and multiple options for FABM use, resident education in the application and use of FABMs is lacking. Additionally, residents indicated they are most familiar with the least effective methods (calendar method) which would likely be a significant detriment to their patients.
Menstrual CycleBreast ChangesPhysical SymptomsCyclical Mastalgia
Open Access
There is considerable individual day-to-day variation within the menstrual cycle and between cycles in women. Average hormone curves inadequately describe the individual hormone patterns experienced by women. The present study applies a novel application of a statistical array (heat map) to demonstrate both individual and group menstrual cycle hormone variability.
Using pre-existing datasets, two cohorts of women were analysed using a statistical method to visualise quantitative hormonal variation. In one cohort, 107 women contributed a total of 283 menstrual cycles and in the second cohort, 21 women contributed a total of 62 menstrual cycles. Women collected first morning urine samples for analysis of estrone-3-glucuronide (E1G) and luteinizing hormone (LH) in both datasets. In the larger dataset, pregnanediol-3-alpha-glucuronide (PDG) and follicle-stimulating hormone (FSH) were also collected. Serial ultrasounds identified the precise day of ovulation in the larger dataset. In the smaller dataset, peak LH was used to identify the estimated day of ovulation.
The main outcome measure was identifying hormonal variability using hormone array heat maps. Heat maps were able to quickly show clustering of hormone patterns in the fertile window and on the day of ovulation. Individual differences were identified in rows on the heat map relative to the day of ovulation. This new tool to visually represent hormonal changes with heat maps identifies both individual and group variability of menstrual cycle hormones.
NaProTECHNOLOGYFoundational PrinciplesClinical ApplicationRestorative Approaches
Open Access
In 1972, a seminal article was published demonstrating that women, adequately trained, could detect the approach of ovulation in the fertile window of their menstrual cycle. It was demonstrated that the symptoms perceived by women at the vulva correlate closely with changes in steroid hormone levels associated with folliculogenesis and the luteal phase. The fertility charting performed by women trained to recognize vulvar symptoms associated with hormonal changes serves as an instrument for detecting potential pathologies and monitoring the effects of treatment These findings established the biological foundations of a tool of fertility awareness tracking that has facilitated the development of restorative reproductive medicine (RRM): an approach that can be applied to identify and treat the underlying causes of infertility/subfertility.
Several core characteristics—or foundational pillars—of the RRM approach to fertility can be identified. a commitment to respecting healthy physiological processes, comprehensive health care for both the couple and the potential embryo, and the provision of education and continuous support throughout the therapeutic process.
This commentary aims to elucidate the interplay of these foundational pillars by drawing upon evidence from peer-reviewed biomedical literature. Finally, the challenges faced by RRM in strengthening its scientific foundations, engaging with the broader scientific community, and promoting the dissemination of this approach are described.
Fertility AwarenessUrinary Hormone MonitoringHormone ValidationHome Hormone Testing
Open Access
Bouchard TP et al., 2025·Womens Health Rep (New Rochelle)
Measuring quantitative menstrual cycle hormones at home may help women better understand their postpartum and perimenopause fertility transitions, but these quantitative fertility monitors require validation. This study included 16 North American women, aged 28-51, during either the postpartum (n = 8, cycles = 18) or perimenopause (n = 8, cycles = 35) fertility transitions testing daily first-morning urine testing with both the Mira Monitor and ClearBlue Fertility Monitor (CBFM) along with menstrual cycle parameter tracking. The main outcome measures were a rise in estrone-3-glucuronide (E13G) and luteinizing hormone (LH) urine hormone values from the Mira monitor correlated to low, high, or peak values on the CBFM. Both in the postpartum and perimenopause transitions, the identification of the day of ovulation based on the LH surge on the Mira and CBFM monitors was highly correlated (R = 0.94 and 0.83, p < 0.001). The E13G levels on the Mira monitor were significantly higher for a CBFM reading of "High" compared with "Low" for both the postpartum and perimenopausal cycles (all p < 0.001). Similarly, the LH levels on the Mira monitor were significantly higher for a CBFM reading of "Peak" (LH surge) compared with "High" for both the postpartum and perimenopausal cycles (all p < 0.001). The LH surge and levels of E13G in urine identified on the quantitative Mira fertility monitor strongly correlate to the LH surge and the shift from low to high on the CBFM during the postpartum and perimenopause transitions.
NaProTECHNOLOGYRestorative Reproductive Medicine OverviewDefinition and FrameworkBiomarker-Based Medical Evaluation
Open Access
Welcome to the Journal of Restorative Reproductive Medicine, the official journal of the International Institute for Restorative Reproductive Medicine! JRRM is a peer-reviewed, open-access medical journal for clinicians, scientists, professionals, and patients. Our vision is that JRRM will disseminate and promote evidence-based information to support and restore human fertility and reproductive health. Restorative reproductive medicine can be defined as approaches to systematically identify and treat underlying health conditions contributing to reproductive dysfunction and suboptimal reproductive health.1,2 In the case of subfertility, the aim is to restore the ability to have a healthy live birth, starting with natural intercourse in the fertile window.3 Consistent with this, JRRM approaches subfertility and recurrent miscarriage as related chronic conditions with many possible underlying contributors, including medical conditions, lifestyle, and environmental factors. The same framework applies to other conditions affected by or affecting human reproductive health, which is intertwined with somatic health.4-6 JRRM is particularly interested in articles from clinical medicine, physiology, epidemiology, data science, social sciences, and public health. Relevant clinical domains include, but are not limited to gynecology, andrology, endocrinology, infertility, midwifery, primary care, fertility cycle tracking. Occasionally, basic science or animal studies might be considered for publication, if they directly relate to the vision of JRRM. Articles not considered relevant to this journal include those focusing on the humanities or medical ethics, or research that does not focus on a restorative approach to human fertility and reproductive health. JRRM builds on a long history of tracking ovulation and the fertile window with fertility biomarkers, originally with the aim of natural regulation of fertility.7-10 In the past few decades, clinicians and investigators have explored the power and potential of applying these tools to medical evaluation and treatment.11-13 JRRM seeks to highlight and accelerate the development of scientific evidence linking fertility biomarkers and health. There are a growing number of high-quality journals related to human reproduction. JRRM focuses uniquely on restorative approaches to investigation and treatment, which often get less attention. There is a wide variety of motivations for the interest and engagement of patients and professionals in restorative preferences for less invasive natural approaches, commitments to patient empowerment, seeking answers for what is wrong, concerns about access and quality, reducing costs, and ethical and religious commitments.14-16 We all can benefit from a diversity of perspectives in the service of patients.17 All motivations are welcome at JRRM, as we focus together on a restorative approach to fertility and reproductive health
InfertilityPreconception HealthResearch AgendaHealth Optimization
Open Access
What is the relative length variance of the luteal phase compared to the follicular phase within healthy, non-smoking, normal-weight, proven normally ovulatory, premenopausal women with normal-length menstrual cycles? Prospective 1-year data from 53 premenopausal women with two proven normal-length (21-36 days) and normally ovulatory (≥10 days luteal) menstrual cycles upon enrollment showed that, despite 29% of all cycles having incident ovulatory disturbances, within-woman follicular phase length variances were significantly greater than luteal phase length variances. Many studies report menstrual cycle variability, yet few describe variability in follicular and luteal phase lengths. Luteal lengths are assumed 'fixed' at 13-14 days. Most studies have described follicular and luteal phase variability between-women. STUDY DESIGN, SIZE, This study was a prospective, 1-year, observational cohort study of relative follicular and luteal phase variability both between and within community-dwelling women with two documented normal-length (21-36 days) and normally ovulatory (≥10 days luteal phase) menstrual cycles prior to enrollment. Eighty-one women enrolled in the study and 66 women completed the 1-year study. This study analyzed data from 53 women with complete data for ≥8 cycles (mean 13). PARTICIPANTS/MATERIALS, SETTING, Participants were healthy, non-smoking, of normal BMI, ages 21-41 with two documented normal-length (21-36 days) and normally ovulatory (≥10 days luteal phase) menstrual cycles prior to enrollment. Participants recorded first morning temperature, exercise durations, and menstrual cycle/life experiences daily in the Menstrual Cycle Diary. We analyzed 694 cycles utilizing a twice-validated least-squares Quantitative Basal Temperature method to determine follicular and luteal phase lengths. Statistical analysis compared relative follicular and luteal phase variance in ovulatory cycles both between-women and within-woman. Normal-length cycles with short luteal phases or anovulation were considered to have subclinical ovulatory disturbances (SOD). Main The 1-year overall 53-woman, 676 ovulatory cycle variances for menstrual cycle, follicular, and luteal phase lengths were 10.3, 11.2, and 4.3 days, respectively. Median variances within-woman for cycle, follicular, and luteal lengths were 3.1, 5.2, and 3.0 days, respectively. Menstrual cycles were largely of normal lengths (98%) with 55% of women experienced >1 short luteal phase (<10 days) and 17% experienced at least one anovulatory cycle. Within-woman follicular phase length variances were greater than luteal phase length variances (P < 0.001). However, follicular (P = 0.008) and luteal phase length (P = 0.001) variances, without differences in cycle lengths, were greater in women experiencing any anovulatory cycles (n = 8) than in women with entirely normally ovulatory cycles (n = 6). LIMITATIONS, Limitations of this study include the relatively small cohort, that most women were White, initially had a normal BMI, and the original cohort required two normal-length and normally ovulatory menstrual cycles before enrollment. Thus, this cohort's data underestimated population menstrual cycle phase variances and the prevalence of SOD. Our results reinforce previous findings that the follicular phase is more variable than the luteal phase in premenopausal women with normal-length and ovulatory menstrual cycles. However, our study adds to the growing body of evidence that the luteal phase is not predictably 13-14 days long. STUDY FUNDING/COMPETING INTEREST(S): This medical education project of the University of British Columbia was funded by donations to the Centre for Menstrual Cycle and Ovulation Research. The authors do not have any conflicts of interest to disclose. N/A.
Fertility AwarenessEffectiveness for ConceptionMultiple Indicator ComparisonPreconception Danish
Open Access
Pedersen ES et al., 2024·Paediatr Perinat Epidemiol
The use of fertility indicators to predict ovulation has largely been studied for contraceptive purposes, while less so as fertility-promoting tools. To investigate the association between fertility indicators and fecundability in Danish women trying to conceive. Web-based preconception cohort study. We analysed data from 11,328 females aged 18-49 years trying to conceive without fertility treatment for ≤6 menstrual cycles, from the Danish SnartGravid.dk and SnartForældre.dk cohorts (2007-2023). Participants reported the use of fertility indicators (counting days since the last menstrual period, cervical fluid monitoring, urinary ovulation testing, feeling ovulation, using a smartphone fertility app and measuring basal body temperature [BBT]). Time to pregnancy was measured in menstrual cycles ascertained by self-reported pregnancy status. We estimated fecundability ratios (FR) and 95% confidence intervals (CI) using proportional probabilities regression models adjusted for age, socio-economic position, health indicators, reproductive history and gynaecological factors. Fertility indicators were used by 63.3% of participants at study entry. Counting days was the most common (46.9%), while measuring BBT was the least (3.0%). Other indicators ranged from 17.0% to 23.6%, with 69.7% using more than one indicator. Compared with non-use, use of any fertility indicator was associated with greater fecundability (adjusted FR 1.14, 95% CI 1.08, 1.19). Cervical fluid monitoring showed the strongest association (aFR 1.46, 95% CI 1.03, 2.07), followed by urinary ovulation testing (aFR 1.35, 95% CI 1.16, 1.58) and counting days (aFR 1.18, 95% CI 1.09, 1.29). Feeling ovulation and fertility apps were modestly associated with fecundability, while measuring BBT was not associated. Sensitivity analysis restricting to ≤2 cycles of attempt time and two cycles of follow-up showed an aFR for any indicator use of 1.21 (95% CI 1.13, 1.31). In this Danish preconception cohort, use of fertility indicators was associated with a higher fecundability, varying by type of indicator.
Fertility awareness-based methods (FABMs), also known as natural family planning (NFP), enable couples to identify the days of the menstrual cycle when intercourse may result in pregnancy ("fertile days"), and to avoid intercourse on fertile days if they wish to avoid pregnancy. Thus, these methods are fully dependent on user behavior for effectiveness to avoid pregnancy. For couples and clinicians considering the use of an FABM, one important metric to consider is the highest expected effectiveness (lowest possible pregnancy rate) during the correct use of the method to avoid pregnancy. To assess this, most studies of FABMs have reported a method-related pregnancy rate (a cumulative proportion), which is calculated based on all cycles (or months) in the study. In contrast, the correct use to avoid pregnancy rate (also a cumulative proportion) has the denominator of cycles with the correct use of the FABM to avoid pregnancy. The relationship between these measures has not been evaluated quantitatively. We conducted a series of simulations demonstrating that the method-related pregnancy rate is artificially decreased in direct proportion to the proportion of cycles with intermediate use (any use other than correct use to avoid or targeted use to conceive), which also increases the total pregnancy rate. Thus, as the total pregnancy rate rises (related to intermediate use), the method-related pregnancy rate falls artificially while the correct use pregnancy rate remains constant. For practical application, we propose the core elements needed to assess correct use cycles in FABM studies.
Fertility awareness-based methods (FABMs) can be used by couples to avoid pregnancy, by avoiding intercourse on fertile days. Users want to know what the highest effectiveness (lowest pregnancy rate) would be if they use an FABM correctly and consistently to avoid pregnancy. In this simulation study, we (1) the method-related pregnancy rate; and (2) the correct use pregnancy rate. We show that the method-related pregnancy rate is biased too low if some users in the study are not using the method consistently to avoid pregnancy, while the correct use pregnancy rate obtains an accurate estimate. In FABM studies, the method-related pregnancy rate is biased too low, but the correct use pregnancy rate is unbiased.
Fertility AwarenessMedical TrainingCurriculum DevelopmentFABM Knowledge
Open Access
Fertility awareness-based methods (FABMs) are evidence-based means of tracking observable biomarkers of a woman's fertility for the purpose of reproductive health monitoring and family planning. However, medical education regarding FABMs is limited. The purpose of this study was to examine the effect of a 4-week, two-part online elective on students' knowledge of FABMs, confidence in explaining and offering them to patients, and anticipated behaviors in future practice. The online elective, "FABMs for Family Planning and Women's Health," was delivered from August 2020 to May 2023. Students completed preand postknowledge surveys. Paired t tests and the Wilcoxon signed rank test were used for analysis of the data. A total of 571 students completed the elective, and 462 students completed both preand posttest surveys (response rate=81%). Students' knowledge of FABMs increased significantly. Posttest scores increased by a mean of 9.02 for Part A and 5.95 for Part B. We identified a significant increase in students' confidence discussing FABMs to avoid pregnancy, achieve pregnancy, monitor reproductive health, and address reproductive health concerns. At the completion of the elective, students were significantly more likely to offer FABMs as an option for most or all women. This online elective addresses the knowledge gap in FABMs and was effective in improving students' knowledge of FABMs and their confidence and willingness to offer these methods to patients for family planning and management of common women's health conditions.
Menstrual CycleCircaseptan and Circalunar RhythmsMenstrual Onset TimingLarge Population Analysis
Open Access
To study whether the menstrual cycle has a circaseptan (7 days) rhythm and whether it is associated with the lunar cycle (also defined as the synodic month, it is the cycle of the phases of the Moon as seen from Earth, averaging 29.5 days in length).
Cross-sectional study. A total of 35,940 European and North American women aged 18-40 years. Data were collected in real-life conditions. No intervention was performed. The onset of menstruation was assessed in prospectively measured menstrual cycles (311,064 cycles) over 3 full years (2019-2021). Associations were calculated between the onset of menstruation and the day of the week, and between the onset of menstruation and the lunar phase. In this large data set, a circaseptan (7-day) rhythmicity of menstruation was observed, with a peak (acrophase) of menstrual onset on Thursdays and Fridays. This circaseptan rhythm was observed in every age group, in every phase of the lunar cycle, and in all seasons. This feature was most pronounced for cycle durations between 27 and 29 days. In winter, the circaseptan rhythm was found in cycles of 27-29 days, but not in other cycle lengths. A circalunar rhythm was also statistically significant, but not as clearly defined as the circaseptan rhythm. The peak (acrophase) of the circalunar rhythm of menstrual onset varied according to the season. In addition, there was a small but statistically significant interaction between the circaseptan rhythm and the lunar cycle. Although relatively small in amplitude, the weekly rhythm of menstruation was statistically significant. Menstruation occurs more often on Thursdays and Fridays than on other days of the week. This is particularly true for women whose cycles last between 27 and 29 days. Circalunar rhythmicity was also statistically significant. However, it is less pronounced than the weekly rhythm.
Perimenopause/MenopauseHormone TrackingUrinary Hormone MonitoringPerimenopause
Open Access
The fertility tracking of menstrual cycles during perimenopause with a quantitative hormone monitor is a novel undertaking. Women in regular menstrual cycles have been tracking their fertility using different biomarkers since the 1960's. Presently, there are newer electronic hormonal devices used to track fertility that provide more exact and objective data to help delineate the fertile time frame of a woman's cycle. These devices measure quantitative levels of estrogen, the luteinizing hormone, progesterone, and follicle-stimulating hormone, all of which occur at varying levels during the menstrual cycle. As women advance toward menopause, their cycles vary in length, and their hormones fluctuate. In this retrospective analysis, forty-two women aged 40 to 50 tracked their cycles over time, and eight of these forty-two women used the quantitative hormonal device. With the use of this device, the perimenopausal period has revealed distinct hormonal cycle characteristics that are unique to this group of women. It is the purpose of this paper to discuss these cycle's characteristics during perimenopause, which were found with the use of the quantitative hormonal device.
To assess patient experiences using a Shared Decision-Making (SDM) Tool for fertility awareness-based methods (FABMs) of family planning. The study employed a prospective crossover design to evaluate impact of the SDM tool compared to usual practice when discussing FABMs with patients. Patients completed preand post-office visit surveys and an online survey six months later. The primary outcomes evaluated the effect of the SDM tool on patient satisfaction and FABM continuity of use rates. There was no significant difference in likelihood of changing family planning methods immediately after the office visit; however, by six months a significantly larger proportion of patients had started or changed FABMs in the experimental group (52%, 34/66) compared to the control group (36%, 24/66) (p = 0.04). Significantly more patients who used the tool and changed their FABM after their visit reported increased satisfaction with their FABM compared to control (50% vs. 17%, p = 0.022). Use of the SDM tool increased persistent use of and satisfaction with chosen FABMs at six months. The novel SDM tool can enhance patients' understanding and facilitate the selection of a more suitable method leading to increased satisfaction.
To assess the effect of randomization to FertilityFriend.com, a mobile computing fertility-tracking app, on fecundability.
Parallel non-blinded randomized controlled trial nested within the Pregnancy Study Online (PRESTO), a North American preconception cohort. PATIENT(S): Female participants aged 21 to 45 years attempting conception for ≤6 menstrual cycles at enrolment (2013-2019). Randomization (1:1) of 5532 participants to receive a premium Fertility Friend (FF) subscription. MAIN OUTCOME MEASURE(S): Fecundability (per-cycle probability of conception). Participants completed bimonthly follow-up questionnaires until pregnancy or a censoring event, whichever came first. We first performed an intent-to-treat analysis of the effect of FF randomization on fecundability. In secondary analyses, we used a per-protocol approach that accounted for adherence in each trial arm. In both analyses, we used proportional probabilities regression models to estimate fecundability ratios (FR) and 95% confidence intervals (CI) comparing those randomized vs. not randomized and applied inverse probability weights to account for loss-to-follow-up (intent-to-treat and per-protocol analyses) and adherence (per-protocol analyses only). Using life-table methods, 64% of the 2775 participants randomized to FF and 63% of the 2767 participants not randomized to FF conceived during 12 cycles; these respective percentages were each 70% among those with 0-1 cycles of attempt time at enrolment. Of those randomized to FF, 72% were defined as adherent (68% of observed menstrual cycles). In intent-to-treat analyses, there was no appreciable association overall (FR = 0.97; 95% CI, 0.90-1.04) or within strata of pregnancy attempt time at enrolment, age, education, or other characteristics. In per-protocol analyses, we observed little association overall (FR = 1.06; 95% CI, 0.99-1.14), but weak-to-moderate positive associations among participants who had longer attempt times at enrolment (FR = 1.15; 95% CI, 0.98-1.35 for 3-4 cycles; FR = 1.14; 95% CI, 0.87-1.48 for 5-6 cycles), were aged <25 years (FR = 1.29; 95% CI, 1.01-1.66), had ≤12 years of education (FR = 1.32; 95% CI, 0.92-1.89), or were non-users of hormonal contraception within 3 months before enrolment (FR = 1.10; 95% CI, 1.02-1.19). No appreciable associations were observed in intent-to-treat analyses. In secondary per-protocol analyses that accounted for adherence, randomization to FF was associated with slightly greater fecundability among selected subgroups of participants; however, these results are susceptible to unmeasured confounding.
To assess the impact of a Shared Decision-Making (SDM) tool for fertility awareness-based methods (FABMs) of family planning. Clinicians familiar with at least one FABM were randomly invited to participate in a prospective cross-over study to compare usual practice to the use of the SDM tool when discussing FABMs with patients. Patients completed surveys preand post-office visit and six months later. The primary outcome explored the effect of online education on use of the SDM tool on clinicians' knowledge of FABMs. Of 278 clinicians contacted, 54% could not be reached, and 15% did not provide women's health services. The 26 clinicians enrolled were experienced, with more than half recommending FABMs for ≥10 years, and 73% recommending more than one FABM to patients. Knowledge scores significantly improved after online training and use of the SDM tool (baseline mean score = 9.54 (scale of 0-12); post-training mean score = 10.73, p < 0.002). Education about FABMs and training on use of the SDM tool improved knowledge scores even among an experienced cohort of clinicians. The novel SDM tool can better equip clinicians to meet the rising patient interest in FABMs.
Evidence-based, nonbiased, counseling on contraceptive options, followed by shared decision-making, is key in facilitating reproductive justice in a diverse population. An estimated 3% of contraceptive users in the United States use fertility awareness-based methods (FABMs) for contraception, and demand for these methods is increasing. FABMs can be a highly effective form of family planning when used in accordance with evidence-based protocols. They are preferred by some patients due to medical contraindications to hormonal contraceptives, lack of side effects, religious convictions, preference to avoid hormones or contraceptive devices, improved body literacy, or a combination of the above. FABMs are infrequently covered in medical school curricula and are often perceived by physicians to be of low efficacy. There is an opportunity for improvement of physicians' evidence-based knowledge of FABMs, which has the potential to improve patient understanding of and access to the full menu of family planning options. A self-administered, cross-sectional survey was distributed to assess physician knowledge and opinions of FABMs by key university contacts. Univariate and bivariate statistics were calculated for close-ended questions and responses to open-ended questions were analyzed for common themes. A total of 79 participants completed the entire survey. Another 11 submitted partially completed surveys. For completed surveys, questions assessing knowledge of key concepts underlying FABMs, performance by specialty was 55% correct for OB/GYN (n = 16), 55% (n = 47) correct for family medicine, 36% (n = 10) correct for internal medicine, and 35% (n = 6) correct for pediatrics. Negative, neutral, mixed, and positive opinions related to FABMs were represented. There are opportunities to improve physicians' evidence-based knowledge of FABMs; this may improve patient-centered contraceptive care.
The uses of cervical mucus and basal body temperature as indicators of return to fertility postpartum have resulted in high unintended pregnancy rates. In 2013, a study found that when women used urine hormone signs in a postpartum/breastfeeding protocol this resulted in fewer pregnancies. To improve the original protocol's effectiveness, (1) women were to increase the number of days tested with the Clearblue Fertility Monitor, (2) an optional second luteinizing hormone test could be done in the evening, and (3) instructions were given to manage the beginning of the fertile window for the first six cycles postpartum. The purpose of this study was to determine the correct and typical use effectiveness rates to avoid pregnancy in women who used a revised postpartum/breastfeeding protocol. A cohort review of an established data set from 207 postpartum breastfeeding women who used the protocol to avoid pregnancy was completed using Kaplan-Meier survival analysis. Total pregnancy rates that included correct and incorrect use pregnancies were eighteen per one hundred women over twelve cycles of use. For the pregnancies that met a priori criteria, the correct use pregnancy rates were two per one hundred over twelve months and twelve cycles of use and typical use rates were four per one hundred women at twelve cycles of use. The protocol had fewer unplanned pregnancies than the original, however, the cost of the method increased.
This pilot qualitative case study was able to elicit rich data enabling a description of how women went through the journey of achieving pregnancy using fertility awareness-based methods. Findings underscore that women preferred using natural ways to detect ovulation and would recommend other women to do so, but with healthcare providers' guidance. The findings of this case study can serve as a starting point to provide a framework to understand women's experiences of enduring trial and error with multiple fertility awareness-based methods before discovering their effective method. Findings emphasize the importance for healthcare providers to guide women in using fertility awareness-based methods.
Accuracy in detecting ovulation and estimating the fertile window in the menstrual cycle is essential for women to avoid or achieve pregnancy. There has been a rapid growth in fertility apps and home ovulation testing kits in recent years. Nevertheless, there lacks information on how well these apps perform in helping users understand their fertility in the menstrual cycle. This pilot study aimed to evaluate and compare the beginning, peak, and length of the fertile window as determined by a new luteinizing hormone (LH) fertility tracking app with the Clearblue Fertility Monitor (CBFM). A total of 30 women were randomized into either a quantitative Premom or a qualitative Easy@Home (EAH) LH testing system. The results of the two testing systems were compared with the results from the CBFM over three menstrual cycles of use. Potential LH levels for estimating the beginning of the fertile window were calculated along with user acceptability and satisfaction. The estimates of peak fertility by the Premom and EAH LH testing were highly correlated with the CBFM peak results (R = 0.99, p < 0.001). The participants had higher satisfaction and ease-of-use ratings with the CBFM compared to the Premom and EAH LH testing systems. LH 95% confidence levels for estimating the beginning of the fertile window were provided for both the Premom and EAH LH testing results. Our pilot study findings suggest that the Premom and EAH LH fertility testing app can accurately detect impending ovulation for women and are easy to use at home. However, successful utilization of these low-cost LH testing tools and apps for fertility self-monitoring and family planning needs further evaluation with a large and more diverse population.
Body LiteracyMedical School CurriculaPhysician TrainingMedical Education Gaps
Knowledge and competency in the topics of reproductive health and family planning are important for primary care physicians. Given the high rates of unintended pregnancy, increasing rates of infertility and other gynecologic conditions, it is important for medical students, many of whom will become primary care physicians, to receive good foundational knowledge of reproductive health topics. The objective of this research project was to investigate the current curricula at US medical schools to determine the breadth and extent of education that medical students receive in reproductive health. Medical students and faculty at 20 US medical schools shared all relevant materials from their required reproductive health curriculum used between 2016-2019, including syllabi, PowerPoint lectures, and official class handouts that were available to all students. From these, the number of mentions of 69 reproductive health-related terms were counted, including those related to family planning methods, abortion, ectopic pregnancy, reproductive counseling, and infertility. Of the over 9000 mentions of reproductive health terms, approximately half of mentions were related to family planning, with 10% related to abortion, 10% to infertility, and 6% to reproductive counseling. Family planning strategies emphasized oral contraceptives and long-acting reversible contraceptives with limited mentions of natural or fertility awareness-based methods. This data demonstrates opportunities for broadening reproductive health education in medical school so that future primary care physicians are prepared to discuss the full range of reproductive options for their patients.
The timing of the resumption of post-partum menses is important for a woman who intends to avoid subsequent unintended pregnancy, and it has key implications on maternal, neonatal, and child health outcomes. Despite this, information is scant about the time to resumption of post-partum menses and predictors in Ethiopia. Therefore, this study aimed to determine the time it takes to start menses and spatial distribution among post-partum period women in Ethiopia and identify its predictors. A secondary data analysis was conducted based on 2016 Ethiopian Demographic and Health Survey (EDHS). A total weighted sample of 6,489 post-partum women was included in the analysis. STATA 14 was used to weigh, clean, and analyze the data. The shared frailty model was applied since the EDHS data have a hierarchical nature. For checking the proportional hazard assumption, the Schenefold residual test, Log-Log plot, Kaplan-Meier, and predicted survival plot were applied. Akakie Information Criteria (AIC), Cox-Snell residual test, and deviance were used for checking model adequacy and for model comparison. Based on these, the Gompertz inverse Gaussian shared frailty model was the best-fitted model for this data. Variables with a p < 0.2 were considered for the multivariable Gompertz inverse Gaussian shared frailty model. Finally, the adjusted hazard ratio (AHR) with a 95% confidence interval (CI), and a p < 0.05 was reported to identify the significant predictors of time to the resumption of post-partum menses. The median survival time to post-partum menses resumption was 14.6 months. In this study, 51.90% [95% CI: 50.03, 53.76] of post-partum period women had resumed, and the risk of menses resumption was 1.17 times [AHR: 1.17; 95% CI: 1.03-1.33] higher among urban resident, 1.14 times [AHR: 1.14; 95% CI: 1.0-1.24] in women who had attended formal education, and 1.63 times [AHR: 1.63; 95% CI: 1.4-1.7] higher among women who used hormonal contraceptives. However, the risk of post-partum menses resumption was lower among 7-24 months breastfeeding women by 36% [AHR: 0.64; 95% CI: 0.5-0.76], women with child alive by 26% [AHR: 0.74; 95% CI: 0.6-0.85], and multiparous women by 27% [AHR: 0.73; 95% CI: 0.6-0.80]. Almost half of the participants had resumed post-partum menses, with the median survival timing of menses resumption at 14.5 months. Women residing in urban areas, who attended formal education, and using hormonal contraceptives have a shorter time to resume post-partum menses, whereas a woman with an alive child, breastfeeding practice, and multiple parity has a longer time to resume post-partum menses. Therefore, the healthcare providers and program managers should act on the resumption of post-partum menses through health education and promotion to cultivate the 14 months lag period identified by considering the significant factors.
Does sexual intercourse enhance the cycle fecundability in women without known subfertility? Sexual intercourse (regardless of timing during the cycle) was associated with cycle characteristics suggesting higher fecundability, including longer luteal phase, less premenstrual spotting and more than 2 days of cervical fluid with estrogen-stimulated qualities. Human females are spontaneous ovulators, experiencing an LH surge and ovulation cyclically, independent of copulation. Natural conception requires intercourse to occur during the fertile window of a woman's menstrual cycle, i.e. the 6-day interval ending on the day of ovulation. However, most women with normal fecundity do not ovulate on Day 14, thus the timing of the hypothetical fertile window varies within and between women. This variability is influenced by age and parity and other known or unknown elements. While the impact of sexual intercourse around the time of implantation on the probability of achieving a pregnancy has been discussed by some researchers, there are limited data regarding how sexual intercourse may influence ovulation occurrence and menstrual cycle characteristics in humans. This study is a pooled analysis of three cohorts of women, enrolled at Creighton Model FertilityCare 'Creighton Model MultiCenter Fecundability Study' (CMFS: retrospective cohort, 1990-1996), 'Time to Pregnancy in Normal Fertility' (TTP: randomized trial, 2003-2006) and 'Creighton Model Effectiveness, Intentions, and Behaviors Assessment' (CEIBA: prospective cohort, 2009-2013). We evaluated cycle phase lengths, bleeding and cervical mucus patterns and estimated the fertile window in 2564 cycles of 530 women, followed for up to 1 year. Participants were US or Canadian women aged 18-40 and not pregnant, who were heterosexually active, without known subfertility and not taking exogenous hormones. Most of the women were intending to avoid pregnancy at the start of follow-up. Women recorded daily vaginal bleeding, mucus discharge and sexual intercourse using a standardized protocol and recording system for up to 1 year, yielding 2564 cycles available for analysis. The peak day of mucus discharge (generally the last day of cervical fluid with estrogen-stimulated qualities of being clear, stretchy or slippery) was used to identify the estimated day of ovulation, which we considered the last day of the follicular phase in ovulatory cycles. We used linear mixed models to assess continuous cycle parameters including cycle, menses and cycle phase lengths, and generalized linear models using Poisson regression with robust variance to assess dichotomous outcomes such as ovulatory function, short luteal phases and presence or absence of follicular or luteal bleeding. Cycles were stratified by the presence or absence of any sexual intercourse, while adjusting for women's parity, age, recent oral contraceptive use and breast feeding. MAIN Most women were <30 years of age (75.5%; median 27, interquartile range 24-29), non-Hispanic white (88.1%), with high socioeconomic indicators and nulliparous (70.9%). Cycles with no sexual intercourse compared to cycles with at least 1 day of sexual intercourse were shorter (29.1 days (95% CI 27.6, 30.7) versus 30.1 days (95% CI 28.7, 31.4)), had shorter luteal phases (10.8 days (95% CI 10.2, 11.5) versus 11.4 days (95% CI 10.9, 12.0)), had a higher probability of luteal phase deficiency (<10 days; adjusted probability ratio (PR) 1.31 (95% CI 1.00, 1.71)), had a higher probability of 2 days of premenstrual spotting (adjusted PR 2.15 (95% CI 1.09, 4.24)) and a higher probability of having two or fewer days of peak-type (estrogenic) cervical fluid (adjusted PR 1.49 (95% CI 1.03, 2.15)). LIMITATIONS Our study participants were geographically dispersed but relatively homogeneous in regard to race, ethnicity, income and educational levels, and all had male partners, which may limit the generalizability of the findings. We cannot exclude the possibility of undetected subfertility or related gynecologic disorders among some of the women, such as undetected endometriosis or polycystic ovary syndrome, which would impact the generalizability of our findings. Acute illness or stressful events might have reduced the likelihood of any intercourse during a cycle, while also altering cycle characteristics. Some cycles in the no intercourse group may have actually had undocumented intercourse or other sexual activity, but this would bias our results toward the null. The Creighton Model FertilityCare System (CrM) discourages use of barrier methods, so we believe that most instances of intercourse involved exposure to semen; however, condoms may have been used in some cycles. Our dataset lacks any information about the occurrence of female orgasm, precluding our ability to evaluate the independent or combined impact of female orgasm on cycle characteristics. Sexual activity may change reproductive hormonal patterns, and/or levels of reproductive hormones may influence the likelihood of sexual activity. Future work may help with understanding the extent to which exposure to seminal fluid, and/or female orgasm and/or timing of intercourse could impact menstrual cycle function. In theory, large data sets from women using menstrual and fertility tracking apps could be informative if women can be appropriately incentivized to record intercourse completely. It is also of interest to understand how cycle characteristics may differ in women with gynecological problems or subfertility. Funding for the research on the three cohorts analyzed in this study was provided by the Robert Wood Johnson Foundation #029258 (Creighton Model MultiCenter Fecundability Study), the Eunice Kennedy Shriver National Institute of Child Health and Human Development 1K23 HD0147901-01A1 (Time to Pregnancy in Normal Fertility) and the Office of Family Planning, Office of Population Affairs, Health and Human Services 1FPRPA006035 (Creighton Model Effectiveness, Intentions, and Behaviors Assessment). The authors declare that they have no conflict of interest. N/A.
Fertility AwarenessApp ComparisonFertile Window IdentificationBBT and Cervical Mucus
The Natural Cycles app employs daily basal body temperature to define the fertile window via a proprietary algorithm and is clinically established effective in preventing pregnancy. We sought to (1) compare the app-defined fertile window of Natural Cycles to that of CycleProGo, an app that uses BBT and cervical mucus to define the fertile window and (2) compare the app-defined fertile windows to the estimated physiologic fertile window. Daily BBT were entered into Natural Cycles from 20 randomly selected regularly cycling women with at least 12 complete cycles from the CycleProGo database. The proportion of cycles with equivalent (±1 cycle day) fertile-window starts and fertile-window ends was determined. The app-defined fertile windows were then compared to the estimated physiologic fertile window using Peak mucus to estimate ovulation. Fifty seven percent of cycles (136/238) had equivalent fertile-window starts and 36% (72/181) had equivalent fertile-window end days. The mean overall fertile-window length from Natural Cycles was 12.8 days compared to 15.1 days for CycleProGo (p < 0.001). The Natural Cycles algorithm declared 12% to 30% of cycles with a fertile-window start and 13% to 38% of cycles with a fertile-window end within the estimated physiologic fertile window. The CycleProGo algorithm declared 4% to 14% of cycles with a fertile-window start and no cycles with a fertile-window end within the estimated physiologic fertile window. Natural Cycles designated a higher proportion of cycles days as infertile within the estimated physiologic fertile window than CycleProGo.
Use of cervical mucus in addition to BBT may improve the accuracy of identifying the fertile window. Additional studies with other markers of ovulation and the fertile window would give additional insight into the clinical implications of app-defined fertile window differences.
Natural family planning (NFP) empowers women to control their reproductive health and approach fertility as a normal biological process. Although substantive literature supports their comparative effectiveness with contraceptive methods, there is a paucity of this knowledge amongst clinicians and users. This study aimed to understand clinicians' perceptions regarding offering NFP to patients as part of reproductive health care. It explored clinicians' knowledge of NFP, described their perceptions of their effectiveness, and identified enabling and deterring factors to their use. Basic Interpretive qualitative research design was appropriate in obtaining an in-depth description of this phenomenon. It was conducted in 2018 in two hospitals and clinics in Ekurhuleni health district, located East of Gauteng Province, South Africa. Fifteen doctors and nurses from diverse cultural and educational backgrounds were purposefully selected and interviewed. Transcribed data were analyzed, coded, and recurrent themes identified. Training that empowers clinicians on NFP methods and their effectiveness will improve their willingness to advocate for it and promote patient autonomy by providing comprehensive counseling on family planning methods. Further, a pro-NFP policy would drive training in undergraduate and postgraduate programs and increase public awareness, including early education of male and female children.
Bouchard TP et al., 2022·J Womens Health (Larchmt)
Some studies have suggested minor changes in the menstrual cycle after COVID-19 vaccination, but more detailed analyses of the menstrual cycle are needed to evaluate more specific changes in the menstrual cycle that are not affected by survey-based recall bias. Using a pretest-post-test quasi-experimental evaluation of menstrual cycle parameters before and after COVID-19 vaccination, we conducted an anonymous online survey of two groups of North American women who prospectively monitor their menstrual cycle parameters daily including bleeding patterns, urinary hormone levels using the ClearBlue Fertility Monitor, or cervical mucus observations. The primary outcome measures were cycle length, length of menses, menstrual volume, estimated day of ovulation (EDO), luteal phase length, and signs of ovulation. Perceived (subjective) menstrual cycle changes and stressors were also evaluated in this study as secondary outcome measures. Of the 279 women who initiated the survey, 76 met the inclusion criteria and provided 588 cycles for analysis (227 pre-vaccine cycles, 145 vaccine cycles, 216 post-vaccine cycles). Although 22% of women subjectively identified changes in their menstrual cycle, there were no significant differences in menstrual cycle parameters (cycle length, length of menses, EOD, and luteal phase length) between the pre-vaccine, vaccine, and post-vaccine cycles. COVID-19 vaccines were not associated with significant changes in menstrual cycle parameters. Perceived changes by an individual woman must be compared with statistical changes to avoid confirmation bias.
To summarize the evidence on typical and perfect-use effectiveness of fertility awareness-based methods for avoiding pregnancy during the postpartum period, whether breastfeeding or not. We conducted a systematic review of studies published in English, Spanish, French, or German by November 2021 in MEDLINE, EMBASE, CINAHL, Web of Science, and ClinicalTrials.gov. Abstract and full text reviews were completed by 2 independent reviewers. at least 50 subjects who enrolled prior to experiencing 3 cycles after childbirth and were using a specific fertility awareness-based method to avoid pregnancy; unintended pregnancy rate or probability calculated; postpartum amenorrheic and postpartum cycling individuals analyzed separately; and prospectively measured pregnancy intentions and outcomes. Outcomes were abstracted and study quality was systematically assessed by 2 independent investigators. Four studies provided effectiveness data for 1 specific fertility awareness-based method among postpartum individuals. Of these, there were zero high quality, 1 moderate quality, and 3 low quality for our question of interest. Typical-use pregnancy probability for the first 6 cycles postpartum for Marquette Method users was 12.0 per 100 women years (standard error [SE] not reported) and for Billings Ovulation Method users ranged from 9.1 (SE 3.9) for non-lactating women <30 years old to 26.8 (SE 4.6) for lactating women <30 years old. Typical-use pregnancy probabilities for the first 6 months post-first menses for the Postpartum Bridge to Standard Days Method users was 11.8 (95% confidence interval 6.01-17.16) and for Billings Ovulation Method users was 8.5 per 100 women (SE 1.7). The current evidence on the effectiveness of each fertility awareness-based method for postpartum persons is very limited and of mostly low quality. More high quality studies on the effectiveness of fertility awareness-based method in postpartum persons are needed to inform clinical counseling and patient-centered decision-making.
Although postpartum individuals may desire to use fertility awareness-based methods to avoid pregnancy, the evidence of the effectiveness of fertility awareness-based methods in this population is limited. More high-quality studies are needed to inform shared decision-making.
Fertility awareness-based methods (FABMs) educate about reproductive health and enable tracking and interpretation of physical signs, such as cervical fluid secretions and basal body temperature, which reflect the hormonal changes women experience on a cyclical basis during the years of ovarian activity. Some methods measure relevant hormone levels directly. Most FABMs allow women to identify ovulation and track this "vital sign" of the menstrual or female reproductive cycle, through daily observations recorded on cycle charts (paper or electronic). Physicians can use the information from FABM charts to guide the diagnosis and management of medical conditions and to support or restore healthy function of the reproductive and endocrine systems, using a restorative reproductive medical (RRM) approach. FABMs can also be used by couples to achieve or avoid pregnancy and may be most effective when taught by a trained instructor. Information about individual FABMs is rarely provided in medical education. Outdated information is widespread both in training programs and in the public sphere. Obtaining accurate information about FABMs is further complicated by the numerous period tracking or fertility apps available, because very few of these apps have evidence to support their effectiveness for identifying the fertile window, for achieving or preventing pregnancy. This article provides an overview of different types of FABMs with a published evidence base, apps and resources for learning and using FABMs, the role FABMs can play in medical evaluation and management, and the effectiveness of FABMs for family planning, both to achieve or to avoid pregnancy.
Over the last 5 decades, the fulfillment of maternity wishes in solid organ transplanted women has become a reality. Despite pregnancy contraindication in transplanted women during the early post-transplant period, such a condition can be overcome after 12 months if patients show a good clinical evolution and do not present other general pre-conceptional findings. This article presents the case report of a young female liver transplanted patient that used symptothermal method as a reliable family planning method. After her gestational contraindication was lifted, observation of biological fertility indicators and fertility-guided sexual intercourse helped her fulfill her maternity wish and conceive and carry out a healthy offspring. Based on this case and on the available bibliographic evidence, this paper reviews the potential implications of the use of this kind of approach as a safe and effective alternative to assisted reproduction technology in the management of potential infertility problems in the young female transplanted population, a population which according to literature has higher rates of unsuccessful parenthood and might also be more vulnerable to iatrogenicity of ovarian hyperstimulation process and to multiple pregnancy.
Caffeine is the most frequently used psychoactive substance in the United States and >90% of reproductive-age women report some amount of intake daily. Despite biological plausibility, previous studies on caffeine and fecundability report conflicting results. Importantly, prior studies measured caffeine exposure exclusively by self-report, which is subject to measurement error and does not account for factors that influence caffeine metabolism. Our objective was to examine associations between preconception serum caffeine metabolites, caffeinated beverage intake, and fecundability. Participants included 1228 women aged 18-40 y with a history of 1-2 pregnancy losses in the EAGeR (Effects of Aspirin in Gestation and Reproduction) trial. We prospectively evaluated associations of preconception caffeine metabolites (i.e., caffeine, paraxanthine, and theobromine) measured from 1191 serum samples untimed to a specific time of day, self-reported usual caffeinated beverage intakes at baseline, and time-varying cycle-average caffeinated beverage intake, with fecundability. Using Cox proportional hazards models, we estimated fecundability odds ratios (FORs) and 95% CIs according to each metabolite. Follow-up was complete for 89% (n = 1088) of participants. At baseline, 85%, 73%, and 91% of women had detectable serum caffeine, paraxanthine, and theobromine, respectively. A total of 797 women became pregnant during ≤6 cycles of preconception follow-up. After adjusting for potential confounders, neither serum caffeine [tertile (T)3 compared with T1 0.87; 95% CI: 0.71, 1.08], paraxanthine (T3 compared with T1 0.92; 95% CI: 0.75, 1.14), nor theobromine (T3 compared with T1 1.15; 95% CI: 0.95, 1.40) were associated with fecundability. Baseline intake of total caffeinated beverages was not associated with fecundability (>3 compared with 0 0.99; 95% CI: 0.74, 1.34), nor was caffeinated coffee (>2 compared with 0 0.93; 95% CI: 0.45, 1.92) or caffeinated soda (>2 0.92; 95% CI: 0.71, 1.20). Our findings are reassuring that caffeine exposure from usual low to moderate caffeinated beverage intake likely does not influence fecundability.This trial was registered at clinicaltrials.gov as NCT00467363.
Women of reproductive age need reliable and effective family planning methods to manage their fertility. Natural family planning (NFP) methods or fertility awareness-based methods (FABMs) have been increasingly used by women due to their health benefits. Nevertheless, effectiveness of these natural methods remains inconsistent, and these methods are difficult for healthcare providers to implement in their clinical practice. The purpose of this study is to evaluate the effectiveness of the Marquette Model NFP system to avoid pregnancy for women at multiple teaching sites using twelve months of retrospectively collected teaching data. Survival analysis (Kaplan-Meier) was used to determine typical unintended pregnancy rates for a total of 1,221 women. There were forty-two unintended pregnancies which provided a typical use unintended pregnancy rate of 6.7 per 100 women over twelve months of use. Eleven of the forty-two unintended pregnancies were associated with correct use of the method. The total unintended pregnancy rate over twelve months of use was 2.8 per 100 for women with regular cycles, 8.0 per 100 women for the postpartum and breastfeeding women, and 4.3 per 100 for women with irregular menstrual cycles. The Marquette Model system of NFP was effective when provided by health professionals who completed the Marquette Model NFP teacher training program.
This study involved determining whether healthcare professionals at ten sites across the United States and Canada trained to provide the Marquette Method NFP services can replicate the effectiveness demonstrated in previous studies of the method. We found a high level of effectiveness (i.e., very low pregnancy rates) in using the Marquette Method among women from various regions across North America with diverse reproductive backgrounds and in particular when using hormonal fertility marker. Healthcare providers who have been trained to teach NFP can successfully incorporate NFP services in their practice and assist their clients in choosing appropriate family planning methods.
NaProTECHNOLOGYBiophysical PropertiesCervical MucusFertile Window Detection
Open Access
The principal objective of this study was to correlate biophysical properties of vaginal discharge present in the cervical mucus with the timing of the fertile window. In particular, we produce measures of the viscoelasticity of the cervical secretion using two methods. The first uses only the elasticity extracted from the Creighton Model Fertility Care System (CrMs) scale, calculated P-6 ovulation estimated day (OED) with respect to the peak day of the CrMs. The second uses a numerical method that takes into account the changes in viscoelasticity, but without reference to the peak day calculated using the CrMs model. Using both methods, twelve records were obtained from a single female subject. The methodology used to evaluate the viscoelasticity factor was by measuring the approximate length in centimeters (cm) of the vaginal discharge of cervical discharge. For this, the scale of the stretching graph established by observing the stretching of CrMS was used, taking into account the previous 6 days at peak day P-6. The first method, which we termed CFW (Clinical Fertile Window), uses a measure based on the approximate length (cm) of the maximal stretchiness of the vaginal discharge. The second method we termed SFW (Software-CrMS/strectching) (Software-based Fertile Window). The fertile window was detected correctly in 100% of the cases using either method, and a correlation value of 0.71 was observed between the two methods. We conclude that the assessment of viscoelasticity using SFW algorithm allowed in this pilot study to detect the fertile window and to describe the evolution pattern of cervical discharge throughout the fertile window. Our study provides support for the use of computational methods in detecting the fertile window, taking only into account the time evolution of the cervical discharge throughout the menstrual cycle.
A new fertility monitor is now available that provides quantitative measurement of urinary hormones, but clinical use requires validation against an established fertility monitor that provides only qualitative results. Two fertility monitors were compared using daily first morning urine samples over 3 cycles of use in 21 women users with experience using a fertility monitor with the Marquette Method of Natural Family Planning. Women were aged 33.4 ± 5.5 years and had menstrual cycles ranging between 23 and 41 days. The quantitative Mira Monitor estimates of ovulation were highly correlated with the qualitative ClearBlue Fertility Monitor (CBFM) estimates of ovulation. Both monitors provided an accurate estimate of the fertile window. In this preliminary trial, the Mira monitor was shown to be effective at delineating the fertile window and ovulation. We demonstrated the feasibility of applying the Marquette Method algorithm with the use of the Mira monitor. Satisfaction differences between the two monitors did not reach statistical significance. We anticipate that quantitative fertility monitoring will give couples and health-care providers new and unprecedented insights into the menstrual cycle and fertility.
Time to pregnancy (TTP) is a biomarker of fecundability and has been associated with behavioral and environmental characteristics; however, these associations have not been examined in a large population-based sample of application (app) users. This observational study followed 5,376 women with an age range of 18 to 45 years who used an app to identify their fertile window. We included women who started trying to conceive between September 30, 2017 and August 31, 2018. TTP was calculated as the number of menstrual cycles from when the user switched to "Plan" mode up to and including the cycle in which they logged a positive pregnancy test. We examined associations with several characteristics, including age, gravidity, body mass index, cycle length and cycle length variation, frequency of sexual intercourse, and temperature measuring frequency. Discrete time fecundability models were used to estimate fecundability odds ratios. For the complete cohort the 6-cycle and 12-cycle cumulative pregnancy probabilities were found to be 61% (95% confidence interval [CI]: 59-62) and 74% (95% CI: 73-76), respectively. The median TTP was four cycles. The highest fecundability was associated with an age of less than 35 years, with cycle length variation <5 days and logging sexual intercourse on at least 20% of days added (the proportion of days in which intercourse was logged) (11.5% [n = 613] of entire sample). This group achieved a 6and 12-cycle cumulative pregnancy probability of 88% (95% CI: 85-91) and 95% (95% CI: 94-97), respectively, and a TTP of 2 cycles. Natural Cycles was an effective method of identifying the fertile window and a noninvasive educational option for women planning a pregnancy. Women under age 35 with regular cycles showed a high pregnancy rate.
What is the normal range of cervical mucus patterns and number of days with high or moderate day-specific probability of pregnancy (if intercourse occurs on a specific day) based on cervical mucus secretion, in women without known subfertility, and how are these patterns related to parity and age? The mean days of peak type (estrogenic) mucus per cycle was 6.4, the mean number of potentially fertile days was 12.1; parous versus nulliparous, and younger nulliparous (<30 years) versus older nulliparous women had more days of peak type mucus, and more potentially fertile days in each cycle. The rise in estrogen prior to ovulation supports the secretion of increasing quantity and estrogenic quality of cervical mucus, and the subsequent rise in progesterone after ovulation causes an abrupt decrease in mucus secretion. Cervical mucus secretion on each day correlates highly with the probability of pregnancy if intercourse occurs on that day, and overall cervical mucus quality for the cycle correlates with cycle fecundability. No prior studies have described parity and age jointly in relation to cervical mucus patterns. STUDY DESIGN, SIZE, This study is a secondary data analysis, combining data 'Creighton Model MultiCenter Fecundability Study' (CMFS: retrospective cohort, 1990-1996), 'Time to Pregnancy in Normal Fertility' (TTP: randomized trial, 2003-2006), and 'Creighton Model Effectiveness, Intentions, and Behaviors Assessment' (CEIBA: prospective cohort, 2009-2013). We evaluated cervical mucus patterns and estimated fertile window in 2488 ovulatory cycles of 528 women, followed for up to 1 year. PARTICIPANTS/MATERIALS, SETTING, Participants were US or Canadian women age 18-40 years, not pregnant, and without any known subfertility. Women were trained to use a standardized protocol (the Creighton Model) for daily vulvar observation, description, and recording of cervical mucus. The mucus peak day (the last day of estrogenic quality mucus) was used as the estimated day of ovulation. We conducted dichotomous stratified analyses for cervical mucus patterns by age, parity, race, recent oral contraceptive use (within 60 days), partial breast feeding, alcohol, and smoking. Focusing on the clinical characteristics most correlated to cervical mucus patterns, linear mixed models were used to assess continuous cervical mucus parameters and generalized linear models using Poisson regression with robust variance were used to assess dichotomous outcomes, stratifying by women's parity and age, while adjusting for recent oral contraceptive use and breast feeding. MAIN The majority of women were <30 years of age (75.4%) (median 27; IQR 24-29), non-Hispanic white (88.1%), with high socioeconomic indicators, and nulliparous (70.8%). The mean (SD) days of estrogenic (peak type) mucus per cycle (a conservative indicator of the fertile window) was 6.4 (4.2) days (median 6; IQR 4-8). The mean (SD) number of any potentially fertile days (a broader clinical indicator of the fertile window) was 12.1 (5.4) days (median 11; IQR 9-14). Taking into account recent oral contraceptive use and breastfeeding, nulliparous women age ≥30 years compared to nulliparous women age <30 years had fewer mean days of peak type mucus per cycle (5.3 versus 6.4 days, P = 0.02), and fewer potentially fertile days (11.8 versus 13.9 days, P < 0.01). Compared to nulliparous women age <30 years, the likelihood of cycles with peak type mucus ≤2 days, potentially fertile days ≤9, and cervical mucus cycle score (for estrogenic quality of mucus) ≤5.0 were significantly higher among nulliparous women age ≥30 years, 1.90 (95% confidence interval (CI) 1.18, 3.06); 1.46 (95% CI 1.12, 1.91); and 1.45 (95% CI 1.03, 2.05), respectively. Between parous women, there was little difference in mucus parameters by age. Thresholds set a priori for within-woman variability of cervical mucus parameters by most minus fewest days of peak type mucus >3 days (exceeded by 72% of women), most minus fewest days of non-peak type mucus >4 days (exceeded by 54% of women), greatest minus least cervical mucus cycle score >4.0 (exceeded by 73% of women), and most minus fewest potentially fertile days >8 days (found in 50% of women). Race did not have any association with cervical mucus parameters. Recent oral contraceptive use was associated with reduced cervical mucus cycle score and partial breast feeding was associated with a higher number of days of mucus (both peak type and non-peak type), consistent with prior research. Among the women for whom data were available (CEIBA and TTP), alcohol and tobacco use had minimal impact on cervical mucus parameters. LIMITATIONS, We did not have data on some factors that may impact ovulation, hormone levels, and mucus secretion, such as physical activity and body mass index. We cannot exclude the possibility that some women had unknown subfertility or undiagnosed gynecologic disorders. Only 27 women were age 35 or older. Our study participants were geographically dispersed but relatively homogeneous with regard to race, ethnicity, income, and educational level, which may limit the generalizability of the findings. Patterns of cervical mucus secretion observed by women are an indicator of fecundity and the fertile window that are consistent with the known associations of age and parity with fecundity. The number of potentially fertile days (12 days) is likely greater than commonly assumed, while the number of days of highly estrogenic mucus (and higher probability of pregnancy) correlates with prior identifications of the fertile window (6 days). There may be substantial variability in fecundability between cycles for the same woman. Future work can use cervical mucus secretion as an indicator of fecundity and should investigate the distribution of similar cycle parameters in women with various reproductive or gynecologic pathologies. STUDY FUNDING/COMPETING INTEREST(S): Funding for the three cohorts analyzed was provided by the Robert Wood Johnson Foundation (CMFS), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (TTP), and the Office of Family Planning, Office of Population Affairs, Health and Human Services (CEIBA). The authors declare that they have no conflict of interest. N/A.
To synthesize the literature on fertility knowledge and fertility-awareness among women seeking pregnancy. The search terms "fertility-awareness OR fertility knowledge AND women AND subfertile OR infertile OR seeking pregnancy OR trying to conceive OR pre-conception OR conception NOT contraception NOT birth control" were used via CINAHL, PubMed, and Web of Science. Primary research studies were considered in the search parameters. Searches yielded 116 studies published between 1978 and 2020. After screening, 43 full-text studies were assessed for eligibility, 35 of which were omitted as not relevant. Nine quantitative studies using cross-sectional designs met this review's inclusion criteria. Studies were reviewed for information on the relationship between fertility knowledge/fertility-awareness and pregnancy intention. Studies examining the results of fertility-awareness based method (FABM) efficacy, FABMs for contraception, and provider knowledge regarding FABMs were omitted. Analysis showed low knowledge regarding the identification of the fertile window in the menstrual cycle to optimize pregnancy. There was moderate general knowledge on fertility (e.g., infertility definition, age of fertility decline, etc.). Use of an FABM and education regarding FABMs were infrequent, yet participants recognized that it would be beneficial to use and learn when trying to conceive. Women seeking pregnancy have low to moderate fertility knowledge. More research is necessary on the relationship between fertility knowledge/fertility-awareness and unexplained infertility. Nurses, nurse practitioners, and nurse-midwives should provide education on FABMs to women when they first report difficulty achieving pregnancy. Clinicians' approaches toward FABM education for women and how to implement FABM education into the preconception visit are important areas for future research.
The aim of this study was to determine predictive factors for pregnancy and assess the cumulative pregnancy rate (CPR) and live birth rate (CLBR) in subfertile couples undergoing timed intercourse (TI) using ultrasound. This retrospective cohort study included 285 women (854 cycles) who started TI with ultrasound between January 2017 and October 2019. The overall clinical pregnancy rate was 28.1% (80/285) per couple and 9.4% (80/854) per cycle. Pregnant women had a higher body mass index (BMI), higher percentage of irregular menstrual cycles, a shorter duration of subfertility, lower serum follicle-stimulating hormone levels, and higher anti-Müllerian hormone levels than non-pregnant women. A longer duration of subfertility (≥24 months vs. <12 months; 0.193; 95% 0.043-0.859) and endometriosis (vs. ovulatory factors; 0.282; 95% 0.106-0.746) as causes of subfertility were unfavorable factors that independently affected clinical pregnancy. In subgroup analysis, old age ≥ 35 years [vs. < 35 years; 0.279; 95% 0.083-0.938), a longer duration of infertility ≥24 months (vs. <24 months; 0.182; 95% 0.036-0.913) and a higher BMI ≥ 25 kg/m(2)(vs. >25 kg/m(2); 3.202; 95% 1.020-10.046) in couples with ovulatory factor and a longer duration of infertility ≥24 months (vs. <24 months; 0.185; 95% 0.042-0.819) in couples with non-ovulatory factors were significant independent predictive factors for pregnancy. No significant differences were found in the cycle characteristics between pregnant and non-pregnant women. The CPR substantially increased during the first three cycles and significantly increased until the sixth cycle. No significant increase was observed in the CPR after the sixth cycle. The CLBRs substantially increased during the first three cycles and significantly increased until the fourth cycle. No significant increase was observed in the CLBRs after the fifth cycle. When comparing CPRs and CLBRs according to subfertile causes, CRPs was significantly different and CLBRs was different with borderline significance. Our findings may indicate that women with a longer duration of subfertility or subfertility due to endometriosis have poor outcomes during TI with ultrasound. Women who failed to achieve conception by the fourth or fifth cycle of TI with ultrasound may be encouraged to consider advancing to the next treatment strategy.
Menstrual CycleHormonal Effects on BehaviorMid-Cycle Hormonal EffectsBasal Body Temperature Analysis
Allison B Macbeth et al., 2021·Women's Reproductive Health
Women's interest in sex is asserted to increase at the mid-cycle pre-ovulatory estradiol peak. We explored this belief in healthy, spontaneously normally menstruating/ovulating women. Women recorded "interest in sex" in a daily diary; validated Quantitative Basal Temperature analysis documented ovulation. Interest in sex showed no mid-cycle peak in 61 normal-weight, nonsmoking women, ages 33.7 ± 5.6 years, over a mean of 311 consecutive days. The cycle-plotted diary "self-worth" factor (including feelings of energy, interest in sex) also showed no mid-cycle peak. Thus, interest in sex is related more strongly to women's feelings/experiences than to hormones, challenging deterministic or sex-hormone-dependent cultural and sociobiological understandings.
Fertility is becoming increasingly supported by consumer health technologies, especially mobile apps that support self-tracking activities. However, it is not clear whether the apps support the variety of goals and life events of those who menstruate, especially during transitions between them. Thirty-one of the most popular fertility apps were evaluated, analyzing the content of app store pages, app features, and user reviews. Results suggest that fertility apps are designed to support specific life goals of people who menstruate, offering several data collection features and limited feedback options. However, users often desire holistic tracking that encompasses a variety of goals, life events, and the transitions among them. These findings suggest fertility patients can benefit more from holistic self-tracking and provide insights for future design of consumer health technologies that better support holistic fertility tracking. Fertility apps have the potential to support varied experiences of people who menstruate. But to achieve that, apps need to expand their support by offering ways for more users to perform holistic, personalized, and personally meaningful tracking, so they can derive long-term benefit from the data they collect.
Pearson JT et al., 2021·Eur J Contracept Reprod Health Care
Digital fertility awareness-based contraception offers an alternative choice for women who do not wish to use hormonal or invasive methods. The aim of this study was to investigate the key demographics of current users of the Natural Cycles app and assess the contraceptive outcomes of women preventing pregnancy in a UK cohort of women. This was a real world observational prospective observational study. The typical-use effectiveness of the method was calculated using both 13-cycle cumulative probability of pregnancy (life table analysis) and Pearl Index for the entire study cohort. Perfect-use PI was calculated using data from cycles where sexual intercourse during the fertile window was marked as protected and no unprotected sex was recorded on fertile days. 12,247 women were included in the study and contributed an average of 9.9 months of data for a total of 10,066 woman years of exposure. The mean age of the cohort was 30, mean BMI 23.4, the majority were in a stable relationship (83.2%) and had a university degree or higher (83%). The one year typical use, PI was 6.1 (95% CI: 5.6, 6.6) and with perfect-use was 2.0 (95% CI: 1.3, 2.8). 13 cycle pregnancy probability was 7.1%. This is the first study which describes the use of a digital contraceptive by women in the UK. It describes the demographics of users and how they correlate with the apps effectiveness at preventing pregnancy.
Marital chastity is the practice of periodic abstinence with use of natural family planning (NFP). The purpose of this study was to determine the influence of the most common methods of contraception (female sterilization, oral contraceptive pills, and condoms) and NFP on divorce/separation and cohabitation rates among reproductive age women. The study involved an extensive review of the literature on the effects of practice of NFP on marital dynamics and a statistical analysis of 2,550 ever-married women in the (2015-2017) National Survey of Family Growth data set. Importance of religion and frequency of church attendance were included in the analysis. With ever-use of NFP, 14 percent were divorced or separated, and 27 percent to 39 percent were divorced or separated with ever-use of oral contraceptive pills. Stepwise logistic regression indicated that ever-use of contraception was associated with increased odds of divorce or separation (odds ratio [OR] = 2.05; confidence interval [CI]: 1.96-2.49) and cohabitation (2.95, CI: 2.20-3.95). Ever-use of NFP yielded 58 percent lower odds for divorce or separation. Frequent church attendance was associated with lower odds of divorce or separation and cohabitation. Although there are lower odds of divorce among NFP users, the reason might be due to their religiosity.
This study showed that ever-use of natural family planning (NFP) among ever-married women was associated with 58 percent lower odds of divorce than among women who never-used NFP. Ever-use of contraceptive methods was associated with two times the odds of divorce and four times for cohabitation compared to those women who never-used those methods. Use of periodic abstinence with NFP is the practice of marital chastity and is thought to strengthen the marital relationship.
Fertility AwarenessApp-Based MethodsFertility Awareness MethodsProspective Cohort Study
Digital fertility awareness-based methods of birth control are an attractive alternative to hormonal or invasive birth control for modern women. They are also popular among women who may be planning a pregnancy over the coming years and wish to learn about their individual menstrual cycle. The aim of this study was to assess the effectiveness of the Natural Cycles app at preventing pregnancy for a cohort of women from the United States and to describe the key demographics of current users of the app in such a cohort. This prospective real-world cohort study included users who purchased an annual subscription to prevent pregnancy. Demographics were assessed through answers to in-app questionnaires. Birth control effectiveness estimates for the entire cohort were calculated using 1-year pearl index (PI) and 13-cycle cumulative pregnancy probability (Kaplan-Meier life table analysis). The study included 5879 women who contributed an average of 10.5 months of data for a total of 5125 woman-years of exposure. The average user was 30 years old with a body mass index of 24 and reported being in a stable relationship. With typical use, the app had a 13-cycle cumulative pregnancy probability of 7.2% and a 1-year typical use PI of 6.2. When the app was used under perfect use, the PI was 2.0. The data presented in this study give insights into the cohort of women using this app in the United States, and provide country-specific effectiveness estimates. The contraceptive effectiveness of the app was in line with previously published figures from Natural Cycles (PI of seven for typical use and two for perfect use).
DeVilbiss EA et al., 2020·Paediatr Perinat Epidemiol
Attaining pregnancy is conditional upon a series of complex processes, including adequately timed intercourse, ovulation, fertilisation, and implantation. Anovulation is a first-line treatment target for couples with difficulty conceiving and is frequently examined in studies of fecundability. To identify whether sporadic anovulation is an important determinant of cumulative pregnancy rates and time to pregnancy among fertile women with regular menstrual cycles. We simulated cumulative pregnancy rates and time to pregnancy for 12 consecutive menstrual cycles among 100 000 women based on data-driven probabilities of implantation, fertilisation, ovulation, and intercourse occurring in the fertile window. We assumed anovulation probabilities of 1%, 8%, or 14.5% and intercourse averaging once per week, every other day, or daily. The model incorporated reductions in implantation and fertilisation rates for successive cycles of non-pregnancy. After 12 cycles, a reduction in the per cycle incidence of anovulation from 14.5% to 1% resulted in a 4.0% higher cumulative pregnancy rate (86.7% vs 90.7%) and similar time to pregnancy (1-cycle median difference). In contrast, increasing mean unscheduled sexual intercourse frequency from weekly to every other day was associated with a 5-cycle median reduction in time to pregnancy (weekly: 7 cycles; 2 cycles) and a 28.9% increase in the cumulative pregnancy rate (weekly: 59.9%, 88.8%; 91.6%). In presumed fertile women with regular menstrual cycles, routine investigation of anovulation may not be an informative outcome in studies of fecundability, and routine testing to ensure ovulation and treatment of anovulation are unlikely to be medically necessary. While biomarkers or cervical fluid may help time intercourse to the fertile window, time to pregnancy can also be improved through increasing the frequency of unscheduled intercourse. These findings need corroboration in large preconception time to pregnancy studies.
To what extent does the use of mobile computing apps to track the menstrual cycle and the fertile window influence fecundability among women trying to conceive? After adjusting for potential confounders, use of any of several different apps was associated with increased fecundability ranging from 12% to 20% per cycle of attempt. Many women are using mobile computing apps to track their menstrual cycle and the fertile window, including while trying to conceive. STUDY DESIGN, SIZE, The Pregnancy Study Online (PRESTO) is a North American prospective internet-based cohort of women who are aged 21-45 years, trying to conceive and not using contraception or fertility treatment at baseline. PARTICIPANTS/MATERIALS, SETTING, We restricted the analysis to 8363 women trying to conceive for no more than 6 months at baseline; the women were recruited from June 2013 through May 2019. Women completed questionnaires at baseline and every 2 months for up to 1 year. The main outcome was fecundability, i.e. the per-cycle probability of conception, which we assessed using self-reported data on time to pregnancy (confirmed by positive home pregnancy test) in menstrual cycles. On the baseline and follow-up questionnaires, women reported whether they used mobile computing apps to track their menstrual cycles ('cycle apps') and, if so, which one(s). We estimated fecundability ratios (FRs) for the use of cycle apps, adjusted for female age, race/ethnicity, prior pregnancy, BMI, income, current smoking, education, partner education, caffeine intake, use of hormonal contraceptives as the last method of contraception, hours of sleep per night, cycle regularity, use of prenatal supplements, marital status, intercourse frequency and history of subfertility. We also examined the impact of concurrent basal body temperature, cervical fluid, cervix position and/or urine LH. MAIN Among 8363 women, 6077 (72.7%) were using one or more cycle apps at baseline. A total of 122 separate apps were reported by women. We designated five of these apps before analysis as more likely to be effective (Clue, Fertility Friend, Glow, Kindara, Ovia; hereafter referred to as 'selected apps'). The use of any app at baseline was associated with 20% increased fecundability, with little difference between selected apps versus other apps (selected apps FR (95% CI): 1.20 (1.13, 1.28); all other apps 1.21 (1.13, 1.30)). In time-varying analyses, cycle app use was associated with 12-15% increased fecundability (selected apps FR (95% CI): 1.12 (1.04, 1.21); all other apps 1.15 (1.07, 1.24)). When apps were used at baseline with one or more fertility indicators, there was higher fecundability than without fertility indicators (selected apps with indicators FR (95% CI): 1.23 (1.14, 1.34) versus without indicators 1.17 (1.05, 1.30); other apps with indicators 1.30 (1.19, 1.43) versus without indicators 1.16 (1.06, 1.27)). In time-varying analyses, results were similar when stratified by time trying at study entry (<3 vs. 3-6 cycles) or cycle regularity. For use of the selected apps, we observed higher fecundability among women FR 1.33 (1.05-1.67). LIMITATIONS, Neither regularity nor intensity of app use was ascertained. The prospective time-varying assessment of app use was based on questionnaires completed every 2 months, which would not capture more frequent changes. Intercourse frequency was also reported retrospectively and we do not have data on timing of intercourse relative to the fertile window. Although we controlled for a wide range of covariates, we cannot exclude the possibility of residual confounding (e.g. choosing to use an app in this observational study may be a marker for unmeasured health habits promoting fecundability). Half of the women in the study received a free premium subscription for one of the apps (Fertility Friend), which may have increased the overall prevalence of app use in the time-varying analyses, but would not affect app use at baseline. Most women in the study were college educated, which may limit application of results to other populations. Use of a cycle app, especially in combination with observation of one or more fertility indicators (basal body temperature, cervical fluid, cervix position and/or urine LH), may increase fecundability (per-cycle pregnancy probability) by about 12-20% for couples trying to conceive. We did not find consistent evidence of improved fecundability resulting from use of one specific app over another. STUDY FUNDING/COMPETING INTEREST(S): This research was supported by grants, R21HD072326 and R01HD086742, from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, USA. In the last 3 years, Dr L.A.W. has served as a fibroid consultant for AbbVie.com. Dr L.A.W. has also received in-kind donations from Sandstone Diagnostics, Swiss Precision Diagnostics, FertilityFriend.com and Kindara.com for primary data collection and participant incentives in the PRESTO cohort. Dr J.B.S. reports personal fees from Swiss Precision Diagnostics, outside the submitted work. The remaining authors have nothing to declare. N/A.
Fertility AwarenessMobile ApplicationsFertile Window IdentificationDigital Tools
Open Access
To characterize mobile fertility tracking applications (apps) to determine the use of such apps for women trying to conceive by identifying the fertile window.
An exploratory cross-sectional audit study was conducted of fertility tracking applications. Ninety out of a possible total 200 apps were included for full review. The main outcome measures were the underlying app method for predicting ovulation, the fertile window, or both, price to download and use the app, disclaimers and cautions, information and features provided and tracked, and app marketing strategies.
All the apps except one monitored the women's menstrual cycle dates. Most apps only tracked menstrual cycle dates (n = 49 [54.4%]). The remainder tracked at least one fertility-based awareness method (basal body temperature, cervical mucus, LH) (n = 41 [45.6%]). Twenty-five apps measured dates, basal body temperature, LH and cervical mucus (27.8%). Seventy-six per cent of apps were free to download with free apps having more desirable features, tracking more measures and having more and better quality educational insights than paid apps. Seventy per cent of apps were classified as feminine apps, 41% of which were pink in colour. Mobile fertility tracking apps are heterogenous in their underlying methods of predicting fertile days, the price to obtain full app functionality, and in content and design. Unreliable calendar apps remain the most commonly available fertility apps on the market. The unregulated nature of fertility apps is a concern that could be addressed by app regulating bodies. The possible benefit of using fertility apps to reduce time to pregnancy needs to be evaluated.
Does sexual intercourse in the implantation time window (5-9 days after ovulation) reduce fecundability? After adjustment for intercourse in the fecund window and clustering by couple, there was no association between intercourse in the implantation time window and fecundity. Previous research has suggested an association between intercourse in the peri-implantation time window (5-9 days after estimated ovulation) and reduced fecundability. STUDY DESIGN, SIZE, We used data from the FERTILI study, a prospective observational study conducted in five European countries, with data collected from 1992 to 1996. PARTICIPANTS/MATERIALS, SETTING, Women who were experienced in fertility awareness tracking kept a daily diary of cervical mucus observations, basal body temperature measurements, coitus and clinically identified pregnancy. We estimated the day of ovulation as cycle length minus 13 days. From 661 women, 2606 cycles had intercourse during the fecund window (from 5 days before to 3 days after the estimated day of ovulation), resulting in 418 pregnancies (conception cycles). An established Bayesian fecundability model was used to estimate the fecundability ratio (FR) of peri-implantation intercourse on fecundability, while adjusting for each partner's age, prior pregnancy, the couple's probability of conception and intercourse pattern(s). We conducted sensitivity analyses estimating ovulation as cycle length minus 12 days, or alternatively, as the peak day of estrogenic cervical mucus. MAIN There was no effect of peri-implantation adjusted FR for three or more acts of peri-implantation 1.00, 95% 0.76-1.13. Results were essentially the same with sensitivity analyses. There was an inverse relationship between frequency of intercourse in the fecund window and intercourse in the peri-implantation window. LIMITATIONS, Women with known subfertility were excluded from this study. Many couples in the study were avoiding pregnancy during much of the study, so 61% of otherwise eligible cycles in the database were not at meaningful risk of pregnancy and did not contribute to the analysis. Some couples may not have recorded all intercourse. We believe the current balance of evidence does not support a recommendation for avoiding intercourse in the peri-implantation period among couples trying to conceive. STUDY FUNDING/COMPETING INTEREST(S): No external funding. The authors have no potential competing interests. N/A.
This study explores differences in the use of CycleProGo™ (CPG), a fertility-tracking app developed by Couple to Couple League (CCL), between those exposed to it as a part of natural family planning (NFP) instruction versus those who find it on their own. An anonymous data set of 17,543 CPG accounts opened between April 2013 and June 2016 was used for analysis. Nonmember users opened the most accounts (58 percent, n = 10,134), CCL members represented 38 percent (n = 6,758) of new accounts, and 207 CCL teachers (4 percent) were using CPG for personal charting. Significantly more nonmember accounts had zero days of use after the initial opening compared to CCL member accounts (61 percent vs. 23 percent, respectively, χ(2) = 2,405.9, p < .001). Conversely, significantly more CCL member accounts were used for ninety days or longer than nonmember accounts (47 percent vs. 13 percent, respectively, χ(2) = 2,404.2, p < .001). CCL students-those who began using the app as part of a formal NFP teaching curriculum-were more likely to use the app for > six cycles compared to nonmembers. In accounts with at least one complete cycle, CCL students were the most diligent at daily recording (95 percent of cycle days with observation recorded) followed by CCL members (88 percent) and nonmembers (76 percent). CCL teachers had the lowest frequency of cycle days with a recorded observation (73 percent). Within each cohort, accounts with > six recorded cycles had a lower proportion of cycle days with an observation recorded, likely reflecting increasing knowledge of their personal fertility patterns. Long-term users who had no known formal training in NFP still had the lowest proportion cycle days with a fertility observation. We conclude formal NFP instruction increases the probability of long-term app use, and regardless of training, long-term users will likely record observations on about 70 percent of cycle days.
"CycleProGo™ users with NFP training were more persistent and diligent about daily data input than those without training."
This study reports on 632 cycles from 105 women who were using the CREIGHTON MODEL FertilityCare™ System to avoid pregnancy and had either a serious reason to avoid pregnancy or some degree of a lack of confidence. A progesterone level was drawn on the third day after the Peak Day as they were charting, and if the progesterone level was 2.3 ng/mL or greater, then ovulation was determined to have passed. If the level was greater than 3.0 ng/mL, this indicated that an absolute period of infertility had begun. In these cases, no pregnancies were observed. In the 27 cycles in which a specific follow-up relative to pregnancy could not be definitively determined, the progesterone levels in all cases were 2.3 ng/mL or greater with 23 of the 27 cycles being 3.1 ng/mL or greater. It is highly unlikely that any of those became pregnant as well. These cycles were collected over thirteen years (2004-2016). Two case presentations are also a part of this article of two families in which the couples had very serious reasons to avoid pregnancy. In these two couples, each of the women was multi-gravid and had no evidence of subfertility or infertility. They used the family planning progesterone level (the Peak Day +3 progesterone level) for a total of 167 cycles over a number of years successfully without a subsequent pregnancy.
This article presents a thirteen-year effort to evaluate the serum progesterone level on the third day after the Peak Day as observed by women charting the CREIGHTON MODEL FertilityCare™ System. It is known that the Peak Day is associated with ovulation, and if the progesterone reaches a certain level, then an absolute period of infertility should follow. In fact, this is what this study reflects.
This article reviews the competition of two natural family planning methods in the mid-1970s when the Catholic Natural Family Planning program was underway in Korea. The Catholic Church, emphasizing the natural law, has recommended Natural Family Planning (NFP), a method of regulating childbirth by abstinence during the fertile period, since the mid-twentieth century. However, a group of gynecologists working at St. Mary's Hospital, a Catholic general hospital in Korea, questioned the utility of NFP. As an alternative, they proposed the method of Ovulation Regulation (OR), which regulates the menstrual cycle by inducing ovulation with steroids agents. This seemed to be no different than contraception with oral contraceptives disapproved of by the Catholic Church, but many doctors who advocated OR thought that this could be a new 'natural' family planning method to replace NFP. What is noteworthy here is the fact that not only NFP advocates, but also OR advocates attempted to justify their methods based on the authority of the 'nature.' In the debate over natural family planning methods, nature's legitimacy was given premise, not the object of doubt. Rather, the issue was the definition of nature. First, 'nature' in NFP signifies 'innate nature,' which excludes human intervention. According to this point of view, OR with steroids agents could not be natural. On the contrary, a group of doctors who advocated OR considered nature 'primal completeness.' If the natural order of the menstrual cycle could be restored, the artificial intervention of the administration of steroids was not a problem. Thus, both groups defended their arguments by redefining nature, rather than raising an issue of nature itself. The competition between 'innate nature' and 'complete nature,' a proxy war between NFP and OR, resulted in the victory of the former as the meaning of nature became fixed. Advocates of NFP pointed out that OR inhibits other physiological functions in the process of inducing ovulation, suggesting that the idea of 'complete nature' could never be achieved. The meaning of nature could no longer be controversial. Since the intervention was unnatural, nature meant innateness, the absence of intervention. Accordingly, the Catholic Bishops of Korea approved the Billings Method, a kind of the NFP, as the official family planning method, and gynecologists at St. Mary's Hospital of Korea also focused on the development and supplementation of the Billings Method. In short, the debate over the methods of natural family planning in mid1970s Korea was a clash of 'innate nature' and 'complete nature.' As a result, this confirmed the limitations of medical practice and reconfirmed the power of magisterium, the church's authority over medical practice.
We examined the association between incorrect knowledge of ovulation and unintentional pregnancy and child among young women in sub-Saharan Africa countries. Using Pearson's Chi-square, t test, multiple logistic regression, and likelihood ratio test, we analyzed Demographic and Health Survey data (2008-2017) of 169,939 young women (15-24 year). The range of prevalence of incorrect knowledge of ovulation was 51% in Comoros and 89.6% in Sao Tome and Principe, while unintentional pregnancy ranged between 9.4% in the Republic of Benin and 59.6% in Namibia. The multivariate result indicates a strong association between incorrect knowledge of ovulation and unintentional pregnancy (OR = 1.17; p < 0.05) and unintentional child (OR = 1.15; p < 0.05). Adolescent women (15-19) generally have poor knowledge of ovulation and are more likely to report an unintentional pregnancy/child than women between ages 20-24. To reduce the burden of unintentional child/pregnancy in Africa, fertility knowledge should not only be improved on but must consider the sociocultural context of women in different countries that might affect the adoption of such intervention programs. Pragmatic efforts, such as building community support for young women to discuss and share their experiences with professionals and educate them on fertility and sexuality, are essential.
Body LiteracyFertility App EvaluationMobile Health ApplicationsmHealth Evidence
There has been a phenomenal worldwide increase in the development and use of mobile health applications (mHealth apps) that monitor menstruation and fertility. Critics argue that many of the apps are inaccurate and lack evidence from either clinical trials or user experience. The aim of this scoping review is to provide an overview of the research literature on mHealth apps that track menstruation and fertility. This project followed the PRISMA Extension for Scoping Reviews. The ACM, CINAHL, Google Scholar, PubMed and Scopus databases were searched for material published between 1 January 2010 and 30 April 2019. Data summary and synthesis were used to chart and analyse the data. In total 654 records were reviewed. Subsequently, 135 duplicate records and 501 records that did not meet the inclusion criteria were removed. Eighteen records from 13 countries form the basis of this review. The papers reviewed cover a variety of disciplinary and methodological frameworks. Three fertility and reproductive health tracking, pregnancy planning, and pregnancy prevention. Motivations for fertility app use are varied, overlap and change over time, although women want apps that are accurate and evidence-based regardless of whether they are tracking their fertility, planning a pregnancy or using the app as a form of contraception. There is a lack of critical debate and engagement in the development, evaluation, usage and regulation of fertility and menstruation apps. The paucity of evidence-based research and absence of fertility, health professionals and users in studies is raised.
Fertility AwarenessSigns and SymptomsPregnancy PreventionFertility Signs
Simmons RG et al., 2020·Best Pract Res Clin Obstet Gynaecol
Fertility awareness-based methods (FABMs) of family planning involve monitoring various signs and symptoms of fertility during the menstrual cycle to identify the "fertile window," or the days of the cycle when unprotected intercourse is most likely to result in pregnancy. Signs and symptoms include menstrual cycle length, basal body temperature, urinary hormone measurements, and/or cervical fluid and may be used alone or in combination. Fertility signs reflect both physiological changes during the menstrual cycle and the life cycle of the ovum and sperm. Women learn to observe or measure and interpret these signs according to the instructions of their chosen FABM and avoid unprotected intercourse on fertile days. FABMs are appropriate for those who choose to use them, are able and willing to observe one or more fertility signs, and are in relationships that support the use of a coitus-related method such as a condom or abstaining from intercourse on fertile days.
Najmabadi S et al., 2020·Paediatr Perinat Epidemiol
There is variability between women for days of menstrual bleeding, cycle lengths, follicular phase lengths, and luteal phase lengths, related to age and parity. To describe total cycle length; anovulatory cycles; follicular and luteal phase lengths; and days and intensity of menstrual and non-menstrual bleeding in women without known subfertility over the course of 1 year. 581 women (3,324 cycles) with no known subfertility (18-40 years of age) were followed for up to 1 year. Women recorded vaginal bleeding and mucus discharge daily. We used the peak day of cervical mucus as the estimated day of ovulation and the last day of the follicular phase. We used generalised linear mixed models stratified by age and parity to describe menstrual cycle parameters. The majority of women were <30 years of age (74.5%), non-Hispanic White (88.6%), and nulliparous (70.4%). The mean menses length was 6.2 (1.5) days, median 6; cycle length 30.3 (6.7) days, median 29; follicular phase length 18.5 (6.5) days, median 17; and luteal phase length 11.7 (2.8) days, median 12. Nulliparous women aged ≥30 years vs nulliparous women aged <30 had shorter cycles (29.2 days, 95% confidence interval (CI) 27.8, 30.7 vs 31.5 days, 95% CI 30.8, 32.2) and shorter follicular phases (17.6 days, 95% CI 16.2, 18.9 vs 19.6 days, 95% CI 18.9, 20.2). Among all women, within-woman differences between the longest and shortest menses length >3 days, total cycle length >7 days, follicular phase >7 days, and luteal phase >3 days were found in 11.6%, 43.0%, 41.7%, and 58.8% of women, respectively. Our findings confirm variability between women of menstrual cycle parameters related to age and parity, and also highlight within-woman variability in the follicular and luteal phases.
Previous research has demonstrated that women instructed in fertility awareness methods can identify the Peak Day of cervical mucus discharge for each menstrual cycle, and the Peak Day has high agreement with other indicators of the day of ovulation. However, previous studies enrolled experienced users of fertility awareness methods or were not fully blinded. To assess the agreement between cervical mucus Peak Day identified by fertile women without prior experience on assessing cervical mucus discharge with the estimated day of ovulation (1 day after urine luteinising hormone surge). This study is a secondary analysis of data from a randomised trial of the Creighton Model FertilityCare(TM) System (CrM), conducted 2003-2006, for women trying to conceive. Women who had no prior experience tracking cervical mucus recorded vulvar observations daily using a standardised assessment of mucus characteristics for up to seven menstrual cycles. Four approaches were used to identify the Peak Day. The referent day was defined as one day after the first identified day of luteinising hormone (LH) surge in the urine, assessed blindly. The percentage of agreement between the Peak Day and the referent day of ovulation was calculated. Fifty-seven women with 187 complete cycles were included. A Peak Day was identified in 117 (63%) cycles by women, 185 (99%) cycles by experts, and 187 (100%) by computer algorithm. The woman-picked Peak Day was the same as the referent day in 25% of 117 cycles, within ±1 day in 58% of cycles, ±2 days in 84%, ±3 days in 87%, and ±4 days in 92%. The ±1 day and ± 4 days' agreement was 50% and 90% for the expert-picked and 47% and 87% for the computer-picked Peak Day, respectively. Women's daily tracking of cervical mucus is a low-cost alternative for identifying the estimated day of ovulation.
Fertility AwarenessReproductive MicrobiomeSexual SelectionEvolutionary Biology
Open Access
All multicellular organisms host microbial communities in and on their bodies, and these microbiomes can have major influences on host biology. Most research has focussed on the oral, skin, and gut microbiomes, whereas relatively little is known about the reproductive microbiome. Here, we review empirical evidence to show that reproductive microbiomes can have significant effects on the reproductive function and performance of males and females. We then discuss the likely repercussions of these effects for evolutionary processes related to sexual selection and sexual conflict, as well as mating systems and reproductive isolation. We argue that knowledge of the reproductive microbiome is fundamental to our understanding of the evolutionary ecology of reproductive strategies and sexual dynamics of host organisms.
In 2006-2008, 610 premenopausal, spontaneously menstruating women in the Metro Vancouver region participated in a Canadian Institutes of Health Research (CIHR)-funded singlecycle in which they collected first morning urine specimens for estrogen and progesterone metabolites1. Following that study, after analyses, we retrieved the remaining urine specimens from the analyzing laboratory (University of Washington). We sorted data so that samples from all those women who were anovulatory by the two combined urinary steroid evaluation methods2,3, plus from those who were ovulatory with the highest and the lowest urinary hormone values were shipped to Health Canada (HC) via Dr. Warren Foster’s laboratory at McMaster University. Those data on flame retardant contaminants in women’s urine have been published4, but the cycle-phase specific data are still in analysis (personal communication, S Kalyan, 2019). In 2017, HC basic scientists launched applications to HC to fund a similar study to assess flame retardant excretory changes in the same population/locale 10 years later. This application was funded in 2018 at Health Canada with Dr. JC Prior as a collaborator. Extensive negotiations by CeMCOR and HC scientists ensued about funding the process of obtaining these follow-up specimens. CeMCOR managed to obtain a HC agreement to fund the minimal cost of recruiting, training and obtaining two menstrual phase-specific urine specimens from 250 Metro Vancouver women. Because of the lack of a progesterone threshold for ovulation, we will collect one follicular and one luteal/premenstrual urine sample per woman. However, this time we will better characterize the ovulatory cycle using a validated quantitative basal temperature method5,6 that can assess luteal phase length as well as the presence/absence of evidence for ovulation. In addition we will collect serial salivary progesterone and estradiol values measured by the state-of-the-art sensitive and specific tandem mass spectrometry (LC-MS/MS) methods7 to use as the gold standard for an ovulatory cycle. There is increasing evidence that many variables differ across women’s two follicular and luteal7-10. These real and potential differences in metabolism may alter the susceptibility of women to environment exposures, and also could change their urinary elimination. Those are the root reasons for doing this study.
Body temperature is a common method in menstrual cycle phase tracking because of its biphasic form. In ambulatory studies, different skin temperatures have proven to follow a similar pattern. The aim of this pilot study was to assess the applicability of nocturnal finger skin temperature based on a wearable Oura ring to monitor menstrual cycle and predict menstruations and ovulations in real life. Volunteer women (n = 22) wore the Oura ring, measured ovulation through urine tests, and kept diaries on menstruations at an average of 114.7 days (SD 20.6), of which oral temperature was measured immediately after wake-up at an average of 1.9 cycles (SD 1.2). Skin and oral temperatures were compared by assessing daily values using repeated measures correlation and phase mean values and differences between phases using dependent t-test. Developed algorithms using skin temperature were tested to predict the start of menstruation and ovulation. The performance of algorithms was assessed with sensitivity and positive predictive values (true positive defined with different windows around the reported day). Nocturnal skin temperatures and oral temperatures differed between follicular and luteal phases with higher temperatures in the luteal phase, with a difference of 0.30 °C (SD 0.12) for skin and 0.23 °C (SD 0.09) for oral temperature (p < 0.001). Correlation between skin and oral temperatures was found using daily temperatures (r = 0.563, p < 0.001) and differences between phases (r = 0.589, p = 0.004). Menstruations were detected with a sensitivity of 71.9-86.5% in window lengths of ±2 to ±4 days. Ovulations were detected with the best-performing algorithm with a sensitivity of 83.3% in fertile window from - 3 to + 2 days around the verified ovulation. Positive predictive values had similar percentages to those of sensitivities. The mean offset for estimations were 0.4 days (SD 1.8) for menstruations and 0.6 days (SD 1.5) for ovulations with the best-performing algorithm. Nocturnal skin temperature based on wearable ring showed potential for menstrual cycle monitoring in real life conditions.
To quantify the frequency of use of selected fertility awareness indicators and to assess their influence on fecundability. Web-based prospective cohort study. Not applicable. PATIENT(S): Female pregnancy planners, aged 21-45 years, attempting conception for ≤6 cycles at study entry. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): We ascertained time to pregnancy, in menstrual cycles, with bimonthly questionnaires. We estimated adjusted fecundability ratios (FRs) and confidence intervals (CIs) using proportional probabilities models, controlling for age, income, education, smoking, intercourse frequency, and other lifestyle and reproductive factors. RESULT(S): A total of 5,688 women were analyzed, with a mean age of 29.9 years and mean time trying of 2.1 cycles at baseline; 30% had ever been pregnant. At baseline, 75% were using one or more fertility indicators (counting days or charting menstrual cycles [71%], measuring basal body temperature [BBT, 21%], monitoring cervical fluid [39%], using urine LH tests [32%], or feeling for changes in position of the cervix [12%]). Women using any fertility indicator at baseline had higher subsequent fecundability (adjusted FR 1.25, 95% CI 1.16-1.35) than those not using any fertility indicators. For each individual indicator, adjusted FRs ranged from 1.28-1.36, where 1.00 would indicate no relation with fecundability. The adjusted FR for women using a combination of charting days, cervical fluid, and urine LH was 1.48 (95% CI 1.31-1.67) relative to women using no fertility indicators. CONCLUSION(S): In a North American preconception cohort study, use of fertility indicators indicating the fertile window was common, and was associated with greater fecundability.
Women wishing to conceive are largely unaware of fertility symptoms at the time of ovulation. This study investigated the effectiveness of fertility-awareness in achieving pregnancy, particularly fertile mucus pattern, in the context of infertility. The 384 eligible participants were taken from consecutive women desiring pregnancy who attended 17 Australian Billings Ovulation Method(®) clinics from 1999-2003. This cohort included couples with infertility ≥12 months (51%) and female age >35 years (28%). Under fertility-awareness instruction, pregnancy was achieved by 240 couples (62.5%) after maximum follow-up of two years. Mucus symptom observations effectively stratified 'low pregnancy-potential' (35.2%) and 'high pregnancy-potential' groups. Pregnancy rates were ∼30% higher in the latter group (44.4% versus 72.3%) in addition to consistent effects observed on pregnancy achievements within subgroups defined by prognostic factors such as duration of infertility (p = 0.001) and increasing female age (p = 0.04). Fertile symptoms were also associated with significantly shorter time to conception (4.2 versus 6.4 months) in a survival analysis (p = 0.003). Billings Ovulation Method(®) observations strongly predicted successful conception. This has the capacity to provide a rapid, reliable and cost-effective approach to stratifying fertility potential, including directing timely and targeted investigations/management, and is accessible for women who may be remote from primary or specialist care.
Women trying to conceive are increasingly using fertility-tracking software applications to time intercourse. This study evaluated the difference in conception rates between women trying to conceive using an application-connected ovulation test system, which measures urinary luteinizing hormone and an estrogen metabolite, versus those trying without using ovulation testing. This home-based study involved 844 volunteers aged 18-40 years seeking to conceive. Volunteers randomized to the test arm were required to use the test system for the duration of the study while those randomized to the control arm were instructed not to use ovulation testing. Pregnancy rate differences across one and two cycles between the two groups were examined. Volunteers in the test (n = 382) and control arms (n = 403) had similar baseline demographics. The proportion of women pregnant after one cycle was significantly greater in the test arm (25.4%) compared with the control arm (14.7%; p < 0.001). After two cycles, there continued to be a greater proportion of women pregnant in the test arm compared with the control arm (36.2% vs. 28.6%; p = 0.026). In the test arm, volunteers had intercourse less frequently per cycle compared with those not using ovulation testing (9 [range: 1-60] vs. 10 [range: 1-50]; p = 0.027), but were more likely to target intercourse to a particular part of their cycle compared with those not using ovulation testing (88.5% vs. 57.8%; p < 0.001). Using the test system to time intercourse within the fertile window increases the likelihood of conceiving within two menstrual cycles.
Menstrual CycleDigital Health DataApp-Based TrackingBig Data
For most women of reproductive age, assessing menstrual health and fertility typically involves regular visits to a gynecologist or another clinician. While these evaluations provide critical information on an individual's reproductive health status, they typically rely on memory-based self-reports, and the results are rarely, if ever, assessed at the population level. In recent years, mobile apps for menstrual tracking have become very popular, allowing us to evaluate the reliability and tracking frequency of millions of self-observations, thereby providing an unparalleled view, both in detail and scale, on menstrual health and its evolution for large populations. In particular, the primary aim of this study was to describe the tracking behavior of the app users and their overall observation patterns in an effort to understand if they were consistent with previous small-scale medical studies. The secondary aim was to investigate whether their precision allowed the detection and estimation of ovulation timing, which is critical for reproductive and menstrual health. Retrospective self-observation data were acquired from two mobile apps dedicated to the application of the sympto-thermal fertility awareness method, resulting in a dataset of more than 30 million days of observations from over 2.7 million cycles for two hundred thousand users. The analysis of the data showed that up to 40% of the cycles in which users were seeking pregnancy had recordings every single day. With a modeling approach using Hidden Markov Models to describe the collected data and estimate ovulation timing, it was found that follicular phases average duration and range were larger than previously reported, with only 24% of ovulations occurring at cycle days 14 to 15, while the luteal phase duration and range were in line with previous reports, although short luteal phases (10 days or less) were more frequently observed (in up to 20% of cycles). The digital epidemiology approach presented here can help to lead to a better understanding of menstrual health and its connection to women's health overall, which has historically been severely understudied.
### What you need to know Fertility awareness based methods of contraception are increasingly being used for pregnancy prevention.1 In the US, the proportion of contraceptive users who choose such methods has grown from 1% in 2008 to approximately 3% in 2014.12 Relative to other methods of pregnancy prevention, however, substantial misinformation exists around fertility awareness based methods of contraception, particularly about the effectiveness of specific methods and how to use them. Providers who offer family planning counselling can promote correct and consistent use of the chosen method by helping people find a method that best fits their individual lifestyle, preferences, and goals.3 This article aims to help clinicians counsel people about fertility awareness based methods for pregnancy prevention by explaining the different methods, the evidence base for their effectiveness, and practical considerations for use. Fertility awareness based methods are devised on the premise that sexual intercourse can only lead to pregnancy during approximately 6-9 days of the menstrual cycle, commonly referred to as the “fertile window” (or fecund window, box 1).5 …
Progesterone rises \~24-36 h after ovulation. Past studies using ultrasound-confirmed ovulation have shown that three consecutive tests with a threshold of 5μg/mL of urine progesterone (pregnanediol-3-glucuronide, PDG), taken after the luteinizing hormone (LH) surge, confirmed ovulation with 100% specificity. The purpose of this study was to a evaluate a new urine PDG self-test to retrospectively confirm ovulation in women who were monitoring ovulation using a hormonal fertility monitor. Thirteen women of reproductive age were recruited to test urine PDG while using their home hormonal fertility monitor. The monitor measured the rise in estrogen (estrone-3-glucuronide, E3G) and LH to estimate the fertile phase of the menstrual cycle. The women used an online menstrual cycle charting system to track E3G, LH and PDG levels for four menstrual cycles. The participants (Mean age 33.6) produced 34 menstrual cycles of data (Mean length 28.4 days), 17 of which used a PDG test with a threshold of 7μg/mL and 17 with a threshold of 5μg/mL. In the cycles that used the 7μg/mL test strips, 59% had a positive confirmation of ovulation, and with the 5μg/mL test strips, 82% of them had a positive confirmation of ovulation. The 5μg/mL PDG test confirmed ovulation in 82% of cycles and could assist women in the evaluation of the luteal progesterone rise of their menstrual cycle.
Fertility AwarenessScientific EvidenceNatural Family PlanningScientific Foundation
Berglund Scherwitzl E et al., 2019·Eur J Contracept Reprod Health Care
The aim of the study was to compare the effect of previously used contraceptive methods on women's shortand long-term fecundity. Use of hormonal contraception (HC) was compared with the use of a contraceptive mobile application (app). This real-life prospective observational study comprised 2874 women who were attempting to become pregnant using the Natural Cycles mobile app to monitor their fertility. The women registered to use the app between August 2014 and June 2016 with the intention of planning a pregnancy and had previously either used the same app to prevent pregnancy or had recently discontinued HC use. We calculated the average time to pregnancy (TTP) for all women who became pregnant during the study and performed Kaplan-Meier life-table analysis to examine the cumulative probabilities of pregnancy for all women in the study. The average TTP was 2.3 (95% confidence interval [CI] 2.1, 2.4) and 3.7 (95% CI 3.4, 3.9) cycles for women who had previously used Natural Cycles and HC, respectively. The time to reach 30% pregnancy probability for women previously on HC was 1.6 (95% CI 1.5, 1.8) times longer than for women previously using Natural Cycles. There was no significant difference in the 13 cycle cumulated pregnancy probability between the two groups. The results show that fertility awareness-based methods of contraception increase short-term pregnancy rates relative to HC, but have no effect on long-term pregnancy rates.
Ovulation confirmation is a fundamental component of the evaluation of infertility. To inform the design of a larger clinical trial to determine the effectiveness of a new home-based pregnanediol glucuronide (PDG) urine test to confirm ovulation when compared with the standard of serum progesterone. In this observational prospective cohort study (single group assignment) in an urban setting (stage 1), a convenience sample of 25 women (aged 18-42 years) collected daily first morning urine for luteinisinghormone (LH), PDG and kept a daily record of their cervical mucus for one menstrual cycle. Serum progesterone levels were measured to confirm ovulation. Sensitivity and specificity were used as the main outcome measures. Estimation of number of ultrasound (US)-monitored cycles needed for a future study was done using an exact binomial CI approach. Recruitment over 3 months was achieved (n=28) primarily via natural fertility regulation social groups. With an attrition rate of 22%, specificity of the test was 100% for confirming ovulation. Sensitivity varied depending on whether a peak-fertility mucus day or a positive LH test was observed during the cycle (85%-88%). Fifty per cent of participants found the test results easy to determine. A total of 73 US-monitored cycles would be needed to offer a narrow CI between 95% and 100%. This is first study to clinically evaluate this test when used as adjunct to the fertility awareness methods. While this pilot study was not powered to validate or test efficacy, it helped to provide information on power, recruitment and retention, acceptability of the procedures and ease of its use by the participants. Given this test had a preliminary result of 100% specificity, further research with a larger clinical trial (stage 2) is recommended to both improve this technology and incorporate additional approaches to confirm ovulation. NCT03230084.
Previous research examining physiological changes across the menstrual cycle has considered biological responses to shifting hormones in isolation. Clinical studies, for example, have shown that women's nightly basal body temperature increases from 0.28 to 0.56 ˚C following postovulation progesterone production. Women's resting pulse rate, respiratory rate, and heart rate variability (HRV) are similarly elevated in the luteal phase, whereas skin perfusion decreases significantly following the fertile window's closing. Past research probed only 1 or 2 of these physiological features in a given study, requiring participants to come to a laboratory or hospital clinic multiple times throughout their cycle. Although initially designed for recreational purposes, wearable technology could enable more ambulatory studies of physiological changes across the menstrual cycle. Early research suggests that wearables can detect phase-based shifts in pulse rate and wrist skin temperature (WST). To date, previous work has studied these features separately, with the ability of wearables to accurately pinpoint the fertile window using multiple physiological parameters simultaneously yet unknown. In this study, we probed what phase-based differences a wearable bracelet could detect in users' WST, heart rate, HRV, respiratory rate, and skin perfusion. Drawing on insight from artificial intelligence and machine learning, we then sought to develop an algorithm that could identify the fertile window in real time. We conducted a prospective longitudinal study, recruiting 237 conception-seeking Swiss women. Participants wore the Ava bracelet (Ava AG) nightly while sleeping for up to a year or until they became pregnant. In addition to syncing the device to the corresponding smartphone app daily, women also completed an electronic diary about their activities in the past 24 hours. Finally, women took a urinary luteinizing hormone test at several points in a given cycle to determine the close of the fertile window. We assessed phase-based changes in physiological parameters using cross-classified mixed-effects models with random intercepts and random slopes. We then trained a machine learning algorithm to recognize the fertile window. We have demonstrated that wearable technology can detect significant, concurrent phase-based shifts in WST, heart rate, and respiratory rate (all P<.001). HRV and skin perfusion similarly varied across the menstrual cycle (all P<.05), although these effects only trended toward significance following a Bonferroni correction to maintain a family-wise alpha level. Our findings were robust to daily, individual, and cycle-level covariates. Furthermore, we developed a machine learning algorithm that can detect the fertile window with 90% accuracy (95% CI 0.89 to 0.92). Our contributions highlight the impact of artificial intelligence and machine learning's integration into health care. By monitoring numerous physiological parameters simultaneously, wearable technology uniquely improves upon retrospective methods for fertility awareness and enables the first real-time predictive model of ovulation.
Fertility AwarenessSmartphone ApplicationsTypical and Perfect UseFertile Window Estimation
Jennings V et al., 2019·Eur J Contracept Reprod Health Care
Dynamic Optimal Timing (Dot) is a smartphone application (app) that estimates the menstrual cycle fertile window based on the user's menstrual period start dates. Dot uses machine learning to adapt to cycles over time and informs users of 'low' and 'high' fertility days. We investigated Dot's effectiveness, calculating perfectand typical-use failure rates. This prospective, 13 cycle observational study (ClinicalTrials.gov NCT02833922) followed 718 women who were using Dot to prevent pregnancy. Participants contributed 6616 cycles between February 2017 and October 2018, providing data on menstrual period start dates, daily sexual activity and prospective intent to prevent pregnancy. We determined pregnancy through participant-administered urine pregnancy tests and/or written or verbal confirmation. We calculated perfectand typical-use failure rates using multi-censoring, single-decrement life-table analysis, and conducted sensitivity, attrition and survival analyses. The perfect-use failure rate was calculated to be 1.0% (95% confidence interval [CI]: 0.9%, 2.9%) and the typical-use failure rate was 5.0% (95% CI: 3.4%, 6.6%) for women aged 18-39 (n = 718). Survival analyses identified no significant differences among age or racial/ethnic groups or women in different types of relationships. Attrition analyses revealed no significant sociodemographic differences, except in age, between women completing 13 cycles and those exiting the study earlier. Dot's effectiveness is within the range of other user-initiated contraceptive methods.
NaProTECHNOLOGYSeminary and Clergy FormationNFP Curriculum OutcomesHumanae Vitae Implementation
A special course on Marriage, the Family and Human Sexuality was established at Kenrick-Glennon Seminary in St. Louis so as to assist the seminarians in their better understanding of the Church's teaching relative to natural methods of family planning and women's health care. This article compares the response at the beginning of this three-credit semester course to the same seven-item questionnaire given at the conclusion of the course. The preand postcourse scores were calculated for each of the questions. The scores obtained after the course were all significantly higher than they were before the course with p values ranging from 0.01 to <0.0001. Four of the items showed marked improvement including an understanding of the church's teaching related to natural methods, current methods of natural family planning, the impact of a natural method on a couple's marriage, and also the impact of a natural method on family life. Statistically significant improvement was also seen in their understanding of the topic of natural family planning and the Creighton Model System and its relevance toward the seminarian's vocation, the use of the methods to either achieve or avoid pregnancy, and how contraception and abortion are linked. In these last three items, the level of statistical significance was quite high, although not as high as the other four items. There were 104 seminarians over an eight-year period of time, who provided answers to these questions, both before and after the course. This course was modeled after a course that was initiated at the Pope Paul VI Institute for the Study of Human Reproduction, which was for priests, seminarians, and Catholic leaders, titled Love & Life Unlimited. This is an evaluation of a ten-point, seven-question questionnaire that was utilized at the beginning of a course at Kenrick Seminary in Marriage, Sexuality, Creighton Model and NaProTECHNOLOGY. The same questionnaire was given to the students at the beginning of the course and then two to three months later at the conclusion of the three-credit course. The results show that there is a significant improvement in the seminarians' knowledge and general attitude about natural methods of family planning and suggests that such courses would be beneficial to establish in seminaries throughout the country.
The ability to accurately predict ovulation at-home using low-cost point-of-care diagnostics can be of significant help for couples who prefer natural family planning. Detecting ovulation-specific hormones in urine samples and monitoring basal body temperature are the current commonly home-based methods used for ovulation detection; however, these methods, relatively, are expensive for prolonged use and the results are difficult to comprehend. Here, we report a smartphone-based point-of-care device for automated ovulation testing using artificial intelligence (AI) by detecting fern patterns in a small volume (<100 μL) of saliva that is air-dried on a microfluidic device. We evaluated the performance of the device using artificial saliva and human saliva samples and observed that the device showed >99% accuracy in effectively predicting ovulation.
Identifying the return of fertility with cervical mucus observations is challenging during the postpartum period. Use of urinary measurements of estrogen and progesterone can assist in understanding the return to fertility during this period. The purposes of this study were to describe the postpartum return of fertility by an analysis of total estrogen (TE) and pregnanediol glucuronide (PDG) profiles and to correlate these profiles with cervical mucus observations. Twenty-six participants collected urine samples during the postpartum period and recorded mucus scores. TE and PDG hormones were analyzed and compared with mucus scores. During amenorrhea, mucus reflected TE changes in only 35 percent of women; after amenorrhea, typical mucus patterns were seen in 33 percent of cycles. We concluded that postpartum mucus and hormone profiles are significantly dissociated but that monitoring urinary hormones may assist in identifying the return of fertility. We also identified different hormonal patterns in the return to fertility. The postpartum period is a challenging time for identifying the return of fertility. The purposes of this study were to describe the hormonal patterns during the return of fertility and to correlate these patterns with cervical mucus observations. Twenty-six postpartum women collected urine samples and recorded mucus scores. Urinary estrogen and progesterone hormones were analyzed and compared with mucus scores. Before the return of menses, mucus reflected hormonal changes in only 35 percent women and after first menses in 33 percent of cycles. We found that hormone profiles do not correlate well with mucus observations during the postpartum return of fertility.
Fertility AwarenessNFP Science State AssessmentModern NFP EffectivenessFuture Research Priorities
A one-day meeting of physicians, professional nurses, and scientists actively involved in Natural Family Planning (NFP) research was held to review the state of the science of NFP and consider future priorities. The (i) determine the gaps in research evidence for secure methods of NFP among women of all reproductive categories, (ii) determine the gaps in the research and development of new technology for providing NFP services, (iii) determine the gaps in the research that determine the benefits and challenges with use of NFP among married couples, and (iv) provide prioritized ideas for future research needs from the analysis of evidence gaps from objectives above. This article summarizes the discussion and conclusions drawn from topics reviewed. While much has been accomplished in the fifty years since Humane vitae, there are still many gaps to address. Five areas for future research in NFP were (1) well-designed method effectiveness studies among various reproductive categories including important subpopulations (postpartum, perimenopause, posthormonal contraceptive), normally cycling women (especially US women), and comparative studies between NFP methods; (2) validation studies to establish the benefit of charting fertility signs (both currently known and potential new indicators) as a screening tool for women's health issues; (3) ongoing independent evaluation of fertility monitoring apps to provide users perspective on the relative merits of each and to identify those most worthy of further effectiveness testing; (4) studies evaluating the impact of new technologies on NFP adoption, use, and persistence; and (5) creation of a shared database across various NFP methods to collaborate on shared research interests, longitudinal studies, and so on. This summarizes a meeting to review the scientific and medical progress related to natural family planning made in the 50 years since Humane Vitae and to define priorities for future work. Areas reviewed included the evidence for avoiding pregnancy in normally cycling, postpartum, and perimenopausal women, the impact of new technology, including fertility charting apps, on NFP, and the impact on relationships and personal well-being from use of NFP. Five priority focus areas for future research were also identified.
To summarize best available prospective data on typical and perfect use effectiveness of fertility awareness-based methods for avoiding pregnancy. We conducted a systematic review of studies published in English, Spanish, French, or German by June 2017 in MEDLINE, EMBASE, CINAHL, Web of Science, and ClinicalTrials.gov. We reviewed 8,755 unique citations and included 53 studies that contained 50 or greater women using a specific fertility awareness-based method to avoid pregnancy, calculated life table pregnancy probabilities or Pearl rates, and prospectively measured pregnancy intentions and outcomes. We systematically evaluated study quality. TABULATION, INTEGRATION, Of 53 included studies, we ranked 0 high quality, 21 moderate quality, and 32 low quality for our question of interest. Among moderate-quality studies, first-year typical use pregnancy rates or probabilities per 100 11.2-14.1 for the Standard Days Method, 13.7 for the TwoDay Method, 10.5-33.6 for the Billings Ovulation Method, 4-18.5 for the Marquette Mucus-only Method, 9.0-9.8 for basal body temperature methods, 13.2 for single-check symptothermal methods, 11.2-33.0 for Thyma double-check symptothermal methods, 1.8 for Sensiplan, 25.6 for Persona, 2-6.8 for the Marquette Monitor-only Method, and 6-7 for the Marquette Monitor and Mucus Method. First-year perfect use pregnancy rates or probabilities among moderate-quality studies were 4.8 for the Standard Days Method, 3.5 for the TwoDay Method, 1.1-3.4 for the Billings Ovulation Method, 2.7 for the Marquette Mucus Method, 0.4 for Sensiplan, 12.1 for Persona, and 0 for the Marquette Monitor. Studies on the effectiveness of each fertility awareness-based method are few and of low to moderate quality. Pregnancy rates or probabilities varied widely across different fertility awareness-based methods (and in some cases, within method types), even after excluding low-quality studies. Variability across populations studied precludes comparisons across methods.
This issue of Current Medical Research (CMR) includes studies that provide evidence that use of natural family planning (NFP) can be helpful for subfertile couples wishing to achieve a pregnancy, the effectiveness of a method of NFP during breastfeeding, and the effects of using NFP on marital relationships. This review also includes evidence on predicting the sex of a baby by timing intercourse, evidence that brain injuries can be reflected in changes in the menstrual cycle, and that women prefer methods of family planning that have no side effects. The issue ends with an in-depth review of new technologies that aid in the use of NFP. Topics covered include subfertile couples, breastfeeding, marriage, predicting the sex of a baby, brain injuries, and new technologies.
Ethics/PhilosophyHumanae Vitae 50th AnniversaryNFP Movement MilestonesReproductive Ethics Editorial
Natural family planning (NFP) methods have served many generations well, and in particular, the symptothermal or symptohormonal methods. The comparison of daily mucus and temperature records for individual cycles with daily hormone measurements, which is now possible, shows that some of the assumptions underlying NFP may not be completely accurate. The various methods are inadvertently depending on an element of chance, which, of course, cannot be known by the NFP user. However, it is statistically inevitable that such errors will result eventually in an unexpected pregnancy, and these discrepancies are the likely reason for the method failures. Further research and integration of home hormone measurements with NFP symptoms are needed.
Traditional NFP methods, based on the observations of temperature, mucus, and luteinizing hormone, can work well. However, these data are sometimes difficult to interpret, and significant changes in the variables are sometimes "missing" from some cycles. Changes in these variables are elicited by the estrogen and progesterone released from the ovaries. It follows that the direct measures of events in the ovaries are the levels of estrogen and progesterone or their derivatives in blood or urine. Measurements of urinary derivatives of estrogen and progesterone can be used to monitor the ovaries directly and are clearer indicators than traditional NFP methods.
Ethics/PhilosophyHumanae Vitae Anniversary ReflectionNFP Science Progress ReviewReproductive Ethics Editorial
The accuracy of prediction of ovulation by cycle apps and published calendar methods was determined by comparing to true probability of ovulation. A total of 949 volunteers collected urine samples for one entire menstrual cycle. Luteinizing hormone was measured to assign surge day, enabling probability of ovulation to be determined across different cycle lengths. Cycle-tracking apps were downloaded. As none provided their methodology, four published calendar-based standard days, rhythm, alternative rhythm and simple calendar method. The volunteer ovulation data was applied to the app/calendar methods to determine their accuracy. Mean cycle length was 28 days (range: 23-35); 34% of women believed they had a 28-day cycle, but only 15% did. No LH surge was seen for 99 women. Most likely day of ovulation for a 28-day cycle was day 16 (21%). Accuracy of ovulation prediction was no better than 21% by the apps. The standard days and rhythm methods were most likely to predict ovulation (70% and 89%, respectively) but had very low accuracy. Ovulation day varies considerably for any given menstrual cycle length, thus it is not possible for calendar/app methods that use cycle-length information alone to accurately predict the day of ovulation. NCT01577147. www.clinicaltrials.gov .
Contraception/ComparisonReproductive Outcome ConsequencesContraceptive Influence on Young WomenAdolescent Reproductive Health
Oral contraceptives (OCs) are often prescribed to adolescents and young adults for the treatment of health problems and to avoid unwanted pregnancies. We hypothesized that the use of OCs, among adolescents and young adults, is associated with a greater likelihood of pregnancy, abortion, sexually transmitted diseases (STDs), pelvic inflammatory disease (PID), and sexual behaviors that will enhance those problems (i.e., earlier sexual debut and more sexual partners) than adolescents and young adults not using OCs. To test this hypothesis, data from 1,365 adolescents and young adults in the 2011-2013 National Survey of Family Growth (NSFG) were used to describe the influence of ever use of OCs on ever having sex, sexual debut, multiple sexual partners, STDs, PID, pregnancy, and abortion. A secondary purpose was to evaluate protective factors from unhealthy sexual practices like religiosity, church attendance, and intact families. We found that the "ever use" of OCs by US adolescents and young adults results in a greater likelihood of ever having sex, STDs, PID, pregnancy, and abortion compared with those adolescents and young adults who never used OCs. Furthermore, those adolescents who ever used OCs had significantly more male sexual partners than those who never used OCs, and they also had an earlier sexual debut by almost two years. Conversely, we found that frequent church attendance, identification of the importance of religion, and having an intact family among adolescents were associated with less likelihood of unsafe sexual practices. We concluded that the use of OCs by adolescents and young adults might be considered a health risk. Further research is recommended to confirm these associations.
The purpose of this article was to show the correlation between contraceptive use in adolescents and negative sexual outcomes. We used data from the 2011-2013 NSFG and demonstrated that never married adolescents who used oral hormonal contraception were three times more likely to have an STD, have PID, and to become pregnant, and, surprisingly, ten times more likely of having an abortion compared to noncontracepting adolescents. These are outcomes that contraception is intended to prevent. These data also showed that the contraceptors had significantly more male partners than their contraceptive counterparts. Protective factors such as church attendance and family cohesiveness were associated with a decreased likelihood of sexual activity.
Fertility AwarenessFertile Window IdentificationPrimary Care Pregnancy AchievementNatural Fertility Indicator Effectiveness
Open Access
To determine the effectiveness of achieving pregnancy with focused intercourse in the fertile window identified using natural fertility indicators. 24-cycle prospective effectiveness study.
A North American web-based fertility monitoring service. 256 North American women aged 20-43 (mean age 29.2 years) seeking to achieve pregnancy. Participants identified their fertile window with either electronic hormonal fertility monitoring or cervical mucus monitoring, or both, and recorded their observations on an online fertility tracking system. Pregnancies were validated by nurses with an online self-assessed pregnancy evaluation form. Survival analysis was used to determine pregnancy rates. There were 150 pregnancies among the 256 participants with an overall pregnancy rate of 78 per 100 women over 12 menstrual cycles. There were 54 pregnancies (68%) among the 80 women using the fertility monitor, 11 pregnancies (46%) among the 24 women using mucus monitoring, and 90 (63%) among the 143 women using both mucus and monitor. The 12-cycle pregnancy rates per 100 women were 83 (monitor group), 72 (mucus group), and 75 (mucus and monitor group). Pregnancy rates reached 100% at 24 cycles of use for those women using the hormonal fertility monitor. Use of the hormonal fertility monitor alone seems to offer the best natural estimate of the fertile phase of the menstrual cycle for women wishing to achieve a pregnancy. Focusing intercourse through 24 menstrual cycles can be beneficial for achieving pregnancy.
Fertility AwarenessSelf-Tracking App Ovulation AnalysisApp-Based Population DataMobile App Menstrual Cycle Protocols
Open Access
There are many mobile phone apps aimed at helping women map their ovulation and menstrual cycles and facilitating successful conception (or avoiding pregnancy). These apps usually ask users to input various biological features and have accumulated the menstrual cycle data of a vast number of women. The purpose of our study was to clarify how the data obtained from a self-tracking health app for female mobile phone users can be used to improve the accuracy of prediction of the date of next ovulation. Using the data of 7043 women who had reliable menstrual and ovulation records out of 8,000,000 users of a mobile phone app of a health care service, we analyzed the relationship between the menstrual cycle length, follicular phase length, and luteal phase length. Then we fitted a linear function to the relationship between the length of the menstrual cycle and timing of ovulation and compared it with the existing calendar-based methods. The correlation between the length of the menstrual cycle and the length of the follicular phase was stronger than the correlation between the length of the menstrual cycle and the length of the luteal phase, and there was a positive correlation between the lengths of past and future menstrual cycles. A strong positive correlation was also found between the mean length of past cycles and the length of the follicular phase. The correlation between the mean cycle length and the luteal phase length was also statistically significant. In most of the subjects, our method (ie, the calendar-based method based on the optimized function) outperformed the Ogino method of predicting the next ovulation date. Our method also outperformed the ovulation date prediction method that assumes the middle day of a mean menstrual cycle as the date of the next ovulation. The large number of subjects allowed us to capture the relationships between the lengths of the menstrual cycle, follicular phase, and luteal phase in more detail than previous studies. We then demonstrated how the present calendar methods could be improved by the better grouping of women. This study suggested that even without integrating various biological metrics, the dataset collected by a self-tracking app can be used to develop formulas that predict the ovulation day when the data are aggregated. Because the method that we developed requires data only on the first day of menstruation, it would be the best option for couples during the early stages of their attempt to have a baby or for those who want to avoid the cost associated with other methods. Moreover, the result will be the baseline for more advanced methods that integrate other biological metrics.
Fertility AwarenessWrist Wearable Temperature MonitoringContinuous Temperature TrackingOvulation Detection Validation
Open Access
Core and peripheral body temperatures are affected by changes in reproductive hormones during the menstrual cycle. Women worldwide use the basal body temperature (BBT) method to aid and prevent conception. However, prior research suggests that taking one's daily temperature can prove inconvenient and subject to environmental factors. We investigate whether a more automatic, non-invasive temperature measurement system can detect changes in temperature across the menstrual cycle. We examined how wrist skin temperature (WST), measured with wearable sensors, correlates with urinary tests of ovulation and may serve as a new method of fertility tracking. One hundred and thirty-six eumenorrheic, non-pregnant women participated in an observational study. Participants wore WST biosensors during sleep and reported their daily activities. An at-home luteinizing hormone (LH) test was used to confirm ovulation. WST was recorded across 437 cycles (mean cycles/participant = 3.21, S.D. = 2.25). We tested the relationship between the fertile window and WST temperature shifts, using the BBT three-over-six rule. A sustained 3-day temperature shift was observed in 357/437 cycles (82%), with the lowest cycle temperature occurring in the fertile window 41% of the time. Most temporal shifts (307/357, 86%) occurred on ovulation day (OV) or later. The average early-luteal phase temperature was 0.33°C higher than in the fertile window. Menstrual cycle changes in WST were impervious to lifestyle factors, like having sex, alcohol, or eating prior to bed, that, in prior work, have been shown to obfuscate BBT readings. Although currently costlier than BBT, the present study suggests that WST could be a promising, convenient parameter for future multiparameter fertility awareness methods.
Fertility AwarenessComparison with Hormonal MethodsOral ContraceptivesSORT Criteria
Background and PurposePublished reports indicate that over 100 million women worldwide use the birth control pill (Oral Contraceptives, or OCPs).1,2 However, in a national study conducted by the Battelle Centers for Public Health Research and Evaluation, rates of discontinuation of some birth control methods were as high as 90%, and had averages between 40-61% (depending on marital status) for women who were followed over a two-year period.3 This suggests that women are searching for new methods, perhaps with fewer side effects or better effectiveness rates. Studies show up to 60% of women would be interested in using Fertility Awareness Based Methods (FABMs) if given information.4 Both FABMs and OCPs entail behavior modification on a daily basis, so the efficacy and side effects of FABMs and OCPs were chosen for comparison during this study.Most commonly reported unintended pregnancy rates for FABMs and OCPs are based on low quality retrospective surveys. A popularly cited review from J. R. Trussell and colleagues reports typical use failure rates of 24% for FABMs and 9% for OCPs.5 These numbers are based on estimates of the probability of pregnancy drawn from the 1995 and 2002 National Surveys of Family Growth.5'6 There are at least three major problems with these surveys. One is that these are lower quality retrospective surveys based primarily on patient recall, with the data collected via a series of phone surveys. Another major problem is that 86% of the purported FABM users surveyed identified the calendar method-a much older and less effective method-as their primary form of contraception. Then, the rates for all types of FABMs were pooled together, including some methods which are not even classified as FABMs by trained providers. This lumping together of all FABMs including rhythm masks important differences in effectiveness among the variety of modern methods; a fact acknowledged by Trussell, the author of this estimate.7'8'9 The third major issue with this review is that the rates of effectiveness were adjusted to account for the researchers' assumption of underreporting of abortion. As a result of the issues with these popularly cited statistics, we sought to design objective criteria with which to evaluate the primary literature available for FABMs and OCPs, in order to understand both the quality of the studies available as well as the true effectiveness rates. In total, three major search engines (Medline, PubMed, and EMBASE) were used with keyword searches to identify relevant articles. For FABMs, 30 articles from 1980 on were included in the study.6 For OCPs, 47 articles from 2000 on were included in the study. (The year 2000 was chosen in part because studies from earlier decades had used higher dose hormone formulations which were proven to be unsafe for women, and the trend in later years has been towards seeking lower dose hormonal formulations to provide the same efficacy with fewer side effects1). Strength of Recommendation Taxonomy (SORT) criteria10 were established first for the FABM review6 and then adapted for the OCP review (Adapted SORT). The adaptation was based on fundamental differences between FABMs and OCPs such as lack of a learning phase for OCPs. The purpose of the SORT and Adapted SORT criteria was to provide a framework to determine the level of evidence for individual studies.Two independent reviewers scored each of the identified articles for the FABMs and the OCPs reviewed. Major discrepancies in scores were resolved by sending the articles in question to a third reviewer for a tie-break score. For the FABMs reviewed, there were 56 maximum possible points with the SORT criteria. The scores ranged from 31-55 points, and 10 of the 30 articles (30%) were found to earn a SORT Level 1 status (qualified by earning a positive score in all of the critical criteria).6For the OCPs reviewed, there were 42 maximum possible points with the Adapted SORT criteria. …
RRM MethodsCEIBA Study Enrollment and MotivationsNFP Couple IntentionsCreighton Model Effectiveness Study
Open Access
The Creighton Model FertilityCare(TM) System (CrM) is a standardized approach for educating women about the biomarkers of their fertility. Couples can use this information for timing intercourse during "fertile" or "infertile" days in order to try to conceive or to avoid pregnancy. The study of Creighton Model Effectiveness, Intentions, and Behaviors Assessment (CEIBA) was conducted to assess fertility motivations, intentions, fertility-related sexual behaviors, and their impact on effectiveness to avoid and to conceive among new users of the CrM. This paper reports enrollment baseline characteristics. We conducted this prospective cohort study at 17 CrM FertilityCare(TM) Centers; 16 in the USA and one in Toronto, Canada. Couples who were new or returning users of the CrM were eligible. Couples who were initially trying to conceive or had a history of subfertility were excluded. Couples were enrolled and followed prospectively by their CrM instructors and also by CEIBA study staff. They completed baseline questionnaires. 1,132 new couples were assessed; 1,090 (96%) couples were screened; 429 (39%) couples were eligible; 305 women (71%) and 290 (95%) male partners were enrolled. The majority of women was engaged (39%) or married (51%), college graduates (77%), Caucasian non-Hispanic (80%), and Roman Catholic (80%). The most common reasons for learning CrM (women) were to use a natural method for family planning (91%), for moral/ethical/religious reasons (70%), the lack of side effects (71%), or insight into the menstrual cycle and fertility (62%). Women and men intended to have a mean of three and two additional children, respectively. Of women, 21% intended to have a child within a year and 60% between 1 and 3 years. The mean positive childbearing motivation score was 3.3 for both women and men (range 1-4, with 4 being most positive). Couples beginning use of the CrM to avoid pregnancy have high levels of motivation, desire, and intention for future childbearing. The CEIBA study has prospective measures of desires, intentions, and sexual/fertility behaviors for up to 1 year. We will assess the impact of desires, intentions, and behaviors on the pregnancy rates among these couples.
Frank-Herrmann P et al., 2017·Eur J Contracept Reprod Health Care
Sir,Currently, a variety of start-up companies are developing mobile phone apps to track the menstrual cycle and the fertile window, for the use of women who are trying to conceive or trying to avo...
NaProTECHNOLOGYCulture of LifeResponsible ParenthoodCreighton Model System
Open Access
NaProTECHNOLOGY is a new field of medicine specializing in the promotion of human procreation. Its foundation is a teaching system called the Creighton Model Fertility Care System. It is based on the ability to observe and record biological biomarkers, enabling spouses to recognize and understand the naturally occurring cycle of fertility and infertility. The spouses can use their acquired knowledge both for achiving pregnancy and avoiding pregnancy. The system also enables them to broaden their knowledge to better understand sexuality and deepen their mutual love. It also plays an important role in diagnosing and treating reproductive health according to the natural cycle of women. NaProTECHNOLOGY is involved in building a "new culture of life" through integral concern for human fertility by restoring natural procreation and respecting the principles of responsible parenthood.
Fertility AwarenessMedical Student FABM Knowledge AssessmentFABM Curriculum GapPhysician Training in Natural Family Planning
Open Access
Traditional medical school curricula have not addressed fertility awareness-based methods (FABMs) of family planning. The objective of this study was to assess (1) 3-year medical students' knowledge of FABMs of family planning, (2) their confidence in utilizing that knowledge in patient care, and (3) to implement focused education on FABMs to improve knowledge and confidence. Third-year medical students at one institution in the United States were given a 10-question assessment at the beginning of their OB-GYN rotation. Two lectures about FABMs and their clinical applications were given during the rotation. Students were given the same questions at the end of the rotation. Each questionnaire consisted of eight questions to assess a student's knowledge of FABMs and two questions to assess the student's confidence in sharing and utilizing that information in a clinical setting. McNemar's test was used to analyze the data. Two hundred seventy-seven students completed a pretest questionnaire and 196 students completed the posttest questionnaire. Medical knowledge improved from an initial test score of 38.99% to final test score of 53.57% (p < 0.05). Confidence in sharing FABM information with patients (0 = very uncomfortable; 5 = very comfortable) improved from 1.51 to 3.00 (p < 0.05). Confidence in utilizing FABM to diagnose and treat gynecologic/reproductive problems (0 = not very confident and 5 = very confident) improved from 1.01 to 3.15 (p < 0.05). Medical schools may not include FABMs in OB-GYN curriculum; however, to patients, these methods remain a sought after and valid form of family planning. This study shows that brief, focused education can increase medical students' knowledge of and confidence with FABMs of family planning.
Fehring RJ et al., 2017·J Obstet Gynecol Neonatal Nurs
To analyze the effectiveness of an online, nurse-managed natural family planning (NFP) program among breastfeeding women and subgroups of these women.
Longitudinal comparative cohort study.
A university-based online NFP education program and menstrual cycle charting system. Women (N = 816) with a mean age of 30.3 years (standard deviation = 4.5) who registered to use the online NFP system and indicated they were breastfeeding. Participants tracked their fertile times with an electronic hormone fertility monitor (EHFM), cervical mucus monitoring, or both. All unintended pregnancies were evaluated by professional nurses. The correct use pregnancy rates were 3 per 100 users over 12 cycles of use, and typical rates were 14 per 100 at 12 cycles of use. At 12 cycles of use, total pregnancy rates were 16 per 100 for electronic hormone fertility monitor users (n = 380), 81 per 100 among mucus-only users (n = 45), and 14 per 100 for electronic hormone fertility monitor plus mucus users (n = 391). Use of a nurse-managed online NFP program for women can be effective to help women avoid pregnancy while breastfeeding, especially with correct and consistent use.
Fertility AwarenessMenstrual CycleDiagnostics
Open Access
An affordable, user-friendly fertility-monitoring tool remains an unmet need. We examine in this study the correlation between pulse rate (PR) and the menstrual phases using wrist-worn PR sensors. 91 healthy, non-pregnant women, between 22-42 years old, were recruited for a prospective-observational clinical trial. Participants measured PR during sleep using wrist-worn bracelets with photoplethysmographic sensors. Ovulation day was estimated with "Clearblue Digital-Ovulation-urine test". Potential behavioral and nutritional confounders were collected daily. 274 ovulatory cycles were recorded from 91 eligible women, with a mean cycle length of 27.3 days (±2.7). We observed a significant increase in PR during the fertile window compared to the menstrual phase (2.1 beat-per-minute, p < 0.01). Moreover, PR during the mid-luteal phase was also significantly elevated compared to the fertile window (1.8 beat-per-minute, p < 0.01), and the menstrual phase (3.8 beat-per-minute, p < 0.01). PR increase in the ovulatory and mid-luteal phase was robust to adjustment for the collected confounders. There is a significant increase of the fertile-window PR (collected during sleep) compared to the menstrual phase. The aforementioned association was robust to the inter- and intra-person variability of menstrual-cycle length, behavioral, and nutritional profiles. Hence, PR monitoring using wearable sensors could be used as one parameter within a multi-parameter fertility awareness-based method.
Birth control is a persistent global health concern. Natural family planning (NFP) comprises methods to achieve or avoid pregnancy independent of mechanical or pharmacological intervention. The sympto-thermal method (STM) of NFP employs daily observation of cervical fluids and measurement of basal body temperature. This multi-country study was undertaken to describe the characteristics of STM users, understand their perceptions of NFP, and its perceived impact on relationships. Questionnaires for women and men were developed in German and translated to English, Polish, Italian, Czech, and Slovak by native speakers. A total of 2,560 respondents completed the online questionnaire (37.4% response). Participants were married (89%) and well educated, and their self-perceived financial status was described as "good" or "very good" by 65% of the respondents. Forty-seven percent had previously used contraceptives. Ninety-five percent of women and 55% of men said using NFP has helped them to know their body better. Large majorities of men (74%) and women (64%) felt NFP helped to improve their relationship while <10% felt use of NFP had harmed their relationship. Most women (53%) and men (63%) felt using NFP improved their sex life while 32% of women and 24% of men felt it was unchanged from before they used NFP. Seventy-five percent of women and 73% of men said they are either "satisfied" or "very satisfied" with their frequency of sexual intercourse. This survey demonstrates STM of NFP is a well-accepted approach to family planning across several Western cultures. It is consistently viewed as being beneficial to couples' self-knowledge, their relationship, and satisfaction with frequency of sexual intercourse.
Body LiteracyFertility Knowledge InterventionsYoung Adult AwarenessRandomized Controlled Trial
Conceição C et al., 2017·Eur J Contracept Reprod Health Care
Recent evidence has shown that young adults have poor knowledge about reproductive health and fertility, and that interventions are needed to increase fertility awareness. The aim of this study was to assess the effectiveness of a brief video in increasing knowledge about fertility and infertility in young adults. We carried out a two-arm, parallel-group, randomised controlled trial with a pre-test/post-test design (NCT02607761, ClinicalTrials.gov). The sample was composed of 173 undergraduates who completed a self-report questionnaire. Participants were randomly assigned to exposure or no exposure to an educational video about reproductive health and infertility (intervention group, n = 89; control group, n = 84). At baseline, participants revealed poor knowledge of infertility risk factors and fertility issues, and average knowledge of the definition of infertility. Interaction effects between group and time were found for all variables targeted in the video. Participants in the intervention group significantly increased their knowledge of fertility issues, infertility risk factors and the definition of infertility. No significant differences in post-test knowledge were observed in the control group, except for the age at which there is a marked decrease in female fertility. A short video intervention is effective in increasing short-term knowledge about reproductive health and infertility. If future research using longer intervals corroborates our findings, video intervention could be a useful tool in public health prevention campaigns.
Contraception/ComparisonFertility Awareness
Open Access
Sundaram A et al., 2017·Perspect Sex Reprod Health
Contraceptive failure rates measure a woman's probability of becoming pregnant while using a contraceptive. Information about these rates enables couples to make informed contraceptive choices. Failure rates were last estimated for 2002, and social and economic changes that have occurred since then necessitate a reestimation. To estimate failure rates for the most commonly used reversible methods in the United States, data from the 2006-2010 National Survey of Family Growth were used; some 15,728 contraceptive use intervals, contributed by 6,683 women, were analyzed. Data from the Guttmacher Institute's 2008 Abortion Patient Survey were used to adjust for abortion underreporting. Kaplan-Meier methods were used to estimate the associated single-decrement probability of failure by duration of use. Failure rates were compared with those from 1995 and 2002. Long-acting reversible contraceptives (the IUD and the implant) had the lowest failure rates of all methods (1%), while condoms and withdrawal carried the highest probabilities of failure (13% and 20%, respectively). However, the failure rate for the condom had declined significantly since 1995 (from 18%), as had the failure rate for all hormonal methods combined (from 8% to 6%). The failure rate for all reversible methods combined declined from 12% in 2002 to 10% in 2006-2010. These broad-based declines in failure rates reverse a long-term pattern of minimal change. Future research should explore what lies behind these trends, as well as possibilities for further improvements.
This Committee Opinion provides practitioners with suggestions for optimizing the likelihood of achieving pregnancy in couples/individuals attempting conception who have no evidence of infertility. This document replaces the document of the same name previously published in 2013, Fertil Steril 2013;100(3):631-7.
To analyze cumulative pregnancy rates of subfertile couples after fertility awareness training. A prospective observational cohort study followed 187 subfertile women, who had received training in self-observation of the fertile phase of the menstrual cycle with the Sensiplan method, for 8 months. The women, aged 21-47 years, had attempted to become pregnant for 3.5 years on average (range 1-8 years) before study entry. Amenorrhea, known tubal occlusion and severe male factor had been excluded. An additional seven women, who had initially been recruited, became pregnant during the cycle immediately this is taken to be the spontaneous pregnancy rate per cycle in the cohort in the absence of fertility awareness training. The cumulative pregnancy rate of subfertile couples after fertility awareness training was 38% (95% CI 27-49%; 58 pregnancies) after eight observation months, which is significantly higher than the estimated basic pregnancy rate of 21.6% in untrained couples in the same cohort. For couples who had been seeking to become pregnant for 1-2 years, the pregnancy rate increased to 56% after 8 months. A female age above 35 (cumulative pregnancy rate 25%, p = 0.06), couples who had attempted to become pregnant for more than 2 years (cumulative pregnancy rate 17%, p < 0.01), all significantly reduce the chances of conceiving naturally at some point. Training women to identify their fertile window in the menstrual cycle seems to be a reasonable first-line therapy in the management of subfertility.
Fertility AwarenessElectronic Fertility MonitoringTypical and Perfect UseOnline Programs
Fehring RJ et al., 2016·MCN Am J Matern Child Nurs
The aims of this study were to determine and compare extended use-effectiveness of an online nurse-managed fertility education service program among women (and subgroups of women) seeking to avoid pregnancy. This was a 24-month prospective study of a university-based online Web site with 663 nonbreastfeeding women using an online charting system to avoid pregnancy. Participants tracked their fertility online with either cervical mucus monitoring, electronic hormonal fertility monitoring, or both fertility indicators. Unintended pregnancies were validated by professional nurses. Participants had a mean age of 30.4 years (SD = 6.3) and mean 1.7 children (SD = 2.0). Among the 663 nonbreastfeeding participants there were 2 unintended pregnancies per 100 at 24 cycles of correct use and 15 pregnancies at 24 cycles of typical use. However, the 212 women using the electronic fertility monitor had a typical use unintended pregnancy rate of 6 at 24 cycles of use in comparison with the 118 women using cervical mucus monitoring that had a typical use pregnancy rate of 19 at 24 cycles and with the 333 women using both fertility indicators that had a pregnancy rate of 18 at 24 cycles of use. Use of the fertility monitor to estimate fertility among nonbreastfeeding women provides the most secure method of avoiding pregnancy.
Various fertility indicators are used by natural family planning methods to identify the fertile and infertile phases of a woman's mucus observations, cycle-day probabilities, basal body temperature readings, and hormonal measures of LH and estrogen. Simplified NFP methods generally make use of a single fertility indicator such as cycle-day probabilities (Standard Days Method) or mucus observations (Billings Ovulation Method). The Couple Bead Method integrates the two simplest fertility indicators, cycle-day probabilities and mucus observations, expanding its applicability to all women, regardless of cycle regularity and length. In determining cycle-day probabilities, the Couple Bead Method relies on a new data set from ultrasound-derived determinants of gestational age that more directly define the day of conception and the fertile window. By using a visual-based system of inexpensive colored beads, the Couple Bead Method can be used by couples of all educational and income levels. Natural family planning methods provide education in regard to the signs of a woman's body which indicate if she is possibly fertile or not. Two important signs are the day of her menstrual cycle and her observations of bleeding and cervical mucus or dryness. The Couple Bead Method teaches a couple how to observe these signs and chart them with a system of colored beads. The Couple Bead Method can be used by women with regular or irregular cycles. The bead sets are inexpensive and consist of a length of plastic cord, colored "pony beads" and safety pins.
In recent years there has been an explosion in the development of medical apps, with more than 40,000 apps now available. Nearly 100 apps allow women to track their fertility and menstrual cycles and can be used to avoid or achieve pregnancy. Apps offer a convenient way to track fertility biomarkers. However, only some use evidence-based fertility awareness-based methods (FABMs), which with ideal use have rates of effectiveness similar to those of commonly used forms of hormonal birth control. Since having a baby or preventing a pregnancy are important responsibilities, it is critical that women and couples have access to reliable, evidence-based apps that allow them to accurately track their fertility. We developed a tool to evaluate and rate fertility apps. This tool is specifically designed to help couples avoid pregnancy. Results showed that the majority of fertility apps are not based on evidence-based FABMs or include a disclaimer discouraging use for avoiding pregnancy. However, at least 1 app in each FABM category (except symptohormonal methods) had a perfect score on accuracy. Relying solely on an app to use an FABM, without appropriate training in the method, may not be sufficient to prevent pregnancy.
The aim of this study was to evaluate the association between menstrual cycle characteristics in early life and adulthood and fecundability. Pregnancy Study Online (PRESTO) is an Internet-based preconception cohort study of pregnancy planners from the United States and Canada. During the preconception period, we enrolled 2189 female pregnancy planners aged 21-45 years who had been attempting conception for ≤6 cycles. Women self-reported menstrual cycle characteristics via an online baseline questionnaire, and pregnancy status was ascertained through bimonthly follow-up questionnaires. Proportional probabilities models were used to estimate fecundability ratios (FRs) and 95% confidence intervals (CIs), adjusting for potential confounders. Compared with usual menstrual cycle lengths of 27-29 days, cycle lengths of <25 (FR = 0.81, 95% CI: 0.54-1.22) and 25-26 days (FR = 0.92, 95% CI: 0.75-1.14) were associated with reduced fecundability. Compared with women who reached menarche at the age of 12-13 years, those who reached menarche at <12 years had reduced fecundability (FR = 0.87, 95% CI: 0.76-0.99). Women whose cycles never regularized after menarche (FR = 0.93, 95% CI: 0.81-1.06) had slightly reduced fecundability compared with women whose cycles regularized within 2 years of menarche. Bleed length and heaviness of bleeding were not appreciably associated with fecundability. Menstrual cycle characteristics, specifically cycle length and age at menarche, may act as markers of fertility potential among pregnancy planners.
Fertility AwarenessResearch Methodology
Open Access
To examine transient environmental exposures and their relationship with human fecundity, exposure assessment should occur optimally at the time of conception in both members of the couple. We performed an observational, prospective cohort study with biomonitoring in both members of a heterosexual couple trying to conceive. Couples collected urine, saliva, and semen specimens for up to two menstrual cycles on days corresponding to the time windows of fertilization, implantation, and early pregnancy, identified based on the woman's observations of her cervical fluid. Three hundred nine eligible couples were screened between 2011 and 2015, of which 183 enrolled. Eleven couples (6.0 %) withdrew or were lost to follow up. The most successful and cost effective recruiting strategies were word of mouth (40 % of participating couples), posters and flyers (37 %), and targeted Facebook advertising (13 %) with an overall investment of $37.35 spent on recruitment per couple. Both men and women collected ≥97.2 % of requested saliva samples, and men collected ≥89.9 % of requested semen samples. Within the periovulatory days (±3 days), there was at least one urine specimen collected by women in 97.1 % of cycles, and at least one by men in 91.7 % of cycles. Daily compliance with periovulatory urine specimens ranged from 66.5 to 92.4 % for women and from 55.7 to 75.0 % for men. Compliance was ≥88 % for questionnaire completion at specified time points. Couples planning to conceive can be recruited successfully for periconceptional monitoring, and will comply with intensive study protocols involving home collection of biospecimens and questionnaire data.
Fertility AwarenessUrinary Hormone MonitoringBBT and Cervical Mucus ValidationPregnanediol Glucuronide Threshold
Do the basal body temperature (BBT) shift and the cervical mucus markers for the beginning of the post-ovulatory infertile phase (POIP) of a menstrual cycle agree with the corresponding urinary pregnanediol glucuronide (PdG) threshold value? Perfect agreement between the cervical mucus markers and BBT shift and the hormonal definition of the start of post-ovulatory infertility occurred for only 7-17% of the cycles. The PdG threshold of 7.0 µmol/24 h is an objective and accurate marker for the beginning of the POIP. The rise in serum progesterone also produces the BBT shift and changes in cervical mucus which determine the mucus peak. Serum progesterone and urinary PdG are closely correlated when variations in urine volume are taken into account. STUDY DESIGN, SIZE, Individual menstrual cycle profiles of urinary PdG excretion rates for 91 fertile cycles from normally cycling women were analysed to identify the day of the beginning of the POIP. These days were compared with those determined by the day of the BBT shift +2 days, the day of the mucus peak +4 days and the later of these two indicators. The study lasted 3 years. PARTICIPANTS/MATERIALS, SETTING, A total of 62 women with normal menstrual cycles were Palmerston North, New Zealand; Sydney, Australia and Santiago, Chile. The cycles were displayed individually in a proprietary database program which recorded the PdG excretion rates, the BBT shift day and the cervical mucus peak day. A group of 15 women from a separate Chilean study had PdG urinary data measured as well as their day of ovulation determined by ultrasound. MAIN The BBT and cervical mucus markers differed significantly in their identification of the beginning of the POIP when compared with the PdG excretion rate of 7.0 µmol/24 h. The observation that the BBT shift day and the mucus peak day could be identified even though the PdG excretion rates were still at baseline levels in some cycles could lead to an unexpected pregnancy for women using these natural family planning (NFP) indicators. LIMITATIONS, The study consisted only of fertile cycles from women with regular cycles of 20-40 days duration. All the women were intending to avoid a pregnancy during the study, thus the limits of the fertile window were not tested. The NFP signals occurring earlier than the PdG threshold day could lead to an unexpected pregnancy. The signals occurring on the same day or later than the PdG threshold would not lead to unexpected pregnancies, but would require extra abstinence that could lead to non-compliance with the NFP method. A possible improvement in reliability of NFP methods is suggested. This study (project #90905) was funded by the NDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP). D.G.C. currently works for a diagnostic development company, Science Haven Ltd. The other authors have nothing to declare.
Ovulatory menstrual cycles are essential for women's fertility and needed to prevent bone loss. There is a medical/cultural expectation that clinically normal menstrual cycles are inevitably ovulatory. Currently within the general population it is unknown the proportion of regular, normal-length menstrual cycles that are ovulatory. Thus, the objective of this study was to determine the population point prevalence of ovulation in premenopausal, normally menstruating women. The null hypothesis was that such cycles are ovulatory. This is a single-cycle, cross-sectional, population-based study-a sub-study of the HUNT3 health study in the semi-rural county (Nord Trøndelag) in mid-Norway. Participants included >3,700 spontaneously (no hormonal contraception) menstruating women, primarily Caucasian, ages 20-49.9 from that county. Participation rate was 51.9%. All reported the date previous flow started. A single, random serum progesterone level was considered ovulatory if ≥9.54 nmol/L on cycle days 14 to -3 days before usual cycle length (CL). Ovulation was assessed in 3,168 women mean age 41.7 (interquartile range, [IQR] 36.8 to 45.5), cycle length 28 days (d) (IQR 28 to 28) and body mass index (BMI) 26.3 kg/m2 (95% CI 26.1 to 26.4). Parity was 95.6%, 30% smoked, 61.3% exercised regularly and 18% were obese. 1,545 women with a serum progesterone level on cycle days 14 to -3 were presumed to be in the luteal phase. Of these, 63.3% of women had an ovulatory cycle (n = 978) and 37% (n = 567) were anovulatory. Women with/ without ovulation did not differ in age, BMI, cycle day, menarche age, cigarette use, physical activity, % obesity or self-reported health. There were minimal differences in parity (96.7% vs. 94.5%, P = 0.04) and major differences in progesterone level (24.5 vs. 3.8 nmol/L, P = 0.001). Anovulation in a random population occurs in over a third of clinically normal menstrual cycles.
The purpose of this study was to determine the influence of contraception, abortion, and natural family planning (NFP) on divorce rates of US women of reproductive age. The variables of importance of religion and frequency of church attendance were also included in the analysis. The study involved 5,530 reproductive age women in the (2006-2010) National Survey of Family Growth who indicate that they were ever married. Among the women who ever used NFP only 9.6 percent were currently divorced compared with the 14.4 percent who were currently divorced among the women who never used NFP (x (2) = 5.34, P < 0.21). Odds ratio analysis indicated that ever having an abortion, sterilization, and/or methods of contraception increased the likelihood of divorce - up to two times. Frequency of church attendance decreased the risk of divorce. Although there is less divorce among NFP users the reason might be due to their religiosity. Providers of natural family planning (NFP) frequently mention that couples who practice NFP have fewer divorces compared to couples who use contraception. Evidence for this comment is weak. This study utilized a large data set of 5,530 reproductive age women to determine the influence that contraception, sterilization, abortion, and NFP has on divorce rates. Among the women participants who ever used NFP only 9.6 percent were currently divorced compared with the 14.4 percent who used methods of contraception, sterilization or abortion as a family planning method. Frequency of church attendance also reduced the likelihood of divorce.
Fertility AwarenessMonitor vs MucusEstimation AccuracyFertility Monitor Protocol
The length of periodic abstinence, due to overestimation of the fertile phase of the menstrual cycle, is often a cause for dissatisfaction, discontinuation, and user error with natural family planning (NFP) methods. The objective of this research was to compare the length of required abstinence (ie, estimated fertility) and coital frequency between 2 NFP methods. This was an analysis of data from a 12-month prospective comparison study in which participants were randomized into either an electronic hormonal fertility monitor (EHFM) group or a cervical mucus monitoring (CMM) group-both of which included a fertility algorithm as a double check for the beginning and end of the estimated fertile window. The number of days of estimated fertility and coitus was extracted from each menstrual cycle of data, and t tests were used to compare the means of these 2 variables between the 2 NFP methods. The study involved 197 women (mean [SD] age 29.7 [5.4]) who used the EHFM to estimate the fertile window and 160 women (mean [SD] age 30.4 [5.3]) who used CMM to estimate the fertile window. They produced 1,669 menstrual cycles of data. After 12 months of use, the EHFM group had statistically fewer days of estimated fertility than the CMM group (mean [SD] days, 13.25 [2.79] vs 13.68 [2.99], respectively; t = 2.07; P = .039) and significantly more coitus (mean [SD] coital acts, 4.22 [3.16] vs 4.05 [2.88], respectively; t = 1.17; P = .026). The use of the EHFM seems to provide more objectivity and confidence in self-estimating the fertile window and using nonfertile days for intercourse when avoiding pregnancy.
Ovulation occurs on 1 day during each menstrual cycle (even if multiple follicles are involved), and the several days preceding ovulation are when intercourse is most likely to result in pregnancy. Collectively, the potentially fertile days up to and including the day of ovulation are called the “fertile window” (1). Since the 1930s, several biomarkers of the fertile window have been investigated for the purposes of empowering women and couples seeking to use fertility-awareness based methods or natural family planning to avoid pregnancy, as well as to expand understanding of human reproductive physiology.
Fertility AwarenessFertile Window DetectionCervical Mucus PatternsUltrasound Validation of Biomarkers
To assess the sensitivity and specificity of the self-identified fertile window. Observational study. Not applicable. PATIENT(S): A total of 107 women. INTERVENTION(S): Women recorded cervical mucus observation and basal body temperature daily while undergoing daily ovarian ultrasound. MAIN OUTCOME MEASURE(S): The biological fertile window, defined as the 6 days up to and including the day of ovulation; and the 2-day ovulation window, defined as the day before and the day of ovulation. RESULT(S): The self-identification of the biological fertile window by the observation of any type of cervical mucus provides 100% sensitivity but poor specificity, yielding a clinical fertile window of 11 days. However, the identification of the biological fertile window by peak mucus (defined as clear, slippery, or stretchy mucus related to estrogen) yielded 96% sensitivity and improved specificity. The appearance of the peak mucus preceded the biological fertile window in less than 10% of the cycles. Likewise, this type of mucus identified the ovulation window with 88% sensitivity. CONCLUSION(S): These results suggest that, when perceived accurately, more accurate clinical self-detection of the fertile window can be obtained by identification of peak mucus. This may improve efforts to focus intercourse in the fertile phase for couples with fertility concerns.
There has been much debate regarding levonorgestrel emergency contraception's (LNG-EC's) method of action since 1999 when the Food and Drug Administration first approved its use. Proponents of LNG-EC have argued that they have moral certitude that LNG-EC works via a non-abortifacient mechanism of action, and claim that all the major scientific and medical data consistently support this hypothesis. However, newer medical data serve to undermine the consistency of the non-abortifacient hypothesis and instead support the hypothesis that preovulatory administration of LNG-EC has significant potential to work via abortion. The implications of the newer data have important ramifications for medical personnel, patients, and both Catholic and non-Catholic emergency room protocols. In the future, technology such as the use of early pregnancy factor may have the potential to quantify how frequently preovulatory LNG-EC works via abortion. How Plan B (levonorgestrel emergency contraception) works has been vigorously debated ever since the Food and Drug Administration approved it in 1999. Many doctors and researchers claim that it has either no-or at most-an extremely small chance of working via abortion. However, the latest scientific and medical evidence now demonstrates that levonorgestrel emergency contraception theoretically works via abortion quite often. The implications of the newer data have important ramifications for medical personnel, patients, and both Catholic and non-Catholic emergency room rape protocols.
Fertility awareness based methods (FABMs) can be used to ameliorate the likelihood to conceive. A literature search was performed to evaluate the relationship of cervical mucus monitoring (CMM) and the day-specific -pregnancy rate, in case of subfertility. A MEDLINE search revealed a total of 3331 articles. After excluding articles based on their relevance, 10 studies and were selected. The observed studies demonstrated that the cervical mucus monitoring (CMM) can identify the days with the highest pregnancy rate. According to the literature, the quality of the vaginal discharge correlates well with the cycle-specific probability of pregnancy in normally fertile couples but less in subfertile couples. The results indicate an urgent need for more prospective randomised trials and -prospective cohort studies on CMM in a subfertile population to evaluate the effectiveness of CMM in the subfertile couple.
By encouraging doctors and scientists to improve the regulation of births through the observation of natural fertility rhythms, Humanae vitae promoted the development of natural family planning (NFP). The study of NFP has lead to NFP-based methodologies in reproductive healthcare that are promoting advances in treatment of infertility, miscarriage, and a number of reproductive health disorders. In contrast, the contraceptive mentality has stunted the development of reproductive healthcare. Humanae vitae has provided a great gift to science and reproductive healthcare that all Catholics should be proud of.
BillingsMentor is an automated Web-based service for the Billings Method of natural family planning in which the guidance and interpretation previously communicated from teacher to student is provided by programmed algorithms. (1) to instruct the client to generate proper descriptions of her fertility symptoms; and (2) to interpret the symptoms efficiently according to the Billings Method and to communicate the results to the client. The efficiency of billingsMentor was tested by using the historical records of students who were under the guidance of a teacher to emulate their experience under the guidance of billingsMentor. The results indicate that billingsMentor performs as well as the teacher/student in recognizing the peak of fertility but it is slightly less efficient than the teacher/student in establishing the basic infertile pattern. Advantages that arise from adapting natural family planning to information technology are discussed.
The Creighton Model FertilityCare System (CrMS) teaches women to identify days when intercourse is likely to result in pregnancy. We sought to assess the impact of the CrMS on time to pregnancy (TTP), via per-cycle pregnancy rates (fecundability). We conducted a parallel randomised trial at the University of Utah School of Medicine, 2003-06. Women ages 18-35 years, in a relationship of proven fertility, who desired to conceive, were block-randomised and stratified for age, with allocation concealment by opaque sequentially numbered sealed envelopes. The control group received the advice to have intercourse 2-3 times per week, and the intervention group received CrMS instruction. All women were asked to begin trying to conceive starting the second cycle in the study and were followed actively up to seven cycles, without blinding of research personnel. We calculated descriptive statistics and fecundability, and estimated Cox models for TTP. (Clinicaltrials.gov NCT00161395). There were 143 71 to the control group (all analysed) and 72 to the CrMS group (69 analysed). The adjusted hazard ratio for the influence of CrMS on TTP was 0.86 [95% confidence interval (CI): 0.53, 1.38]. Fecundability in cycles with intent to conceive was 31% in controls and 36% with CrMS (P = 0.32). By the first cycle, fecundability was 17% in controls, and 4% with CrMS (P = 0.02). No adverse events were reported. We found no significant impact of CrMS on TTP or fecundability, but fewer of the women receiving CrMS conceived by the first cycle.
To compare previously used algorithms to identify anovulatory menstrual cycles in women self-reporting regular menses.
Prospective cohort study.
Western New York. PATIENT(S): Two hundred fifty-nine healthy, regularly menstruating women followed for one (n=9) or two (n=250) menstrual cycles (2005-2007). INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Prevalence of sporadic anovulatory cycles identified using 11 previously defined algorithms that use E2, P, and LH concentrations. RESULT(S): Algorithms based on serum LH, E2, and P levels detected a prevalence of anovulation across the study period of 5.5%-12.8% (concordant classification for 91.7%-97.4% of cycles). The prevalence of anovulatory cycles varied from 3.4% to 18.6% using algorithms based on urinary LH alone or with the primary E2 metabolite, estrone-3-glucuronide, levels. CONCLUSION(S): The prevalence of anovulatory cycles among healthy women varied by algorithm. Mid-cycle LH surge urine-based algorithms used in over-the-counter fertility monitors tended to classify a higher proportion of anovulatory cycles compared with luteal-phase P serum-based algorithms. Our study demonstrates that algorithms based on the LH surge, or in conjunction with estrone-3-glucuronide, potentially estimate a higher percentage of anovulatory episodes. Addition of measurements of postovulatory serum P or urine pregnanediol may aid in detecting ovulation.
Fertility AwarenessSperm-Mucus InteractionLLETZ and FertilityCervical Mucus Physiology
Knowledge regarding the role of the cervix in fertility has expanded considerably over the past 20 years and in this article, we propose that it is now time for its function to be reappraised. First, we review the anatomy of the cervix and the vaginal ecosystem that it inhabits. Then, we examine the physiology and the role of the cervical mucus. The ongoing mystery of the exact mechanism of the sperm-cervical mucus interaction is reviewed and the key players that may unlock this mystery in the future are discussed. The soluble and cellular biomarkers of the lower female genital tract which are slowly being defined by contemporary research are reviewed. Attempts to standardize these markers, in this milieu, are hindered by the changes that may be attributed to endogenous age, hormonal changes during the menstrual cycle, ectropion, infection, smoking and exposure to semen during sexual intercourse. We review what is known about the immunology of the cervix. With the widespread use of large loop excision of the transformation zone (LLETZ) for treatment of cervical intraepithelial neoplasia, the anatomy of the cervix is changing for many women. While LLETZ surgery has had very positive effects in the fight against cervical cancer, we debate the impact it could have on a woman's fertility.
The Ethical and Religious Directives for Catholic Health Care Services allows the use of an emergency contraceptive for a woman who has been raped, as a defense against her attacker's sperm, provided the drug prevents fertilization and does not act against a conceived human life. Catholic emergency rooms around the country have been pressured to provide Plan B (LNG-EC) to patients seeking help after a sexual assault. Catholic bioethicists have supported the use of this drug based on their interpretation of the scientific literature regarding its mechanism of action. This paper presents a review of the mechanisms of action of LNG-EC when given during the fertile window, showing a high probability that it acts against human life rather than preventing fertilization, and proposes another class of drugs as a possible alternative.
Fertility AwarenessOvulation Predictor KitsAdjunct Tools for Cycle MonitoringCrossover Design
Difficult clinical signs such as confusing cervical mucus or erratic basal body temperature can make the use of fertility awareness methods (FAMs) difficult in some cases. The goal of this study was to assess the feasibility of using a cheap urinary luteinizing hormone (LH)-surge identification kit as an adjunct to identify the infertile phase after ovulation when facing these scenarios. The study used a block-allocation, crossover, 2-arm methodology (LH kit/FAM vs FAM only). Comparison of the 2 arms was done with regard to the accuracy of identification (yes/no) of the luteal phase in each cycle as confirmed by serum progesterone concentrations. We recruited 23 Canadian women currently using FAM, aged 18 to 48 years, who have had menstrual cycles 25 to 35 days long for the past 3 months and perceive themselves to have difficulty with identifying the infertile phase after ovulation. LH kits identified 100% of the luteal phases, whereas FAM indentified 87% (statistically significant). In those identified cycles, LH kits provided a mean of 10.3 days of infertility, and FAM only provided 10 days of infertility (not statistically significant). Among this population, LH kits may offer an adjunct for women who may wish to have an additional double-check. However, there are still clinical circumstances when even an LH kit does not provide confirmation. More research in this area is encouraged.
Fertility AwarenessPerimenopause UseNatural Family PlanningSurvival Analysis
Fehring RJ et al., 2014·J Obstet Gynecol Neonatal Nurs
To determine the efficacy of using natural family planning (NFP) methods to avoid unintended pregnancy among women of perimenopause age (i.e., age 40-55 years).
A secondary analysis of subset data from two prospective observational cohort studies.
A university based in-person and online NFP service program. One hundred and sixty couples who used either a website or an in-person NFP service to learn how to avoid pregnancy from January 2001 to November 2012. A prospective 12-month effectiveness study among 160 women (between ages 40-55) who used NFP to avoid pregnancy. The women used either a hormonal fertility monitor, cervical mucus monitoring, or both to estimate the fertile phase of their menstrual cycles. Survival analysis was used to determine the pregnancy rate over 12 months of use. There were a total of five unintended pregnancies among the participants. The typical use pregnancy rate was six per 100 women over 12 months. The monitor alone participants (n = 35) had a 12-month pregnancy rate of three, the participants (n = 73) who used mucus alone had a pregnancy rate of four, and the participants (n = 42) who used the fertility monitor plus mucus had a pregnancy rate of six. Natural family planning methods can be effective for older women to avoid an unintended pregnancy with correct use and adequate instructions. The pregnancy rate most likely was affected by diminished fertility and motivation to limit family size.
Fertility AwarenessDiagnosticsMenstrual Cycle
Open Access
Transient exposures may influence fertility and early embryonic development. To assess the time of conception in vivo and conduct concurrent biomonitoring, ovulation must be identified prospectively. We report on the development and validation of a simple, prospective method, the Peak Day method, to determine likely day of ovulation based upon daily observations of cervical fluid. We recruited 98 women to learn the Peak Day method from a brochure, 26 of whom concurrently used the method with blinded daily urine hormone monitoring (estrone glucuronide and luteinizing hormone). All women were instructed to complete an exposure questionnaire immediately upon identifying ovulation. Briefly, the exposure questionnaire captured time-varying and transient exposures such as medication use, water consumption, and amount of sleep. We assessed timely completion of the exposure questionnaire, agreement of women's estimated day of ovulation (EDO) and the EDO by expert review, and agreement between the EDO by expert review and by blinded urine monitoring. Of 147 cycles evaluated, women selected an EDO in 130 (88%) and subsequently completed the periovulatory exposure questionnaire in 122 (94%) cycles. Of the 26 cycles evaluated with blinded hormonal monitoring, the Peak Day "best quality" algorithm, based upon cervical fluid, identified ovulation ± 3 days of the urine monitor in 24 cycles (92%). With simple written instructions, women can identify an estimated day of ovulation and perform periovulatory exposure assessment. The Peak Day method is highly cost-effective and could be applied by researchers to target periconceptional or very early developmental stage exposure assessment.
To compare pregnancy rates when women have intercourse on self-estimated high and peak fertile days and when they only have intercourse on low fertile days during the fertile window (FW). We used a prospective observational cohort study design. Our convenience sample included 124 women who utilized our online charting Web sites to achieve pregnancy from January 2010 to November 2012. Participants used an electronic hormonal fertility monitor (EHFM) or self-observed cervical mucus or both to determine fertility during the estimated FW. Pregnancy rates were determined with Kaplan-Meier survival analysis. Chi square analysis was used to evaluate the efficacy of achieving pregnancy between two different intercourse patterns. The pregnancy rate was 87 per 100 women at 12 months when intercourse happened on high or peak days and 5 per 100 when intercourse occurred only on low days of the FW. Chi square analysis showed a greater proportion of pregnancies with intercourse on high and peak fertile days of the menstrual cycle (x2 = 40.2, p < .001, df = 1). Focusing intercourse on high or peak fertile days during the estimated FW enhances the probability of achieving a desired pregnancy. Fertility awareness-based online charting system is effective in helping women to determine their FW and target intercourse accordingly to achieve pregnancy.
What are the characteristics of, and how variable are, individual normal menstrual cycle profiles of excretion rates for the urinary metabolites oestrone glucuronide (E1G) and pregnanediol glucuronide (PdG)? There is a continuum of menstrual cycle profiles that differ from standard textbook profiles but which can be understood simply in terms of growth, atresia and ovulation of ovarian follicles. Point-of-care assays with the Ovarian Monitor pre-coated assay tubes, using urine samples diluted to a constant volume per unit time, give laboratory accurate clinical data for individual menstrual cycles. Lay operators can perform the point-of-care assay system at home to achieve reliable and reproducible results, which can be used for natural family planning. STUDY DESIGN, SIZE, This prospective study involved 62 women, with normal menstrual cycles, Palmerston North, New Zealand, Sydney, Australia and Santiago, Chile. The study lasted 3 years. PARTICIPANTS/MATERIALS, SETTING, Women collected daily urine samples and determined their E1G and PdG rates with a pre-coated enzyme assay system known as the Ovarian Monitor. For two cycles, the assays were repeated in a study centre and the results were averaged to give 113 individual menstrual cycles for analysis. The cycles were displayed individually in a proprietary database program. MAIN The individual normal hormonal profiles were more complex than the classic composite curves for 40% of the cycles. Of 113 ostensibly normal cycles, only 91 were potentially fertile and 22 had some luteal phase defect. The oestrone glucuronide and PdG excretion rates were reliable and informative in the non-invasive elucidation of ovulation and ovarian function for both simple and complex profiles. Daily monitoring revealed the variability of normal menstrual cycle profiles. The LH peaks were variable and ambiguous markers for ovulation. LIMITATIONS, The study consisted of cycles only from women with regular cycles of 20-40 days duration. All the women were intending to avoid a pregnancy during the study thus the limits of the fertile window were not tested. The principles established in this study should apply to cycles of any length. All peaks in oestrone glucuronide excretion should be tested by concurrent measurements of PdG, which gives a positive indication of the fate of the follicle it represents. The Ovarian Monitor provides a useful addition for practitioners of natural family planning. STUDY FUNDING/COMPETING INTEREST(S): Financial support for this study was obtained from the UNDP/UNFPA/World Bank/WHO Special Programme of Research, Development and Research Training in Human Reproduction (HRP). D.G.C. is currently employed by and holds stock in Manawatu Diagnostics Ltd, a company in the development phase of a potentially competing product. The remaining authors have nothing to declare.
Fehring RJ et al., 2013·MCN Am J Matern Child Nurs
To determine the influence of mutual motivation on unintended pregnancy rates of couples who used natural family planning (NFP) methods to avoid pregnancy. Using an online taught NFP method, 358 women and (their male partners) indicated "how much" and "how hard" they wished to avoid pregnancy on a scale of 0 to 10 before each menstrual cycle charted over 12 month of use. This motivation scale is used in the National Survey of Family Growth as a measure of motivation. All pregnancies were verified with an online pregnancy evaluation and urine-based pregnancy test. A combined motivation score was used in analysis. There were 28 pregnancies among the low-motivation participants (N = 60) and 16 among the high-motivation participants (N = 298). At 12 months of use, there were 75 pregnancies per 100 users for the low-motivation group and only 8 for the high-motivation group. There was an 80% greater likelihood of a pregnancy with the low-motivation group (χ = 25.5, p < .001, odds ratio = 1.80; 95% confidence interval = 1.61-1.90).
High motivation to avoid pregnancy by both the female user of a behavioral method of family planning and her male partner is required for high efficacy. Assessing motivation of both the woman and her male partner before prescribing NFP methods is recommended.
Urinary hormonal markers may assist in increasing the efficacy of Fertility Awareness Based Methods (FABM). This study uses urinary pregnanediol-3a-glucuronide (PDG) testing to more accurately identify the infertile phase of the menstrual cycle in the setting of FABM. Secondary analysis of an observational and simulation study, multicentre, European study. The study includes 107 women and tracks daily first morning urine (FMU), observed the changes in cervical mucus discharge, and ultrasonography to identify the day of ovulation over 326 menstrual cycles. The following (A) use of the daily pregnandiol-3a-glucuronide (PDG) test alone; (B) use of the PDG test after the first positive urine luteinizing hormone (LH) kit result; (C) use of the PDG test after the disappearance of fertile type mucus. (1) one day of PDG positivity; or (2) waiting for three days of PDG positivity before declaring infertility. After the first positivity of a LH test or the end of fertile mucus, three consecutive days of PDG testing over a threshold of 5μg/mL resulted in a 100% specificity for ovulation confirmation. They were respectively associated an identification of an average of 6.1 and 7.6 recognized infertile days. The results demonstrate a clinical scenario with 100% specificity for ovulation confirmation and provide the theoretical background for a future development of a competitive lateral flow assay for the detection of PDG in the urine.
There are few studies that have investigated the spiritual problems of couples practicing natural family planning (NFP). The purpose of this paper is to analyze the spiritual problems and interventions of couples who were taught NFP by means of a professional online Web-based support system. Responses from this online system and its forums were categorized according to spiritual responses, spiritual problems, and spiritual interventions to the practice of NFP. Themes addressed included spiritual care in regards to decisions about the transmission of new life, difficulties in dealing with chastity and abstinence, bioethical problems related to pregnancy and illness, end of the reproductive life decisions, ethical treatment of women's health problems, sacrifice, and personal and relational struggles. Online community support, help in building confidence in NFP methods, and bioethicist referral are key interventions. The complexity of these spiritual responses, problems, and appropriate interventions require the expertise of health professionals in cooperation with bioethicists. We concluded that NFP can be viewed as both a spiritual practice and a means of spiritual growth.
To assess the use of cervical mucus monitoring (CMM) in women trying to conceive and determine whether monitoring is associated with increased cycle-specific probability of conception (fecundability). Time-to-pregnancy cohort study. Population-based cohort. PATIENT(S): Three hundred thirty-one women trying to conceive, ages 30 to 44 years, without known infertility. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): CMM prevalence and fecundability. RESULT(S): During the first cycle of the study, CMM was performed consistently (checked on >66% of pertinent cycle days) by 20 women (6%), inconsistently (34% to 66% of days) by 60 women (18%), infrequently (≤33% of days) by 73 women (22%), and not performed by 178 women (54%). Cycles in which CMM was consistently performed were statistically significantly more likely to result in conception after adjusting for age, race, previous pregnancy, body mass index, intercourse frequency, and urinary luteinizing hormone (LH) monitoring. Fecundability also increased with increasing consistency of CMM. CONCLUSION(S): Among women trying to conceive, CMM is uncommon, but our study suggests that CMM-a free, self-directed method to determine the fertile window-is associated with increased fecundability independent of intercourse frequency or use of urinary LH monitoring.
InfertilityTreatment Utilization PatternsOvulation MonitoringTiming and Appropriateness
The purpose of this study was to compare the utilization of medical help for fertility among women who reported up to a year versus more than a year of trying to become pregnant and to describe the characteristics of those women seeking early treatment. Data from the 2004-2008 Pregnancy Risk Assessment Monitoring System (PRAMS) survey were used to assess attempt duration and use of fertility treatments in a sample of 9,517 women who had a recent live birth in Utah. PRAMS respondents who were trying to become pregnant at the time of conception were asked questions about fertility treatments (sampling n = 5,238; representative n = 153,036). Univariate and bivariate analyses were used to describe and compare characteristics of women who sought treatment after attempting pregnancy for a year or less and women who waited at least a year to seek treatment. Among women who were trying to become pregnant, 9.5 % reported using some medical assistance to conceive. Among the women trying to become pregnant, 89.3 % had been trying for ≤12 months and 10.7 % reported having tried >12 months. 5.2 % of those trying to become pregnant for up to a year reported use of fertility treatment, compared with 45.8 % of those trying for a year or more. Women who had previous live births were significantly more likely to use early treatment than nulliparous women (aOR = 2.4, 95 % CI = 1.5, 3.9). The use of fertility drugs and other treatments were more common than ART among recipients of early treatment (aOR = 3.7, 95 % CI = 1.7, 7.9). Some women may be receiving fertility treatment before it is clinically indicated. Instead of invasive treatment, these women may benefit from preconception counseling on folic acid, healthy prepregnancy weight and use of ovulation monitoring to time intercourse.
As the editor of the Anscombe Bioethics Centre's Issues in Reproductive and Sexual Ethics (Watt 2011), I was delighted to read Sr. Renee Mirkes’ generous review in th...
Fertility AwarenessPostpartum ProtocolsReturn of FertilityPregnancy Avoidance Rates
The postpartum period is a challenging time for family planning, especially for women who breastfeed. Breastfeeding delays the return of menses (lactational amenorrhea), but ovulation often occurs before first menses. For this reason, a protocol was developed to assist women in identifying their return of fertility postpartum to avoid pregnancy. In this prospective, 12-month, longitudinal cohort study, 198 postpartum women aged 20 to 45 years (mean age, 30.2 years) were taught a protocol for avoiding pregnancy with either online or in-person instruction. A hand-held fertility monitor was used to identify the fertile period by testing for urinary changes in estrogen and luteinizing hormone, and the results were tracked on a web site. During lactational amenorrhea, urine testing was done in 20-day intervals. When menses returned, the monitor was reset at the onset of each new menstrual cycle. Participants were instructed to avoid intercourse during the identified fertile period. Kaplan-Meier survival analysis was used to calculate unintentional pregnancy rates through the first 12 months postpartum. There were 8 unintended pregnancies per 100 women at 12 months postpartum. With correct use, there were 2 unintended pregnancies per 100 women at 12 months. The online postpartum protocol may effectively assist a select group of women in avoiding pregnancy during the transition to regular menstrual cycles.
Manhart MD et al., 2013·Osteopathic Family Physician
Each year, over three-fourths of the women of reproductive age in the United States seek family planning services from primary care clinicians. Women and their doctors should be informed of all effective family planning options and their respective effects on a woman's reproductive health. Family physicians are well-trained to support the behavior choices necessary for the successful adoption of any reversible family planning method. However, many are unfamiliar with fertility awareness-based methods (FABM) of family planning or have misconceptions about their effectiveness, complexity, or suitability for their patients. FABM teach women to observe the physical signs and symptoms that follow hormonal fluctuations throughout the menstrual cycle to identify a couple's fertile window, which can be used to avoid or achieve pregnancy. One in 5 women in the United States expressed interest in using FABM when informed about such options. When correctly used to avoid pregnancy, modern FABM have unintended pregnancy rates<5 (per 100 women years). Studies of modern FABM show that their typical unintended pregnancy rates are comparable to those of commonly used contraceptives. This article presents a review of the FABM literature to (1) familiarize the reader with the physiological basis and features of modern FABM, (2) present and utilize a framework to evaluate clinical evidence using the Strength of Recommendation Taxonomy (SORT), which supports the effectiveness of modern FABM for avoiding pregnancy, and (3) serve as a resource for health care professionals offering FABM options to their patients.
Polycystic Ovary Syndrome (PCOS) is a leading cause of infertility. We studied the rheological properties of cervical-vaginal secretions in five PCOS patients during variable treatment intervals with metformin. Five ovulatory normal women for a total of thirteen cycles served as control patients. All subjects collected daily cervical-vaginal fluid(CVF) samples with an aspirator, and CVF samples were characterized by a flow metric, die swell ratio (B), which measured CVF elasticity. Ovulatory cycles were indexed to the day of positive urine or serum LH (luteinizing hormone). CVF B levels from ovulatory normal women had a characteristic concave parabolic pattern of a minimum near the day of ovulation with higher values outside the periovulatory phase. In contrast, the five PCOS patients with or without metformin treatment had no periodicity of CVF B, and their CVF B levels were typically less compared to those in the early preovulatory and luteal phases of normal patients.
Natural family planning methods provide a unique option for committed couples. Advantages include the lack of medical adverse effects and the opportunity for participants to learn about reproduction. Modern methods of natural family planning involve observation of biologic markers to identify fertile days in a woman's reproductive cycle. The timing of intercourse can be planned to achieve or avoid pregnancy based on the identified fertile period. The current evidence for effectiveness of natural family planning methods is limited to lower-quality clinical trials without control groups. Nevertheless, perfect use of these methods is reported to be at least 95 percent effective in preventing pregnancy. The effectiveness of typical use is 76 percent, which demonstrates that motivation and commitment to the method are essential for success. Depending on the method, couples can learn about natural family planning methods in a single office visit, through online instruction, or from certified instructors.
The aim was to compare the efficacy and acceptability of two Internet-supported fertility-awareness-based methods of family planning. Six hundred and sixty-seven women and their male partners were randomized into either an electronic hormonal fertility monitor (EHFM) group or a cervical mucus monitoring (CMM) group. Both groups utilized a Web site with instructions, charts and support. Acceptability was assessed online at 1, 3 and 6 months. Pregnancy rates were determined by survival analysis. The EHFM participants (N=197) had a total pregnancy rate of 7 per 100 users over 12 months of use compared with 18.5 for the CMM group (N=164). The log rank survival test showed a significant difference (p<.01) in survival functions. Mean acceptability for both groups increased significantly over time (p<.0001). Continuation rates at 12 months were 40.6% for the monitor group and 36.6% for the mucus group. In comparison with the CMM, the EHFM method of family planning was more effective. All users had an increase in acceptability over time. Results are tempered by the high dropout rate.
Fertility AwarenessStandard Days MethodMale Partner EngagementCouple-Based Approaches
Family planning is often regarded as the woman's responsibility, but there is growing recognition of the need to involve men in family planning programs. Since 2001, the fertility-awareness-based Standard Days Method® (SDM) has been introduced in more than 30 countries, providing a natural, effective birth control option. SDM requires the cooperation of the male partner, and its introduction created an opportunity to test innovative strategies to engage couples in family planning. Such strategies included couple counselling, outreach activities that encouraged men to participate in family planning and integration of family planning into traditionally male programs. Due to the SDM's intrinsic characteristics as a couple method, SDM providers are sensitized to the importance of exploring other critical sexual and reproductive health topics, including intimate partner violence, HIV, sexuality and partner communication. This paper presents several case studies describing how men were engaged in SDM introduction activities in four countries.
The Standard Days Method (SDM) is a method of family planning that assumes ovulation to be close to the midpoint of the menstrual cycle; fertility falls between days 8 and 19; and is most effective for cycle lengths between twenty-six and thirty-two days. The purpose of this study was to evaluate the assumptions of the SDM with a new data set of 714 menstrual cycles produced by 131 women (mean age twenty-nine) who tracked their fertility with an electronic fertility monitor that measured urinary estrogen and luteinizing hormone (LH). The LH peak was used to estimate the day of ovulation (EDO) and the six-day fertile window. Results indicated the majority (80 percent) of menstrual cycles had EDOs within three days of the midpoint of the cycle (86 percent with cycle lengths between twenty-six and thirty-two days). Approximately 22.5 percent (172) of the cycles had fertile window days outside of days 8 to 19, 10.2 percent (78) before, and 12.1 percent (92) after. However, there is a low probability of pregnancy when women experience short cycles and the early days of the fertile window are outside of days 8 through 19. We concluded assumptions of the SDM outside of the fertile window with long cycles could be problematic. However, the SDM is valid for women who have most cycles within the twenty-six to thirty-two day range.
Beginning January 1, 2009, the Roman Catholic Diocese of Covington mandated that all engaged couples take a full course of NFP instruction as part of preparation for marriage within the Church. Using data from the Couple to Couple League and its Covington-based instructors, overall NFP instruction and characteristics of the couples attending classes before and after the mandate were examined. In the first two years, 66 percent and 77 percent of couples who married in the diocese, respectively, attended an NFP class. The mandate shifted the reasons for couples taking NFP instruction; prior to the mandate, 40 percent of engaged couples attended classes solely due to a pastor's requirement while 74 percent of engaged couples did so afterward (p < 0.001). Hormonal contraceptive use was common; 54 percent reported current use while another 23 percent reported former use. Current hormonal contraceptive use was significantly more common among those attending solely due to the mandate compared to those attending for multiple reasons (59 percent vs. 41 percent respectively, p = 0.004) and was significantly more common among engaged compared to married couples (53 percent vs. 8 percent respectively, p < 0.001). Cohabiting engaged couples were significantly more likely to have ever used hormonal contraceptives (91 percent vs. 71 percent, p < 0.0001), compared to engaged couples who were not cohabiting at the time of NFP instruction, and were significantly less likely to both be Catholic (55 percent vs. 70 percent, p = 0.002). Overall, implementation of mandatory NFP instruction as part of marriage preparation was successful; in post-class surveys, over 90 percent of couples acknowledged they had a better understanding of their fertility, and 83 percent would recommend the classes to a friend. Longer-term prospective follow-up is needed to evaluate the long-term impacts to couples exposed to such a requirement.
Fertility awareness constitutes fundamental knowledge for every woman and is an important tool for health professionals. The objective of this review is to show how fertility awareness can be useful in the assessment of a woman's health. The main techniques for detecting ovulation are explained, and then the events that characterize a normal menstrual cycle are discussed. The relevance of cervical mucus from the perspective of female fertility is highlighted. Finally, the usefulness of fertility awareness 1) to identify fertile and infertile periods, 2) to help to detect several pathologies, and 3) in regards to how it exerts an important role in the success of programs in education for affectivity and sexuality are discussed.
Hispanics are the largest minority group in the U.S. and they contribute to over 50 percent of Catholics under the age of 25. The purpose of this study was to determine the patterns of contraceptive use (current and ever), natural family planning (NFP), and abortion among U.S. Hispanic women between the ages of 15 and 44 years and to compare their patterns of use to non-Hispanic women of the same age range. A particular interest was to determine the influence of faith on the choice of family-planning methods among the sexually active U.S. Catholic Hispanic women. Data for this study came from the National Survey of Family Growth 2006-2008, which included 1,613 Hispanic and 5,743 non-Hispanic women between the ages of 15 and 44. Approximately 57 percent of the Hispanic women are Catholic. In general, U.S. Hispanic women had significantly less frequent use of the hormonal pill, male condom, withdrawal, and vasectomy (of male partner) but more frequent use of the IUD and Depo-Provera compared to non-Hispanic women. There was little use of NFP and no difference in the frequency of reported abortion. Catholic Hispanic women had significantly less frequent use of the male condom, the Pill, vasectomy, and abortion and more use of NFP compared to non-Catholic Hispanic women. Although there is some positive influence of faith among the sexually active Hispanic women of reproductive age, overall, the amount of ever use of sterilization (21 percent), condom use (80 percent), Pill use (66 percent), and Depo-Provera (30 percent) is remarkable. The more frequent use of Depo-Provera and the IUD might reflect the economic level of the participants and the use of federally funded family-planning services.
Body LiteracyClinician Training and PerspectivesTitle X Clinic ImplementationProvider Barriers and Facilitators
Natural family planning (NFP) methods are effective for contraception with proper and consistent use. However, only 1% of patients at federally funded Title X family planning clinics select NFP as a contraceptive method. The goal of this study was to understand from clinicians' perspectives the barriers and facilitators to providing NFP methods. Six telephone focus groups were conducted with 29 clinicians from Title X clinics across the United States and Puerto Rico. A hermeneutic method was used to analyze data for related themes. The overarching theme from the study was that participants had a strong desire to teach their patients how their bodies work and to empower them to learn to control fertility. patient misinformation and misunderstanding about fertility; provider ideas about ideal types of candidates for NFP; inconsistent patient teaching strategies; and lack of time to teach NFP methods. There is a need for increased NFP training for providers and efficient NFP patient teaching strategies to meet the needs of patients with limited knowledge about fertility.
Fertility AwarenessAcceptability and UsePatient Knowledge and AwarenessFamily Planning Method Adoption
Open Access
This is an observational quantitative and analytical study aimed at verifying the knowledge, acceptability and use of natural family planning (NFP) by patients in a university hospital from July to November, 2008. The data were collected using a structured questionnaire and analyzed with the softwares Excel and Statistica 8.0. Of the 113s women interviewed, 70 (62%) accepted the method and 1 (0.9%) used it routinely. Acceptance was higher among those who wished to become pregnant in the future compared to those who did not wish it. Acceptability was statistically significant (p = 0.0147) among the 28 (80%) non-contraceptive users compared to 42 (53.8%) who used some contraceptive method. Factors such as age, education, number of living children and religion were not statiscally associated with the acceptability of NFP. The Billings ovulation method has an adequate acceptability, but has a low actual use because of the lack of information by health professionals of its real effectiveness and applicability.
Fertility AwarenessUrinary Hormone MetabolitesHome-Based Hormone TestingEstrogen and Progesterone Profiles
The UNDP/WHO/World Bank/Special Programme of Research, Development and Research Training in Human Reproduction (Geneva) set up a study to determine whether it is feasible for women to monitor their ovarian activity reliably by home testing. Daily self-monitoring of urinary hormone metabolites for menstrual cycle assessment was evaluated by comparison of results obtained with the Home Ovarian Monitor by untrained users both at home and in study centres. Women collected daily data for urinary estrone glucuronide (E1G) and pregnanediol glucuronide (PdG) for two cycles, then the procedure was repeated in the women's local centre (in Chile, Australia or New Zealand) giving a total of 113 duplicate cycles. The tests were performed without the benefit of replicates or quality controls. The home and centre cycles were normalized and compared to identify assay errors, and the resulting home and centre menstrual cycle profiles were averaged. Reliable mean cycle profiles were obtained with the home and centre excretion rates agreeing to within 36 ± 21 nmol/24 h for E1G and 0.77 ± 0.28 µmol/24 h for baseline PdG values (1-5 µmol/24 h). The cycles had a mean length of 28.1 ± 3.1 days (n = 112; 5th and 95th 24 and 35 days, respectively), a mean follicular phase of 14.8 ± 3.1 days (n = 107; 5th and 95th 11 and 21 days) and a mean luteal phase length of 13.3 ± 1.5 days (n = 106; 5th and 95th 11 and 17 days), calculated from the day of the LH peak. The study confirmed that the Ovarian Monitor pre-coated assay tubes worked well even in the hands of lay users, without standard curves, quality controls or replicates. Point-of-care monitoring to give reliable fertility data is feasible.
Fertility AwarenessHormonal IndicatorsFollicular DevelopmentBiomarker-Based Methods
Open Access
El objetivo de este artículo es revisar los principales conceptos en la literatura acerca de la ventana de la fertilidad en pacientes con ciclos menstruales normales. El énfasis principal del artículo se ha dirigido al análisis de la teoría de Brown de la ovulación, revisar conceptos básicos de la ovulación, secreción y metabolismo de la hormona folículo estimulante, y al estudio clínico, ecográfico y bioquímicos del desarrollo folicular de la ventana de la fertilidad. Este artículo también repasa los biomarcadores clínicos y los diferentes metabolitos endocrinos que delimitan en la fase fértil del ciclo. Se revisan diferentes estudios en los cuales las valoraciones en suero y orina de los esteroides sexuales, han corroborado tener una correlación directa para enmarcar el período fértil. Actualmente tienen relevancia estos conocimientos en diferentes grupos de interés, sobre todo en mujeres con un alto nivel de motivación interesadas en el reconocimiento de su fertilidad, las cuales pueden beneficiarse mediante la aplicación de conocimientos técnicos actuales que detectan la ventana fértil. También estos conocimientos suelen cobrar importancia en aquellas personas que pertenecen a programas de regulación de la fertilidad (PRF), con intención de distanciar un embarazo, o de reconocer el periodo fértil del ciclo para conseguir un embarazo espontáneamente, o mediante programas de NaProTecnología. Otros grupos de interés, son aquellos en los cuales no se tiene experiencia en cursos de PRF, pero desean mejorar sus conocimientos en el reconocimiento de la fertilidad por medio de una breve entrevista, o por medio de cursos de orientación familiar.
In current medical practice, many women are prescribed hormonal contraceptives as a method of family planning. Over the years, medical professionals have prescribed hormonal contraceptives to manage numerous health conditions in addition to family planning purposes. A particular question arises in regard to women taking hormonal contraceptives for therapeutic reasons if the drug has a contraceptive effect and abortifacient properties. An important consideration is a definite lack of knowledge among medical professionals and patients about alternatives to hormonal contraceptives. To most lay people and medical professionals, fertility awareness-based methods equate to the outdated calendar rhythm method and therefore tend to be regarded as mostly a matter of chance so that they would have no benefit in helping manage gynecological conditions. In this paper, one will be able to see that modern fertility awareness-based methods are effective as a method of family planning and that there are medical applications that offer an excellent alternative in the treatment of various gynecological conditions, including infertility.
Fehring RJ et al., 2011·J Obstet Gynecol Neonatal Nurs
To evaluate the efficacy, knowledge of fertility, and acceptability of a web-based natural family planning (NFP) education and service program.
A 6-month repeated measure longitudinal evaluation pilot study.
A university based online website. The website was piloted with 468 volunteer women seeking NFP services. Of these participants, 222 used the automatic online fertility charting system to avoid pregnancy. The 222 charting participants had a mean age of 29.9 years (SD=5.6), 2.2 children (SD=1.9), 37% were postpartum, and 47% had regular menstrual cycle lengths. Nurse-managed web-based NFP education and service program. Pregnancies were confirmed by an online self-assessed pregnancy evaluation form. A 10-item fertility quiz and 10-item acceptability survey was administered online. Among the 222 users avoiding pregnancy, at 6 months of use, there were two correct-use unintended pregnancies that provided a pregnancy rate of 2% and seven total unintended pregnancies providing a typical use pregnancy rate of 7%. Mean knowledge of fertility increased significantly from time of registration (8.96, SD=1.10) to 1 month of use (9.46, SD=.10), t=4.60, p<.001). Acceptability increased nonsignificantly from 1 month of use (45.6; SD=8.98) to 6 months of use (48.4; SD=8.77). The nurse-managed online NFP system seems to provide adequate knowledge of fertility and help participants meet pregnancy intentions. Acceptability of such a system of NFP is still in question.
Fertility AwarenessProgram IntegrationEffectivenessFertility Awareness Methods
Open Access
To determine what contribution the Standard Days Method® (SDM) makes to the contraceptive mix offered by regular health services in areas of Peru where contraceptive prevalence rates (CPR) are already high. SDM was added to the family planning methods offered by the Ministry of Health in two provinces in Peru in September 2002. Retrospective interviews were conducted in March-June 2004 with 1 200 women who had chosen SDM as their contraceptive method and had used it for 2-20 months. Data were also obtained from the databases of the participating health services. The evaluation covered SDM demand, whether or not clients were switching to SDM from other modern methods, and SDM continuation and effectiveness. Demand for SDM stabilized at 6% of all new family planning users. Most users had not been using any reliable contraception at the time they started using SDM. About 89% of those who began using SDM at least 6 months before the interview were still using it at 6 months. The 12-month typical use pregnancy rate was estimated to be around 10.0 per 100 women years. Adding SDM to a program's existing contraceptive method mix can increase coverage even in an already high-CPR setting. Most women who choose SDM do not switch from any other modern family planning method. Continuation compares well with other modern user-directed methods. SDM effectiveness, when offered in regular service delivery circumstances, compares well to efficacy trial findings.
Fertility AwarenessMethod-Specific EffectivenessComparison of NFP ApproachesClassification of Natural Methods
Freundl G, 2010·Eur J Contracept Reprod Health Care
This letter to the editor discusses a review article commenting on the efficacy of contraceptive methods. It takes issue with section focused on natural family planning methods (Billings ovulation method calendar methods symptothermal method etc) and finds fault with the authors not differentiating between the various natural methods. It states that if the authors consider it appropriate to differentiate between the various hormonal contraceptives then differentiation between the natural methods is mandatory.
Fertility AwarenessPhysician Knowledge and AttitudesContraceptive Counseling PracticesCross-Sectional Physician Survey
To assess physicians' knowledge, attitudes, and practice with respect to four evidence-based natural family planning (NFP) Standard Days, cervical mucus, basal body temperature, and the lactational amenorrhea method. We undertook a cross-sectional survey of a random sample of family physicians and all gynaecologists in British Columbia (n = 460) who have women of reproductive age in their practice, as well as all affiliated residents (n = 239). Main outcome measures were (1) physicians' attitudes towards NFP and their perceptions of its effectiveness; (2) the relationship between physicians' demographic factors, their personal experience or beliefs, and their attitudes and knowledge; and (3) how these factors affect the counselling physicians offer their patients. The survey response rate was 44%. Only 3% to 6% of physicians had correct knowledge of the effectiveness in perfect use of the NFP methods cited in this study. Fifty percent of physicians who responded mention NFP to their patients as an option for contraception, and 77% of physicians mention NFP as an option to couples trying to conceive. Family physicians and residents were much more likely than gynaecologists or gynaecology residents to mention NFP during counselling. Older physicians were more likely to mention NFP than younger physicians and also had more personal experience with NFP. Most physicians in our study underestimated the effectiveness of NFP methods, and only a small proportion of physicians provide information about NFP during contraceptive counselling. Physicians need better understanding of modern methods of NFP to provide evidence-based contraceptive counselling to selected highly motivated patients who prefer NFP as a contraceptive choice.
Menstrual CycleSubclinical AnovulationOvulatory Disturbance EffectsBasal Body Temperature
Cognitive dietary restraint (CDR) of limiting food intake to achieve/maintain a perceived ideal body weight. The objective of this 2‐yr prospective study was to determine if women with higher CDR have more subclinical ovulation disturbances (SOD; anovulation or luteal phase <10 d), elevated cortisol excretion and less positive changes in areal bone mineral density over two years (ΔaBMD). Participants were 123 healthy, non‐obese, regularly menstruating women aged 19–35. Annually participants completed questionnaires (Three Factor Eating Questionnaire, physical activity, general stress, dietary intake), anthropometrics and 24‐hr urine collections for measurement of 24‐hr urinary free cortisol (UFC). At baseline and final follow‐up, dual energy x‐ray absorptiometry scans measured ΔaBMD at the lumbar spine (L1‐4), hip and total body. Quantitative waking temperature was used to determine SOD frequency. SOD correlated positively with CDR and inversely with hip ΔaBMD but not with UFC. CDR and UFC were not associated with each other or ΔaBMD. Women with higher CDR had more SOD. Women with more SOD had less positive ΔaBMD and higher CDR. Physical activity, general stress, body mass and energy intake did not explain differences by CDR or SOD. In conclusion, CDR was the only study variable associated with SOD which was associated with less positive ΔaBMD. Canadian Institutes of Health Research 79563.
: Canadian Institute of Health Research
Fertility AwarenessCervical Mucus ModelingLatent Class ModelsMultivariate Marker Analysis
Dynamic latent class models provide a flexible framework for studying biologic processes that evolve over time. Motivated by studies of markers of the fertile days of the menstrual cycle, we propose a discrete-time dynamic latent class framework, allowing change points to depend on time, fixed predictors, and random effects. Observed data consist of multivariate categorical indicators, which change dynamically in a flexible manner according to latent class status. Given the flexibility of the framework, which incorporates semi-parametric components using mixtures of betas, identifiability constraints are needed to define the latent classes. Such constraints are most appropriately based on the known biology of the process. The Bayesian method is developed particularly for analyzing mucus symptom data from a study of women using natural family planning.
Fertility AwarenessBasal Body TemperatureTemperature Analysis MethodsProgesterone Confirmation Methods
Jennifer L Bedford et al., 2009·Eur J Obstet Gynecol Reprod Biol
To assess computerised least-squares analysis of quantitative basal temperature (LS-BT) against urinary pregnanediol glucuronide (PdG) as an indirect measure of ovulation, and to evaluate the stability of LS-QBT to wake-time variation. Cross-sectional study of 40 healthy, normal-weight, regularly menstruating women aged 19-34. Participants recorded basal temperature and collected first void urine daily for one complete menstrual cycle. Evidence of luteal activity (ELA), an indirect ovulation indicator, was assessed using Kassam's PdG algorithm, which identifies a sustained 3-day PdG rise, and the LS-QBT algorithm, by determining whether the temperature curve is significantly biphasic. Cycles were classified as ELA(+) or ELA(-). We explored the need to pre-screen for wake-time variations by (A) all recorded temperatures, (B) wake-time adjusted temperatures, (C) temperatures within 2h of average wake-time, and (D) expert reviewed temperatures. Relative to PdG, classification of cycles as ELA(+) was 35 of 36 for LS-QBT methods A and B, 33 of 34 (method C) and 30 of 31 (method D). Classification of cycles as ELA(-) was 1 of 4 (methods A and B) and 0 of 3 (methods C and D). Positive predictive value was 92% for methods A-C and 91% for method D. Negative predictive value was 50% for methods A and B and 0% for methods C and D. Overall accuracy was 90% for methods A and B, 89% for method C and 88% for method D. The day of a significant temperature increase by LS-QBT and the first day of a sustained PdG rise were correlated (r=0.803, 0.741, 0.651, 0.747 for methods A-D, respectively, all p<0.001). LS-QBT showed excellent detection of ELA(+) cycles (sensitivity, positive predictive value) but poor detection of ELA(-) cycles (specificity, negative predictive value) relative to urinary PdG. Correlations between the methods and overall accuracy were good and similar for all analyses. Findings suggest that LS-QBT is robust to wake-time variability and that expert interpretation is unnecessary. This method shows promise for use as an epidemiological tool to document cyclic progesterone increase. Further validation relative to daily transvaginal ultrasound is required.
To determine if an electronic hormonal fertility monitor aided method (EHFM) of family planning is more effective than a cervical mucus only method (CMM) in helping couples to avoid pregnancy. Six hundred twenty-eight women were taught how to avoid pregnancy with either the EHFM (n=313) or the CMM (n = 315). Both methods involved standardized group teaching and individual follow-up. All pregnancies were reviewed and classified by health professionals. Correct use and total unintended pregnancy rates over 12 months of use were determined by survival analysis. Comparisons of unintended pregnancies between the 2 methods were made by use of the Fisher exact test. There were a total of 28 unintended pregnancies with the EFHM and 41 with the CMM. The 12-month correct use pregnancy rate of the monitor-aided method was 2.0%, and the total pregnancy rate was 12.0%. In comparison, the 12-month correct use pregnancy rate of the CMM was 3.0%, and the total pregnancy rate was 23.0%. There was a significant difference in total pregnancies between the 2 groups (p<0.05). EFHM is more effective than CMM. Further research is needed to verify the results.
Fertility AwarenessReview ArticlesPhysician Knowledge and TrainingFamily Planning Applications
Modern fertility awareness-based methods (FABMs) of family planning have been offered as alternative methods of family planning. Billings Ovulation Method, the Creighton Model, and the Symptothermal Method are the more widely used FABMs and can be more narrowly defined as natural family planning. The first 2 methods are based on the examination of cervical secretions to assess fertility. The Symptothermal Method combines characteristics of cervical secretions, basal body temperature, and historical cycle data to determine fertility. FABMs also include the more recently developed Standard Days Method and TwoDays Method. All are distinct from the more traditional rhythm and basal body temperature methods alone. Although these older methods are not highly effective, modern FABMs have typical-use unintended pregnancy rates of 1% to 3% in both industrialized and nonindustrialized nations. Studies suggest that in the United States physician knowledge of FABMs is frequently incomplete. We review the available evidence about the effectiveness for preventing unintended pregnancy, prognostic social demographics of users of the methods, and social outcomes related to FABMs, all of which suggest that family physicians can offer modern FABMs as effective means of family planning. We also provide suggestions about useful educational and instructional resources for family physicians and their patients.
Fertility AwarenessNFP Efficacy and EffectivenessCatholic Healthcare IntegrationBarriers and Adoption
Relatively few Catholic couples in the United States use modern methods of natural family planning (NFP). So too, few Catholic physicians and health professionals prescribe the use of NFP methods for their patients. Reasons for low use of NFP methods include their perceived low efficacy; the complexity of learning, using, and teaching these methods; and the prolonged (and often unnecessary) required abstinence. Newer and simplified methods of NFP have been developed by physicians and scientists that are less complex and use modern technologies of detecting fertility and communicating instructions. Catholic physicians and scientists need to continue to answer the call by the Holy Fathers (from Pius XII to Benedict XVI) to develop secure and scientifically sound methods of NFP.
Two types of cervical mucus are recognized, oestrogenic and gestagenic. These are constituted by different subtypes, and their characteristics change depending on variations in the hormonal levels and on the existence of several pathologies. Our aim was to identify the ultrastructure and crystallization characteristics of the cervical mucus in women suffering from polycystic ovary syndrome, and to compare these characteristics with those of normal control women. Cervical mucus samples were taken from 10 women, 4 control group women (with normal ovulatory menstrual cycles) and 6 suffering from polycystic ovary syndrome (2 with ovulatory and 4 with anovulatory cycles). This mucus was characterized according to its ultrastructure and crystallization. The type of mucus obtained was related to the levels of oestradiol and progesterone present when the samples were taken. As regards mucus ultrastructure, differences were found between the control women and those with polycystic ovary syndrome and anovulatory menstrual cycles. Such variations were evident in the type of mesh and the average diameter of the mucus pores. Mucus crystallization in control women showed the fern-like (L, P2), rectilinear (S) or a hexagonal structure (P6). On the other hand, in women with polycystic ovary syndrome, indefinite mucus crystallizations were found, as well as crystallization patches resembling oestrogenic and gestagenic-like mucus. This study shows that the ultrastructure and crystallization characteristics of the cervical mucus in polycystic ovary syndrome women are different from those of control women. The latter would be dependent on their levels of oestradiol and progesterone.
Ethics/PhilosophyPhysician ResponsibilitiesCatholic Physician NFP RoleNFP Advocacy and Promotion
To assess the amount of variability in ovarian follicular growth rate and maximum follicular diameter related to different centers, women and cycles of the same women in a multicenter observational study of follicular growth. Secondary analysis of a prospective cohort study from eight centers in Europe. There were 533 ultrasound examinations in 282 cycles of 107 women with normal fertility. A random effects model with center, woman and cycle as hierarchical units of variation was used to analyze mean follicular diameter on days preceding ovulation. Follicular growth did not differ by center. There was homogenous growth across women and cycles, and the maximum follicular diameter before ovulation varied substantially across cycles but not across women. Many (about 40%) women had small maximum follicular diameter on the day before ovulation (<19 mm). Pre-ovulatory cycle length was not related to maximum follicular diameter. In normal fecundity, there is a substantial variation in maximum follicular diameter from cycle to cycle based on variation in the duration of follicular development, but the variation could not be explained by different characteristics of different women. Explanation of variation in follicular growth has to be found on the cycle level.
Fehring RJ et al., 2008·MCN Am J Matern Child Nurs
To determine the effectiveness of the Marquette Method (MM) of natural family planning (NFP) as a method of avoiding pregnancy. This was a 12-month retrospective evaluation of the MM system of NFP. Two hundred and four women (mean age, 28.6 years) and their male partners (mean age, 30.3 years) who sought to learn a method for avoiding pregnancy with the MM from four clinical sites were taught to track their fertility by self-observation of cervical mucus, by use of an electronic monitor that measures urinary levels of estrone-3-glucuronide and luteinizing hormone, and by use of basal body temperature. All unintended pregnancies were evaluated by professional nurses as to whether they were intended or not. Pregnancy rates over 12 months of use were determined by survival analysis. There were a total of 12 unintended pregnancies, only 1 with correct use. The 12-month "correct use" pregnancy rate was 0.6 (i.e., 99.4% effective) and the "typical use" (total pregnancy rate) was 10.6 (i.e., 89.4% effective) per 100 users.
When used correctly, the MM system of NFP is an effective means of avoiding pregnancy. The efficacy of the MM system includes proper preparation of the professional nurse NFP teachers.
NaProTECHNOLOGYClinical OutcomesLive Birth RatesGeneral Practice Setting
We evaluated outcomes in couples treated for infertility with natural procreative technology (NaProTechnology [corrected] NPT), a systematic medical approach for optimizing physiologic conditions for conception in vivo, from an Irish general practice. All couples receiving treatment from 2 NPT-trained family physicians between February 1998 and January 2002 were studied. The main outcome was live birth, and secondary outcomes included conceptions and multiple births. Crude proportions and adjusted life-table proportions were calculated per 100 couples. A total of 1239 couples had an initial consult for NPT, of which 1072 had been trying for at least a year to conceive and initiated treatment. The average female age was 35.8 years, the mean duration of attempting to conceive was 5.6 years, 24% had a prior birth, and 33% had previously attempted treatment with assisted reproductive technology (ART). All couples were taught to identify the fertile days of the menstrual cycle with the Creighton Model FertilityCare System, and most received additional medical treatment, including clomiphene (75%). In life-table analysis, the cumulative proportion of first live births for those completing up to 24 months of NPT treatment was 52.8 per 100 couples. The crude proportion was 25.5. Younger couples and couples without previous ART attempts had higher rates of live birth. Among live births, there were 4.6% twin births. NPT provided by trained general practitioners had live birth rates comparable to cohort studies of more invasive treatments, including ART. Further studies are warranted to compare NPT directly to other treatments.
AndrologyAcrosome ReactionEstradiol Effects on SpermHormonal Interactions
The acrosome is a secretory vesicle located in the sperm head. The acrosome reaction consists in the fusion of the sperm plasma membrane with the external acrosomal membrane. It has been observed that this reaction does not take place in spermatozoa incubated in cervical mucus, hydrogel that contains high concentrations of oestradiol in the peri-ovulatory period. The objective of the present study was to analyse the influence of oestradiol on the acrosome reaction in human spermatozoa to evaluate the possible inhibitory effect of this hormone. Spermatozoa were incubated in progesterone (10.1 nmol l(-1)); oestradiol plus progesterone (oestradiol at 840 pmol l(-1) and progesterone at 10.1 nmol l(-1)), oestradiol (840 pmol l(-1)) and control (without steroidal hormones) for 30 min, 60 min, 240 min and 24 h. The acrosome reaction was evaluated by stain with Hoechst 33258 and fluorescein isothiocyanate-conjugated Pisum sativum agglutinin lectin. Progesterone-incubated spermatozoa showed the highest percentage of acrosome reaction (P < 0.05). Spermatozoa incubated with oestradiol and oestradiol plus progesterone showed the lowest percentage of acrosome reaction. The present study demonstrates the inhibitory role of oestradiol on the acrosome reaction, stimulated by progesterone in human spermatozoa under physiological conditions.
Fertility AwarenessProgram ImplementationTypical Use EffectivenessCommunity-Based Providers
Many national and institutional family planning policies explicitly include fertility awareness-based methods among the method options that should be made available, but these methods are often not offered for a variety of reasons. After testing the efficacy of the Standard Days Method (SDM), which is a fertility awareness-based method that identifies Days 8-19 of the menstrual cycle as fertile for women with cycles lasting between 26 and 32 days, pilot studies were conducted to introduce it into programs. Through 14 pilot studies around the world, ministries of health, family planning associations and community development organizations introduced the SDM. Follow-up interviews with users and other data collection methodologies were used to track user characteristics and experiences. Supervision data and simulated clients assessed the effects on service delivery. The SDM appeals to a broad range of women throughout the world. Clients report using abstinence or condoms to manage the fertile days. Both men and women report high levels of satisfaction with the method. The cross-study first-year failure rate of 14.1 pregnancies per 100 woman-years of use is similar to typical-use rates found in the SDM efficacy trial. The results of the pilot studies offer guidance for scaling up service delivery of the SDM. Condom counseling can help many users manage the fertile window effectively. Because out-of-range cycles can lead to method failure, users must understand the importance of tracking cycle length and be willing to switch to another method when the SDM is contraindicated. Community providers can offer the method; within clinical settings, SDM counseling typically takes no more time than allowed in most program norms. Training providers to address alcohol use and gender-based violence improves SDM method use and contributes to better quality of care.
Fertility AwarenessFertile Window EstimationVariability and DurationE3G and LH Detection
The purpose of this study was to determine the variability in length of the fertile phase of the menstrual cycle with 140 participants who produced 1,060 cycles with an electronic hormonal fertility monitor. The length of the fertile phase, as defined by the first day with a threshold level of urinary E3G and ending with a second day above a threshold of LH, varied from <1 to >7 days, with the most frequent length being 3 days.
The period in each menstrual cycle during which sexual intercourse can result in conception is called the "fertile window". Although the fertile window closes on the day of ovulation, little is known about the moment it opens. We defined the first day of normal sperm-mucus interaction as the opening of the fertile window. We hypothesized that length of the fertile window varies between couples and that the number of days the fertile window is "open" is related to the time to spontaneous conception. METHODS Serial post-coital tests and sperm-mucus penetration tests were performed to detect the first normal sperm-mucus interaction day. Ovulation was confirmed by serial ultrasound. Using Cox' regression analysis, we determined whether the fertile window length was associated with time to ongoing pregnancy. This association was expressed in fecundability ratios (FR). RESULTS The fertile window length was determined in 410 subfertile couples. The fertile window length varied among couples from <1 to >5 days. The FR increased with increasing fertile window length and varied between 0.11 (95% CI: 0.03-0.45) for a fertile window of 1 day, to 2.4 (95% CI: 1.1-5.2) for a fertile window of 5 days or more. CONCLUSIONS The longer the fertile window in subfertile couples, the higher is the probability of spontaneously conceiving an ongoing pregnancy.
Fertility AwarenessElectronic Hormonal MonitoringCorrect and Typical Use RatesCervical Mucus Monitoring
Fehring RJ et al., 2007·J Obstet Gynecol Neonatal Nurs
To determine the effectiveness of an electronic hormonal fertility monitor plus cervical mucus monitoring to avoid pregnancy.
A 12-month prospective clinical efficacy trial. One hundred ninety five (195) women (mean age 29.8 years) seeking to avoid pregnancy with a natural method at 5 clinical sites in 4 cities. Each participant was taught to track fertility by self-observation of cervical mucus and an electronic monitor that measures urinary levels of estrone-3-glucuronide and luteinizing hormone. Correctand typical-use unintended pregnancy rates. There were a total of 26 unintended pregnancies, 3 with correct use. With 1,795 months of use, the correct-use pregnancy rate was 2.1% per 12 months of use (i.e., 97.9% effective in avoiding pregnancy when rules of the method were always followed) and the imperfect-use pregnancy rate was 14.2% per 12 months of use (i.e., 85.8% effective in avoiding pregnancy when rules of the method were not always followed and all unintended pregnancies and months of use were included in the calculations). Correct use of an electronic hormonal fertility monitor with cervical mucus observations can be as effective as other fertility awareness-based methods of natural family planning. Comparative studies are needed to confirm this conclusion.
Fertility AwarenessSymptothermal MethodPerfect and Imperfect Use RatesProspective Cohort Studies
The efficacy of fertility awareness based (FAB) methods of family planning is critically reviewed. The objective was to investigate the efficacy and the acceptability of the symptothermal method (STM), an FAB method that uses two indicators of fertility, temperature and cervical secretions observation. This paper will recommend a more suitable approach to measure the efficacy. Since 1985, an ongoing prospective observational longitudinal cohort study has been conducted in Germany. Women are asked to submit their menstrual cycle charts that record daily basal body temperature, cervical secretion observations and sexual behaviour. A cohort of 900 women contributed 17,638 cycles that met the inclusion criteria for the effectiveness study. The overall rates of unintended pregnancies and dropout rates have been estimated with survival curves according to the Kaplan-Meier method. In order to estimate the true method effectiveness, the pregnancy rates have been calculated in relation to sexual behaviour using the 'perfect/imperfect-use' model of Trussell and Grummer-Strawn. After 13 cycles, 1.8 per 100 women of the cohort experienced an unintended pregnancy; 9.2 per 100 women dropped out because of dissatisfaction with the method; the pregnancy rate was 0.6 per 100 women and per 13 cycles when there was no unprotected intercourse in the fertile time. The STM is a highly effective family planning method, provided the appropriate guidelines are consistently adhered to.
Fertility AwarenessFecundability EstimationTime to Pregnancy StudiesIntercourse Pattern Effects
Time to pregnancy, typically defined as the number of menstrual cycles required to achieve a clinical pregnancy, is widely used as a measure of couple fecundity in epidemiologic studies. Time to pregnancy studies seldom utilize detailed data on the timing and frequency of sexual intercourse and the timing of ovulation. However, the simulated models in this paper illustrate that intercourse behavior can have a large impact on time to pregnancy and, likewise, on fecundability ratios, especially under conditions of low intercourse frequency or low fecundity. Because intercourse patterns in the menstrual cycles may vary substantially among groups, it is important to consider the effects of sexual behavior. Where relevant and feasible, an assessment should be made of the timing and frequency of intercourse relative to ovulation. Day-specific probabilities of pregnancy can be used to account for the effects of intercourse patterns. Depending on the research hypothesis, intercourse patterns may be considered as a potential confounder, mediator, or outcome.
Fertility AwarenessFecundity MeasurementDay-Specific Conception ProbabilitiesFertility Cycle Data Analysis
Mikolajczyk RT et al., 2006·Paediatr Perinat Epidemiol
Approaches to measuring fecundity include the assessment of time to pregnancy and day-specific probabilities of conception (daily fecundities) indexed to a day of ovulation. In this paper, we develop an additional approach of calculating expected pregnancies based on daily fecundities indexed to the last day of the menstrual cycle. Expected pregnancies can thus be calculated while controlling for frequency and timing of coitus. Comparing observed pregnancies with expected pregnancies allows for a standardised comparison of fecundity between studies or groups within studies, and can be used to assess the effects of categorical covariates on the woman or couple level, and also on the cycle level. This can be accomplished in a minimal data set that does not necessarily require hormonal measurement or the explicit identification of ovulation. We demonstrate this approach by examining the effects of age and parity on fecundity in a data set from women monitoring their fertility cycles with the Creighton Model FertilityCare System.
Fertility AwarenessDay-Specific Conception ProbabilitiesBiomarkers and Proxy MeasuresPericonceptional Window Assessment
Conception, as defined by the fertilisation of an ovum by a sperm, marks the beginning of human development. Currently, a biomarker of conception is not available; as conception occurs shortly after ovulation, the latter can be used as a proxy for the time of conception. In the absence of serial ultrasound examinations, ovulation cannot be readily visualised leaving researchers to rely on proxy measures of ovulation that are subject to error. The most commonly charting basal body temperature, monitoring cervical mucus, and measuring urinary metabolites of oestradiol and luteinising hormone. Establishing the timing of the ovulation and the fertile window has practical utility in that it will assist couples in appropriately timing intercourse to achieve or avoid pregnancy. Identifying the likely day of conception is clinically relevant because it has the potential to facilitate more accurate pregnancy dating, thereby reducing the iatrogenic risks associated with uncertain gestation. Using data from prospective studies of couples attempting to conceive, several researchers have developed models for estimating the day-specific probabilities of conception. Elucidating these will allow researchers to more accurately estimate the day of conception, thus spawning research initiatives that will expand our current limited knowledge about the effect of exposures at critical periconceptional windows. While basal body temperature charting and cervical mucus monitoring have been used with success in field-based studies for many years, recent advances in science and technology have made it possible for women to get instant feedback regarding their daily fertility status by monitoring urinary metabolites of reproductive hormones in the privacy of their own homes. Not only are innovations such as luteinising hormone test kits and digital fertility monitors likely to increase study compliance and participation rates, they provide valuable prospective data that can be used in epidemiological research. Although we have made great strides in estimating the timing and length of the fertile window, more work is needed to elucidate the day-specific probabilities of conception using proxy measures of ovulation that are inherently subject to error. Modelling approaches that incorporate the use of multiple markers of ovulation offer great promise to fill these important data gaps.
Fertility AwarenessStandard Days and TwoDay MethodCoital Frequency and TimingBehavioral Outcomes FAB Methods
Fertility awareness-based methods of family planning help women to identify the days of the cycle they should avoid unprotected intercourse to prevent pregnancy. Therefore using fertility awareness-based methods influences the timing of sexual activity, which may affect the nature of the sexual relationship. Data are used from the clinical trials of two fertility awareness-based methods--the Standard Days Method and the TwoDay Method--to determine the frequency and timing of intercourse during the cycle, and the determinants of coital frequency. The mean coital frequency of study participants was similar to that reported by users of other methods. Results suggest that coital frequency increases with consecutive cycles of method use. At the same time the frequency of intercourse during the identified fertile days and during menses decreases. This evidence implies a behavioural change as couples get more experience using their method and communicating about the fertile days. Coital frequency was also influenced by the method used and by the study sites. Potential differences between the methods and sites that may contribute to this effect are discussed.
Fertility AwarenessKnowledge Attitude PracticeRhythm MethodDeveloping Countries
Sub-Saharan Africa has one of the highest fertility rates in the world, which is further promoted by the low utilisation of modern contraceptive methods. Yet, many communities claim to have traditional methods of family planning that pre-date the introduction of modern contraceptives, implying that contraception is a culturally acceptable norm. It was therefore postulated that the study population would have a high level of awareness and practice of natural methods of family planning. We aimed to obtain an insight into the extent and correctness of knowledge about natural family planning methods, and its practice as a guide to the general acceptance of contraception as a concept. Pre-tested structured questionnaires were administered to women of childbearing age in households properly numbered for primary healthcare activities. The level of awareness of natural family planning methods was significantly less than awareness for modern methods of contraception. The awareness rate for rhythm method, lactational amenorrhoea method and coitus interruptus was 50.7%, 42.1% and 36.1%, respectively. For all three national family planning methods, there is a steady decline between awareness, correct description of method and utilisation, a difference that was statistically significant in all cases. The sociodemographic factors of the responders had varying influence on utilisation of all three natural family planning methods studied. Rural dwellers practised the lactational amenorrhoea method significantly more often than urban dwellers. Significantly more Muslims than Christians with four children or more practised coitus interruptus or the rhythm method, while the use of lactational amenorrhoea method was significantly increased with the number of living children in both religious groups. There is a relatively low level of awareness of natural family planning methods in the study population, poor utilisation and wrong use of methods. Therefore, improving the correct level of information on natural family planning methods is likely to improve the use of both natural family planning and modern contraceptive methods.
We performed a cross-sectional survey of 357 reproductive-aged women, mostly Hispanic (81.8%), presenting for ambulatory and hospital reproductive care in Phoenix, AZ, about their interest in natural family planning (NFP). Participants completed questionnaires, and responses were analyzed to determine predictors of interest in NFP. Sixty-one percent stated that they were likely or very likely to use NFP to avoid pregnancy, and 50% would use NFP to achieve pregnancy. Of factors studied, Hispanic ethnicity, lower level of acculturation, less education and recent use of condoms or withdrawal were independently associated with interest in using NFP to avoid pregnancy. Younger age and desire for future pregnancy were independently predictive of potential NFP use to achieve pregnancy. This study suggests that Hispanic women find NFP to be an appealing family planning alternative.
Fertility AwarenessStandard Days MethodTwoDay MethodCorrect Use Predictors
Fertility awareness-based methods of family planning help women identify the days of the menstrual cycle when they are most likely to become pregnant. To prevent pregnancy, women avoid unprotected intercourse on these days. Efficacy of these methods may be improved if the users most likely to engage in unprotected intercourse on fertile days can be identified and counseled. Quantitative and qualitative data from efficacy studies of the Standard Days Method and the TwoDay Method of family planning, in which 928 women each contributed up to 13 cycles of method use, were examined. Multinomial logit analysis was used to compare characteristics of women who occasionally had unprotected intercourse on fertile days with those who consistently used their method correctly. The reasons participants gave for having unprotected intercourse on fertile days were also examined. Only 23% of women had unprotected intercourse on their fertile days in one or more of the cycles they contributed to the study. The method and study site appear to have the most significant effect on correct use. Earning an income was associated with increased odds of unprotected intercourse on fertile days; higher quality of housing was associated with decreased odds. The results confirm the importance of partner cooperation for correct method use. There was no clear profile of clients for whom these family planning methods would be inappropriate. However, programs offering these methods may help couples overcome potential difficulties in correct method use by including male partners and encouraging their participation in counseling sessions.
In the discussion of biologic differences between male and female fertility (April 6 issue),1 Federman states that women are fertile for only 12 hours each month. Although the egg is viable for 12 hours or less, the window of fertility in women is approximately five to six days in each menstrual cycle,24 depending on the presence of estrogenic cervical mucus that maximizes the storage, survival, and transport of sperm until ovulation.4,5 Dr. Stanford rightly calls attention to the elegant estrogen-dominated events that precede ovulation and that favor passage of sperm through the cervix . . .
The concept of the ovarian cycle as a continuum considers that all types of ovarian activity encountered during the reproductive life are responses to different environmental conditions in order to ensure the health of the woman. During the normal ovulatory cycle, a series of sequential events have to occur in a highly synchronized manner. Fertility awareness is useful in helping women to identify the different stages of their reproductive life cycle. Fertility awareness is also a valuable tool in helping women to identify gynecological disorders. Persistence of irregularities within the mucus patterns and the menstrual cycle should be of concern to women presenting with these problems. These irregularities may be due to obstetrical, endocrine, gynecological or iatrogenic disorders. Insight into early pregnancy complications, ovulatory dysfunction and pelvic inflammatory disease can be ascertained from abnormalities within the menstrual cycle and mucus pattern. Thus, fertility awareness will also enable the recognition and early treatment of several metabolic, endocrine and infectious diseases.
Menstrual CyclePhase Length DistributionOvulation Day EstimationElectronic Fertility Monitors
Fehring RJ et al., 2006·J Obstet Gynecol Neonatal Nurs
To determine variability in the phases of the menstrual cycle among healthy, regularly cycling women.
A prospective descriptive study of a new data set with biological markers to estimate parameters of the menstrual cycles. One hundred forty one healthy women (mean age 29 years) who monitored 3 to 13 menstrual cycles with an electronic fertility monitor and produced 1,060 usable cycles of data. Variability in the length of the menstrual cycle and of the follicular, fertile, and luteal phases, and menses. The estimated day of ovulation and end of the fertile phase was the peak fertility reading on the monitor (i.e., the urinary luteinizing hormone surge). Mean total length was 28.9 days (SD = 3.4) with 95% of the cycles between 22 and 36 days. Intracycle variability of greater than 7 days was observed in 42.5% of the women. Ninety-five percent of the cycles had all 6 days of fertile phase between days 4 and 23, but only 25% of participants had all days of the fertile phase between days 10 and 17. Among regularly cycling women, there is considerable normal variability in the phases of the menstrual cycle. The follicular phase contributes most to this variability.
With the collaboration of Italian centres providing services on natural family planning, a prospective study collected data on 2755 menstrual cycles of 193 women. A database was constructed using information on the daily characteristics of cervical mucus and episodes of intercourse. Taking the day of peak mucus as a conventional marker of ovulation, the database identified the length (12 days) and location of a 'window' of potential fertility, the highest level of conception probability being confined to the central five to six days. Univariate analysis provided evidence of the impact on fecundability of the woman's age and the basic infertile pattern of a cycle. Several analytical approaches highlighted the relationship between daily mucus characteristics and levels of fecundability
Fertility AwarenessScientific EvidenceNatural Family PlanningResearch Overview
Assessing the psychological acceptability of technologies designed to assist couples in achieving pregnancy is complex. The current study developed measures relating to the impact of one such technology on 52 couples' relationships, their feelings relating to pregnancy status and their feelings about the technology itself. Pregnancy status and daily logs of sexual activity were recorded for four menstrual cycles, in addition to the completion of acceptability questionnaires. Baseline acceptability measures were more favorable among couples eventually achieving pregnancy. For couples not becoming pregnant, acceptability declined over time and relationships became more strained. Behavioral data clearly indicated a "targeting" and focusing of sexual activity in response to the information displayed by the monitor. Expectations of success, couple disagreements about prior failure and partner communication patterns appear to be related to pregnancy success when using such technology.
Body LiteracyAdolescent Sexual Health ProgramsTeen ProgramsAbstinence Education Outcomes
Open Access
Urgent measures are required to stop the increase in the frequency of pregnancies and sexually transmitted diseases among teenagers. A means of facing this problem is promoting sexual abstinence among youngsters. There are studies that confirm the efficacy of this approach. To show the results of the application of a holistic sexuality program (TeenSTAR) among Chilean teenagers. Students attending basic or high school were divided into a control or study group. The control group (342 students) received the usual education on sexuality given by their schools and the study group (398 students) participated in twelve TeenSTAR sessions lasting 1.5 hours each, given by a trained professor. Assessment of achievements was made using an anonymous questionnaire answered at the start and end of the program. The rates of sexual initiation among control and study groups were 15 and 6.5%, respectively. Among sexually active students, 20% of those in the study group and 9% of those in the control group discontinued sexual activity. A higher proportion of students in the TeenSTAR program retarded their sexual initiation or discontinued sexual activity and found more reasons to maintain sexual abstinence than control students.
Fertility AwarenessElectronic Hormonal Fertility MonitorReturn of FertilityBreastfeeding Protocols
A protocol was developed and evaluated for nonovulating breastfeeding women to determine potential fertility with an electronic hormonal fertility monitor. The amount of required abstinence (i.e., days of potential fertility) through the first menstrual cycle indicated by the fertility monitor was significantly lower (17% of the total days) compared with the amount of abstinence (50% of the total days) indicated by the self-observation of cervical mucus.
Fertility AwarenessBasal Body TemperatureOvulation DetectionClinical Counseling
Advanced practice nurses in primary care settings are often asked to give appropriate advice to couples seeking pregnancy. This article examines the issue of basal body temperature (BBT), a time-honored way to establish the presence of ovulatory cycles, and asks if BBT is an outdated recommendation. The article also reviews the benefits and limitations of recommending BBT to couples seeking pregnancy in light of recent fecundity research.
The objective of the present paper is to review the main results of recent European cycle databases on ovulation detection and determination of the fertile window performed by the women themselves. The ongoing German Long-term Cycle Database currently comprises 32788 prospectively collected cycle charts of 1551 women, the I European Cycle Database (10 countries) 1328 women/19048 cycles, the II European Cycle Database (six countries) 782 women/6724 cycles, and the World Health Organization Database (one European country) 234 women/2808 cycles. The women record cycle parameters (cervical mucus changes, temperature rise, etc.), family planning intention and sexual behavior. With the symptothermal method of natural family planning it has become possible to determine the fertile window in order to avoid pregnancy with a method effectiveness of 0.3%. According to a small sub-study, the ovulation time observed by the women themselves correlates closely with ovulation detected by ultrasound and measurement of luteinizing hormone (correlation within 1 day in 89% of the 62 cycles). Fertility awareness methods can be integrated into the management of sub-fertility. They seem to shorten the time to pregnancy. Self-observation of the fertile window puts women into a position to develop a high level of reproductive competence that could be used much more in different areas than is currently the case.
Menstrual CycleUltrastructureScanning Electron MicroscopyCervical Mucus Patterns
Two main types of cervical mucus have been described oestrogenic and progestative. Each category shows diverse morphological and functional features from the reproductive point of view. Traditionally, this change has been approached by analysing morphological patterns. In fact, a mesh model has been described for cervical mucus, structurally composed of fibrillar subunits with a parallel orientation, together with another model in a characteristic network shape with canalicular units, but the real model is not clear. The objective of our work was to study the different morphological structures of the mucus, as related to the day of follicular rupture (considered as day 0) determined by ultrasound. Cervical mucus samples were obtained from the cervical canal with an ASPIRETTEtrade mark from day -4 to day +1 of the menstrual cycle. Samples were fixed and dried by critical point. The ultrastructure was examined with scanning electron microscopy. The presence of three types of oestrogenic and one type of progestative cervical mucus was confirmed in this period. Our paper shows different types of ultrastructure in the oestrogenic mucus in relation to ovulation, which would help to understand the interaction between male gametes and cervical mucus in migration through the female genital tract.
To develop a new method for estimating the effectiveness of emergency contraception (EC) by using information about previous menstrual cycle length, accounting for the variation in the day of ovulation within the menstrual cycle, and comparing the validity of the new and previous methods. METHOD(S): Secondary analysis of a data set with a biological marker of ovulation and its distribution in the cycle. Based on a sample of cycles with known length and a known biological marker of ovulation, we simulated trials of predetermined EC effectiveness and then calculated estimates of EC effectiveness based on old and new methods. RESULT(S): Under some conditions, all methods produced biased estimates of effectiveness with simulated trials, especially when the actual effectiveness was low. The systematic bias was minimized with the new method. The new method was robust with regard to the distribution of the day of intercourse in women presenting for EC. CONCLUSION(S): Future studies of EC effectiveness should consider both the uncertainty in predicting the day of ovulation and previous cycle length. Our estimates of daily fecundity should be replicated with other data sets.
Reproductive EndocrinologyMenstrual CycleFertility Awareness
Open Access
Our recent study showed a dose-response relationship between environmental tobacco smoke (ETS) and the risk of early pregnancy loss. Smoking is known to affect female reproductive hormones. We explored whether ETS affects reproductive hormone profiles as characterized by urinary pregnanediol-3-glucuronide (PdG) and estrone conjugate (E1C) levels. We prospectively studied 371 healthy newly married nonsmoking women in China who intended to conceive and had stopped contraception. Daily records of vaginal bleeding, active and passive cigarette smoking, and daily first-morning urine specimens were collected for up to 1 year or until a clinical pregnancy was achieved. We determined the day of ovulation for each menstrual cycle. The effects of ETS exposure on daily urinary PdG and E1C levels in a +/-10 day window around the day of ovulation were analyzed for conception and nonconception cycles, respectively. Our analysis included 344 nonconception cycles and 329 conception cycles. In nonconception cycles, cycles with ETS exposure had significantly lower urinary E1C levels (beta = -0.43, SE = 0.08, p < 0.001 in log scale) compared with the cycles without ETS exposure. There was no significant difference in urinary PdG levels in cycles having ETS exposure (beta = -0.07, SE = 0.15, p = 0.637 in log scale) compared with no ETS exposure. Among conception cycles, there were no significant differences in E1C and PdG levels between ETS exposure and nonexposure. In conclusion, ETS exposure was associated with significantly lower urinary E1C levels among nonconception cycles, suggesting that the adverse reproductive effect of ETS may act partly through its antiestrogen effects.
Body LiteracyAdolescent ProgramsTeenSTAR ProgramSchool-Based Interventions
To evaluate the efficacy of an abstinence-centered sex education program in adolescent pregnancy prevention, the TeenSTAR Program was applied in a high school in Santiago, Chile. A total of 1259 girls from a Santiago high school were divided into three cohorts depending on the the 1996 cohort of 425 students, which received no intervention; the 1997 cohort, in which 210 students received an intervention and 213 (control group) did not; and the 1998 cohort, in which 328 students received an intervention and 83 (control group) did not. Students were randomly assigned to control and intervention groups in these cohorts, before starting with the program. We conducted a prospective, randomized study using the application of the TeenSTAR sex education program during the first year of high school to the intervention groups in the 1997 and 1998 cohorts. All cohorts were followed up for 4 years; pregnancy rates were recorded and subsequently contrasted in the intervention and control groups. Pregnancy rates were measured and Risk Ratio with 95% confidence interval were calculated for intervention and control groups in each cohort. Pregnancy rates for the intervention and control groups in the 1997 cohort were 3.3% and 18.9%, respectively (RR: 0.176, CI: 0.076-0.408). Pregnancy rates for the intervention and control groups in the 1998 cohort were 4.4% and 22.6%, respectively (RR 0.195, CI: 0.099-0.384). The abstinence-centered TeenSTAR sex education intervention was effective in the prevention of unintended adolescent pregnancy.
Calendar-based methods are not usually considered effective or useful methods of family planning among health professionals. However, new "high-" and "low"-tech calendar methods have been developed, which are easy to teach, to use, and may be useful in helping couples avoid pregnancy. The low-tech models are based on a fixed-day calendar system. The high-tech models are based on monitoring urinary metabolites of female reproductive hormones. Both systems have high levels of satisfaction. This article describes these new models of family planning and the research on their effectiveness. The author proposes a new algorithm for determining the fertile phase of the menstrual cycle for either achieving or avoiding pregnancy.
"Fertility awareness-based methods" (FAB) of family planning "involve identification of the fertile days of the menstrual cycle, whether by observing fertility signs such as cervical secretions and basal body temperature, or by monitoring cycle days. FAB methods can be used in combination with abstinence or barrier methods during the fertile time" (WHO 2000). Several names have been used to describe this approach to contraception, including "rhythm," "natural family planning" and "periodic abstinence." Fertility awareness-based methods can be used with abstinence from sexual intercourse. Alternatively, they can be used with barrier contraceptives or withdrawal during presumed fertile times. We retrieved and analyzed all randomized controlled trials that examined any fertility awareness-based methods used for contraception. We searched the computerized databases Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, POPLINE, EMBASE, and LILACS (each from its inception to January, 2004) for randomized controlled trials of fertility awareness-based methods. We examined the reference list of each trial as well as that of review articles.
We included all randomized controlled trials in any language that compared any fertility awareness-based methods for contraception with a placebo; another method, including an alternative fertility awareness-based method; or fertility awareness-based methods used in conjunction with another contraceptive. We assessed all titles and abstracts found for inclusion. We evaluated the methodological quality of the trials for potential biases by qualitatively assessing the study design; randomization method; allocation concealment; blinding; premature discontinuation rates; and loss to follow-up rates. Because of methodological weaknesses, we could not enter the trial results in RevMan, calculate measures of association, or aggregate data. Because of poor methods and reporting, pregnancy rates could not be determined. A trial in Colombia found similar numbers of pregnancies among women randomized to the ovulation and symptothermal methods. In contrast, a companion trial in Los Angeles observed more pregnancies in the group assigned to the ovulation method. In the two U.S. trials, recruitment of participants was unexpectedly difficult; this aspect was not mentioned in the report from Colombia. Continuation rates were poor. In the two larger trials, most participants discontinued their assigned method before entering the observation phase of the trial. REVIEWERS' The comparative efficacy of fertility awareness-based methods of contraception remains unknown. Despite intensive training and ongoing support, most participants in these trials discontinued prematurely. Contraceptive methods should be properly evaluated, preferably in randomized controlled trials, before adoption and dissemination.
To test the efficacy of the TwoDay Method, a new fertility awareness-based method of family planning that provides women with simple instructions to identify the days each cycle when they are most likely to become pregnant. Users avoid unprotected intercourse on days when cervical secretions are present on that day or on the day before, to prevent pregnancy.
Prospective, nonrandomized, multicenter study.
Five culturally diverse sites in Guatemala, Peru, and the Philippines. PATIENT(S): Four hundred fifty women, aged 18-39 years, wishing to use a fertility awareness-based method to prevent or delay pregnancy. INTERVENTION(S): Study participants were followed for up to 13 cycles of method use. MAIN OUTCOME MEASURE(S): Life table pregnancy rate. RESULT(S): The first-year pregnancy rate was 3.5 (pregnancies per 100 women/years) with correct use of the method (pregnancies and cycles with no intercourse on identified fertile days), 6.3 with use of a backup method on the fertile days, and 13.7 including all cycles and all pregnancies in the analysis. CONCLUSION(S): The TwoDay Method offers a valuable addition to the services that reproductive health and other programs can offer. Its efficacy compares well with that of other coitus-dependent family-planning methods; it is easy to teach, learn, and use; and it can address the need of women for simple, accurate instructions for identifying their fertile days.
Body LiteracyMenstrual Cycle AwarenessGynecologic ChartingMenstrual Cycle Charting
The goal of an integrative science of women's health is bringing together childbearing with women's health during the lifespan. Enhancing a woman's ability to conceive and maintain a pregnancy is influenced by decisions made well before the beginning of a pregnancy. Identifying ovulatory disorders makes it possible to intervene early in a young woman's childbearing years. Gynecologic charting typically used in natural family planning provides information to the woman and to the healthcare provider that is useful for diagnosis. If young women have a better understanding of fertility and menstrual cycle function, they are in a stronger position to make informed decisions about how they wish to manage their reproductive and sexual health. It may be possible to educate the young woman in health habits that will lead to a healthy pregnancy when she chooses and/or to treat the cause of the ovulatory disorder. This article focuses on polycystic ovary syndrome and hypothalamic dysfunction which can cause menstrual cycle abnormalities in which gynecologic charting is useful in young women.
Baerwald et al. (1) proposed a new model for ovarian follicular development in the human menstrual cycle. They showed additional waves of follicular development in the follicular and luteal phase of normal ovulatory cycles. Although no additional ovulation was observed, the authors speculated that the anovulatory follicles from the additional waves of follicular development may be able to ovulate in the presence of an additional LH surge.
Fertility AwarenessPregnancy Probability ModelsEffectiveness EstimationEfficacy Assessment
Intercourse results in a pregnancy essentially only if it occurs during the 6-day fertile interval ending on the day of ovulation. The strong association between timing of intercourse within this interval and the probability of conception typically is attributed to limited sperm and egg life times. A total of 782 women recruited from natural family planning centres in Europe contributed prospective data on 7288 menstrual cycles. Daily records of intercourse, basal body temperature and vaginal discharge of cervical mucus were collected. Probabilities of conception were estimated according to the timing of intercourse relative to ovulation and a 1-4 score of mucus quality. There was a strong increasing trend in the day-specific probabilities of pregnancy with increases in the mucus score. Adjusting for the mucus score, the day-specific probabilities had limited variability across the fertile interval. Changes in mucus quality across the fertile interval predict the observed pattern in the day-specific probabilities of conception. To maximize the likelihood of conception, intercourse should occur on days with optimal mucus quality, as observed in vaginal discharge, regardless of the exact timing relative to ovulation.
Body LiteracyProfessional Training ProgramsHealthcare Provider EducationDistance Education
Nurses and other health care professionals often have little knowledge of methods of natural family planning (NFP) and do not readily prescribe natural methods for their patients. One reason for this is that little or no information on NFP is provided in nursing or medical schools. The holistic, informational, and integrative nature of NFP fits well with professional nursing practice. A university online distance education NFP teacher training program, which offers academic credit and includes theory, practice, and the latest developments in fertility monitoring, has been developed for health care professionals. Professional NFP services in the United States need to meet worldwide standards and include documenting and assessing pregnancy outcomes, tailoring NFP services to the client or couple, and simplifying them for ease of use in a standard health care practice.
Fertility AwarenessClearplan Easy Fertility MonitorComparison with Hormonal MarkersElectronic Monitors vs Biomarkers
The purpose of this study was to compare the fertile phase of the menstrual cycle as determined by the Clearplan Easy Fertility Monitor (CPEFM) with self-monitoring of cervical mucus. One-hundred women (mean age = 29.4 years) observed their cervical mucus and monitored their urine for estrogen and luteinizing hormone metabolites with the CPEFM on a daily basis for 2-6 cycles and generated 378 cycles of data; of these, 347 (92%) had a CPEFM peak. The beginning of the fertile window was, on average, day 11.8 (SD = 3.4) by the monitor and day 9.9 (SD = 3.0) by cervical mucus (r = 0.43, p < 0.001). The average first day of peak fertility by the monitor was 16.5 (SD = 3.6) and by cervical mucus 16.3 (SD = 3.7) (r = 0.85, p < 0.001). The mean length of the fertile phase by the monitor was 7.7 days (SD = 3.1) and by cervical mucus 10.9 days (SD = 3.7) (t = 12.7, p < 0.001). The peak in fertility as determined by the monitor and by self-assessment of cervical mucus is similar but the monitor tends to underestimate and self-assessment of cervical mucus tends to overestimate the actual fertile phase.
Fertility AwarenessScientific FoundationsBiophysical Properties and Mucus TypingHormonal and Ultrasound Correlation
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
The CREIGHTON MODEL FertilityCare System (CrMS) rests on a decades-long body of research demonstrating that cervical mucus functions as a physiologically regulated biological valve, opening predictably at the periovulatory estrogen rise and closing in the post-Peak phase. Chapter 15 of Hilgers (2004) synthesizes hormonal, ultrasound, cytologic, and biophysical evidence to establish that a woman's external observation of her Peak Day reliably identifies the fertile window, and documents the system's effectiveness data for both achieving and avoiding pregnancy across a five-study meta-analysis of nearly 1,900 couples.
Andrology/Male FactorCriteria and ClassificationMedical TreatmentSurgical Correction
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
Male infertility plays a clinically significant role in a large share of couples who struggle to conceive, yet standard laboratory criteria for semen analysis were designed primarily to predict success with assisted reproduction, not natural fertility. NaProTECHNOLOGY approaches male factor as a diagnosable condition with identifiable root causes, applying medical and surgical options aimed at restoring sperm function and combining that work with fertility-awareness charting to maximize the couple's chances of natural conception.
NaProTECHNOLOGYIntroductory Session StructureBiological Valve MechanismChart Interpretation and Peak Day Identification
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
This 2004 textbook chapter by Thomas W. Hilgers outlines the structure and content of the formal introductory session used to enroll couples in the Creighton Model FertilityCare System (CrMS). It covers the biological foundation of fertility charting, the role of cervical mucus as a biomarker of the reproductive cycle, and the educational framework designed to train couples in systematic, real-time cycle observation.
Fertility AwarenessAchieving- and Avoiding-Related BehaviorUse TaxonomyPregnancy Classification
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
Chapter 13 of Hilgers' NaProTECHNOLOGY textbook establishes a clinical behavioral taxonomy unique to the Creighton Model FertilityCare System, distinguishing between achieving-related and avoiding-related use based on whether a couple's actions increase or decrease the probability of conception. The chapter argues that a "taking a chance" mindset is inherently contraceptive in psychology and must be replaced with intentional, education-grounded behavior that reflects a couple's genuine family planning goals.
Fertility AwarenessCreighton Model FertilityCare SystemCervical Mucus BiomarkersPeak Day Identification
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
The content and sequence of the introductory and follow-up instructional sessions that constitute the formal CrMS education series are outlined, covering observation technique, recording conventions, and the practitioner-client interaction model. Consistent delivery of these core instructions establishes the behavioral competence required for both family planning use and the medical monitoring applications that NaProTECHNOLOGY depends upon.
NaProTECHNOLOGYFertilityCare Practitioner RoleMedical Consultant Referral LetterLong-Distance Consultation Model
Hilgers TW et al., 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
The FertilityCare Practitioner (FCP) is the trained educator and coach who teaches the Creighton Model FertilityCare System to clients, standardizes charting methodology, and serves as the primary data interface between the patient and the NaProTECHNOLOGY physician. Accurate, consistent chart data from FCPs directly determines the quality of biomarker interpretation, targeted intervention timing, and longitudinal outcome assessment throughout medical and surgical care.
NaProTECHNOLOGYParadigm ShiftProspective Cycle ChartingRoot-Cause vs Symptom Suppression
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
NaProTECHNOLOGY (Natural Procreative Technology) is defined as a women's health science that monitors and cooperates with the menstrual and fertility cycles to identify, evaluate, and treat gynecologic and reproductive disorders at their root cause. Unlike suppressive approaches such as hormonal contraception or ART, NaProTECHNOLOGY maintains procreative potential and treats underlying pathology while preserving the human ecology of reproduction.
Fertility AwarenessCervical Mucus ObservationFecundity ResearchCreighton Model
Stanford JB, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
The Mucus Cycle Score, derived from the standardized CrMS daily observations, quantifies cervical mucus quality and quantity across a cycle and correlates with measured estrogen levels and fecundity rates, providing a non-invasive index of reproductive potential. Declining mucus scores are clinically actionable, directing investigation into hypoestrogenism, cervical pathology, or medication effects that reduce cycle fecundity and can be corrected before ART is considered.
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
A CrMS-synchronized hormone sampling protocol is detailed in which progesterone, estradiol, and other reproductive hormones are drawn at cycle-phase-specific time points defined by the charted Peak Day rather than by fixed cycle day, producing a targeted hormone profile that accurately reflects luteal and follicular function. This Peak Day-referenced approach substantially improves the diagnostic sensitivity for luteal phase deficiency, follicular dysfunction, and other endocrine abnormalities that fixed-day sampling routinely misclassifies.
Bone HealthReproductive EndocrinologyFertility AwarenessNaProTECHNOLOGY
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
Chronic anovulation and progesterone or estradiol deficiency identified through CrMS charting represent periods of suboptimal bone accrual in women of reproductive age, because both estradiol and progesterone contribute to skeletal maintenance -- estradiol through suppression of osteoclast activity and progesterone through osteoblast stimulation. NaProTECHNOLOGY uses longitudinal CrMS records of ovulatory status and hormone profiles as a bone-health risk screen, guiding cycle-synchronized bioidentical hormone replacement to restore normal estrogen-progesterone balance and potentially mitigate progression toward osteoporosis in women with chronic cycle-based endocrine deficiencies.
InfertilityFemale Age and FecundabilityMale Age and FertilityProspective Fecundability Studies
Dunson DB et al., 2004·Obstetrics & Gynecology
To estimate the effects of aging on the percentage of outwardly healthy couples who are sterile (completely unable to conceive without assisted reproduction) or infertile (unable to conceive within a year of unprotected intercourse).
A prospective fecundability study was conducted in a sample of 782 couples recruited from 7 European centers for natural family planning. Women aged 18-40 years were eligible. Daily intercourse records were used to adjust for timing and frequency of intercourse when estimating the per-menstrual-cycle probability of conception. The number of menstrual cycles required to conceive a clinical pregnancy and the probability of sterility and infertility were derived from the estimated fecundability distributions for men and women of different ages.
Sterility was estimated at about 1%; this percent did not change with age. The percentage infertility was estimated at 8% for women aged 19-26 years, 13-14% for women aged 27-34 years and 18% for women aged 35-39 years. Starting in the late 30s, male age was an important factor, with the percentage failing to conceive within 12 cycles increasing from an estimated 18-28% between ages 35 and 40 years. The estimated percentage of infertile couples that would be able to conceive after an additional 12 cycles of trying varied from 43-63% depending on age.
Increased infertility in older couples is attributable primarily to declines in fertility rates rather than to absolute sterility. Many infertile couples will conceive if they try for an additional year.
NaProTECHNOLOGYCPRT and CERTProgesterone and Estradiol SupportPeak Day Ovulation Timing
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
Cooperative progesterone and estrogen replacement therapy administers bioidentical hormones in precise synchrony with the woman's CrMS-identified Peak day -- beginning progesterone at P+2 or P+3 and continuing through the luteal phase -- to augment deficient corpus luteum output rather than override the cycle with suppressive dosing. Serial serum progesterone across post-Peak days guides dose titration, and the approach is applied to luteal phase deficiency, recurrent miscarriage, premenstrual syndrome, and postpartum depression while preserving ovulatory function and fertility.
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
Selective hysterosalpingography combined with transcervical fallopian tube catheterization allows both precise diagnosis and non-surgical correction of proximal tubal occlusion, distinguishing true anatomical obstruction from tubal spasm or mucous plugging. In NaProTECHNOLOGY practice, this minimally invasive approach restores tubal patency without laparotomy, preserving natural conception potential in appropriately selected patients.
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
Physiological and psychological stress disrupts hypothalamic GnRH pulsatility via CRH-cortisol pathways, producing downstream impairments in LH and FSH secretion that manifest as anovulation, delayed ovulation, follicular phase prolongation, or luteal phase deficiency -- all of which are documented cycle-by-cycle on the CrMS chart. NaProTECHNOLOGY addresses stress-induced HPO axis dysfunction by identifying the specific cycle-level disorder through charting and targeted hormone profiling, then applying cycle-appropriate ovulation induction and cooperative hormone support alongside correction of the underlying physical or psychological stressor.
Fertility AwarenessDecision-Making FrameworkAchieving vs Avoiding PregnancyResponsible Parenthood and Catholic Teaching
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
Clinical and instructional decision trees guide practitioners through the interpretation of chart findings and the selection of appropriate responses — ranging from continued observation to medical referral — based on pattern recognition and established CrMS criteria. Systematic decision-making protocols reduce practitioner variability, support evidence-based care, and define the threshold at which observed abnormalities warrant further NaProTECHNOLOGY medical evaluation.
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
Pelvic adhesions from prior infection, surgery, or endometriosis restrict tubal motility, occlude the fimbriae, and distort ovarian-tubal relationships, constituting a primary mechanical barrier to natural conception. Microsurgical adhesiolysis performed under NaProTECHNOLOGY protocols achieves tubal patency and restores anatomical relationships, enabling natural pregnancy in a substantial proportion of cases that would otherwise be directed to IVF.
Fertility AwarenessCreighton Model FertilityCare SystemAchieving-Related Pregnancy RateDemographic Effectiveness Research
Hilgers TW et al., 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
Pregnancy achievement rates among couples using the CrMS to target fertile days are analyzed by cycle type, reproductive history, and duration of use, demonstrating the system's capacity to accommodate irregular and abnormal cycles without reducing its fertility-targeting utility. These data are foundational to NaProTECHNOLOGY's application in infertility management, establishing that the CrMS identifies fertile windows even in subfertile populations with disrupted cycle parameters.
Fertility AwarenessCervical Mucus ScoringCreighton Model Cycle ClassificationBody Literacy
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
A quantitative taxonomy for classifying the cervical mucus cycle is established, using standardized descriptors for mucus type, quantity, consistency, and Peak Day timing to produce objectively comparable cycle profiles across patients and study populations. This classification system is indispensable to NaProTECHNOLOGY research and clinical correlation, as it enables the linkage of specific mucus pattern anomalies to underlying endocrine pathology.
Fertility AwarenessCreighton Model chartingVaginal Discharge Recording SystemNaProTECHNOLOGY cycle chart interpretation
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
The CrMS charting system is explained in full, including the stamp-based notation for recording mucus characteristics, bleeding, and dry days on the standardized chart, and the conventions for identifying the Peak Day. Accurate chart reading is the foundational clinical skill for NaProTECHNOLOGY practitioners, as the chart provides the biomarker timeline against which hormone profiles and pathology are interpreted.
Fertility AwarenessCreighton Model FertilityCare SystemContinuous Mucus DischargeEssential Sameness Pattern and Point of Change
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY
Women with persistent or continuous vaginal discharges — including those from chronic cervicitis, hormonal imbalance, or other gynecologic sources — present a distinct charting challenge, and this chapter provides CrMS-specific protocols for distinguishing pathologic discharge from fertile-quality cervical mucus. Correct identification is clinically critical because misclassification distorts cycle interpretation, effectiveness calculations, and the hormone-assessment timeline.
Fertility AwarenessResearch Methodology
Open Access
Although there has been growing concern about the effects of environmental exposures on human fertility, standard epidemiologic study designs may not collect sufficient data to identify subtle effects while properly adjusting for confounding. In particular, results from conventional time to pregnancy studies can be driven by the many sources of bias inherent in these studies. By prospectively collecting detailed records of menstrual bleeding, occurrences of intercourse, and a marker of ovulation day in each menstrual cycle, precise information on exposure effects can be obtained, adjusting for many of the primary sources of bias. This article provides an overview of the different types of study designs, focusing on the data required, the practical advantages and disadvantages of each design, and the statistical methods required to take full advantage of the available data. We conclude that detailed prospective studies allowing inferences on day-specific probabilities of conception should be considered as the gold standard for studying the effects of environmental exposures on fertility.
Fertility AwarenessTime to PregnancySubfertility DefinitionSurvival Analysis
The likelihood of spontaneous conception in subsequent cycles is important for a balanced management of infertility. Previous studies on time to pregnancy are mostly retrospective and biased because of exclusion of truly infertile couples. The study aim was to present a non-parametric estimation of cumulative probabilities of conception (CPC) in natural family planning (NFP) users illustrating an ideal of human fertility potential. A total of 346 women was observed who used NFP methods to conceive from their first cycle onwards. The couples practising NFP make optimal use of their fertility potential by timed intercourse. The CPC were estimated for the total group and for couples who finally conceived by calculating Kaplan-Meier survival rates. A total of 310 pregnancies occurred among the 346 women; the remaining 36 women (10.4%) did not conceive. Estimated CPC for the total group (n = 340 women) at one, three, six and 12 cycle(s) were 38, 68, 81 and 92% respectively. For those who finally conceived (truly fertile couples, n = 304 women), the respective pregnancy rates were 42, 75, 88 and 98% respectively. Although the numbers of couples in both groups were similar, the impact of age on time to conception, as judged by the Wilcoxon test, was less in the truly fertile than in the total group. Most couples conceive within six cycles with timed intercourse. Thereafter, every second couple is probably either subfertile or infertile. CPC decline with age because heterogeneity in fecundity increases. In the subgroup of truly fertile couples, an age-dependent decline in CPC is statistically less obvious because of high homogeneity, even with advancing age.
Natural Family Planning (NFP) requires periodic abstinence and partner cooperation to prevent pregnancy. The aim of this study was to learn about the effects of modern NFP methods on marital relationships.
Descriptive survey. Questionnaires were mailed to 1,400 randomly selected couples known to use NFP and residing in the United States of America; 334 couples (24%) responded. Content analysis was used to identify meanings and themes. Numeric analyses were used to determine frequencies. Nearly two-thirds of the qualitative comments were positive. Four themes were identified relationship enhancements, knowledge improvements, spirituality enrichments, and method successes. Three negative strained sexual interactions, worsened relationships, and method problems. Although about one-fourth of the comments indicated that NFP presented challenges, the majority (74%) found it beneficial, often resulting in stronger bonds, better communication, and improved knowledge. NFP had more positive than negative effects and its use warrants further consideration.
Contraception/ComparisonYuzpe Method MechanismEstimation UncertaintyOvulation Day Estimation
A study was conducted to determine the accuracy and reliability of the Home Ovarian Monitor for measuring estrone glucuronide (E1G) and pregnanediol glucuronide (PdG) during ovulatory cycles as a means of monitoring ovarian activity. Approximately 60 ovulating women in three centres collected timed specimens of urine (3h or more) for a total of six cycles each. The women measured the E1G and PdG excretion per 24h in their urine specimens using the Monitor. A local laboratory using the Monitor also measured the excretion. Urine specimens from 18 to 19 cycles were sent frozen to the WHO Reference Laboratory in London where they were analysed for E1G and PdG by the Monitor and by radioimmunoassay (RIA). The correlation coefficients between the Monitor and radioimmunoassay results obtained in London were better than 0.84 in 80% of the cycles. A urine bias caused the Monitor E1G results to be higher than those obtained by radioimmunoassay but the daily patterns were the same. In 50% of the cycles, this bias caused a delay of up to 3 days in identifying the beginning of the E1G rise compared with radioimmunoassay. Timing of the preovulatory E1G peak and the postovulatory PdG rise agreed within the experimental errors of the two systems. The study confirmed that women using the Monitor at home obtained results that were as accurate as those obtained by laboratory procedures. Careful supervision was required to maintain laboratory levels of quality control and interpretation of results.
NaProTECHNOLOGYCervical Mucus ObservationsCreighton ModelDay-Specific Conception Probability
To assess the day-specific and cycle-specific probabilities of conception leading to clinical pregnancy, in relation to the timing of intercourse and vulvar mucus observations. This was a retrospective cohort study of women beginning use of the Creighton Model Fertility Care System in Missouri, Nebraska, Kansas, and California. Data were abstracted from Creighton Model Fertility Care System records, including women's daily standardized vulvar observations of cervical mucus discharge, days of intercourse, and clinically evident pregnancy (conception). Established statistical models were used to estimate day-specific probabilities of conception. Data were analyzed from 1681 cycles with 81 conceptions from 309 normally fertile couples (initially seeking to avoid pregnancy) and from 373 cycles with 30 conceptions from 117 subfertile couples (who were initially trying to achieve pregnancy). The highest probability of pregnancy occurred on the peak day of vulvar mucus observation (.38 for normally fertile couples and.14 for subfertile couples). The probability of pregnancy was greater than.05 for normally fertile couples from 3 days before to 2 days after the peak, and for subfertile couples from 1 day before to 1 day after the peak. The cycle-specific probability of conception correlated with the quality of mucus discharge in normally fertile couples but not in subfertile couples. Standardized vulvar observations of vaginal mucus discharge identify the days with the greatest likelihood of conception from intercourse in normal fertility and subfertility and provide an indicator of the overall potential for conception in a given menstrual cycle in normal fertility.
A discrepancy exists between the interest in modern methods of natural family planning (NFP) and their actual use in developed countries. To explore reasons for this discrepancy, we analyzed data from a questionnaire administered to postpartum women in Berlin (n = 223) and Cracow (n = 233). Knowledge of NFP, past use of NFP and expected effects of abstinence on the partnership were independently associated with interest in using NFP, but not the choice to do so among those interested. Desire for future pregnancies, importance of religious belief and location in Cracow were independently associated with the choice to use NFP among those interested. Perceived accuracy of observation to identify the fertile time and acceptance of own body were independently associated with both interest in and choice to use NFP. Frequency of intercourse had no effect on interest. These results suggest that increased access and cultural support would likely lead to a higher prevalence of NFP use in developed countries.
Physicians who counsel women for preconception concerns are in an excellent position to give advice to couples regarding the optimal timing of intercourse to achieve pregnancy. The currently available evidence suggests that methods that prospectively identify the window of fertility are likely to be more effective for optimally timing intercourse than calendar calculations or basal body temperature. There are several promising methods with good scientific bases to identify the fertile window prospectively. These include fertility charting of vaginal discharge and a commercially available fertility monitor. These methods identify the occurrence of ovulation clinically and also identify a longer window of fertility than urinary luteinizing hormone kits. Prospectively identifying the full window of fertility may lead to higher rates of conception. Proper information given early in the course of trying to achieve pregnancy is likely to reduce time to conception for many couples, and also to reduce unnecessary intervention and cost.
The (PD) peak day of cervical mucus is an important biologic marker for the self-determination of the optimal time of fertility in a woman's menstrual cycle. The purpose of this article is to provide evidence (literature and empiric) for the accuracy of the PD of cervical mucus as a biologic marker of peak fertility and the estimated day of ovulation. An analysis of data from four published studies that compared the self-determination of the PD of cervical mucus with the urinary luteinizing hormone (LH) surge was conducted. The four studies yielded 108 menstrual cycle charts from 53 women participants. The 108 cycles ranged in length from 22 to 75 days (mean 29.4 SD 6.0). Ninety-three of the 108 cycles had both an identified PD and LH surge. Data charts showed that 97.8% of the PD fell within +/-4 days of the estimated day of ovulation. Use of a standardized mucus cycle scoring system indicated that the peak in cervical mucus ratings was highest on the day of the LH surge. Self-determination of the PD of cervical mucus is a very accurate means of determining peak fertility and a fairly accurate means of determining the day of ovulation and the beginning of the end of the fertile time.
Fertility AwarenessDaily Conception ProbabilityDuration and TimingFecundability Estimation
This multicenter study has produced a database of 7017 menstrual cycles contributed by 881 women. It provides improved knowledge on length and location of the "fertile window" (identified as of up to 12 days duration) and the patterns and level of daily conception probability. The day of ovulation was identified in each cycle from records of basal body temperature and mucus symptoms. By referencing days of intercourse to the surrogate ovulation markers, estimates of daily fecundability were computed either directly or by the Scwartz model, both for single and multiple acts of intercourse in the fertile window. The relationship between coital pattern and fecundability has been explored. Univariate analysis underlines the significant link with fecundability only of the woman's reproductive history.
Fertility AwarenessStandard Days MethodProspective TrialsPregnancy Rates
The Standard Days Method is a fertility awareness-based method of family planning in which users avoid unprotected intercourse during cycle Days 8 through 19. A prospective multi-center efficacy trial was conducted to test, in a heterogeneous population, the contraceptive efficacy of the Standard Days Method. A total of 478 women, age 18-39 years, in Bolivia, Peru, and the Philippines, with self-reported cycles of 26-32 days, desiring to delay pregnancy at least one year were admitted to the study. A single decrement multi-censoring life table analysis of the data indicate a cumulative probability of pregnancy of 4.75% over 13 cycles of correct use of the method, and a 11.96% probability of pregnancy under typical use. This article describes the study and the results. Results suggest that despite its requirement that couples modify their sexual behavior when the woman is fertile, the Standard Days Method provides significant protection from unplanned pregnancy and is acceptable to couples in a wide range of settings.
Fertility AwarenessHormone MonitoringUser Experience and ComplianceLongitudinal Survey
A new contraceptive technology may advance the science of family planning but may do little to affect health if potential users do not deem it an acceptable method. The authors conducted an acceptability study of a newly developed contraceptive method--personal hormone monitoring. A sample of 480 English volunteers present at the 6th month of a 13-month longitudinal study completed surveys regarding their attitudes toward a personal hormone monitor for the purpose of contraception. The authors used the participants' responses to determine (a) the extent to which the participants accepted the monitor, (b) how their ratings of acceptability changed over time, (c) the extent to which contextual variables predicted changes in acceptability over time, and (d) whether those contextual variables predicted final acceptability of the monitor. Results suggested that no single method of family planning is best for everyone and specified the people for whom personal hormone monitoring may be most suitable.
Contraception/ComparisonFactors Influencing ComplianceNatural Family Planning SatisfactionMethod-Specific Concerns
den Tonkelaar D et al., 2002·Eur J Contracept Reprod Health Care
To study the extent to which variation in satisfaction with a birth control method is explained by variation in perceived physical and psychological effects. A population survey among 1466 German women was carried out. Within the overall sample, 1303 women had ever used oral contraceptives, 996 had relied on condoms, 342 had ever used intrauterine devices (IUD), 428 had used natural family planning and 139 women were sterilized. For each method a woman had ever used, she answered questions about satisfaction with the method, concerns about getting pregnant or suffering health risks during use, ease of use, changes in sexual relationship, relationship with the partner and mood. Past and current users of oral contraceptives and IUDs and sterilized women additionally reported changes in menstrual bleeding. Variation in satisfaction was, for a large part, explained by variation in health concerns among oral contraceptive users, by variation in perceived changes in the quality of the sexual relationship among condom users, by perceived ease of use among IUD users and sterilized women, and by variation in pregnancy concern among natural family planning users. Counselling about these perceived experiences is most likely to result in greater satisfaction and therefore improved compliance.
NaProTECHNOLOGYUser MaterialsCreighton Model SystemCharting Education
Focus group research was conducted in four countries to understand how couples who use calendar methods determine when they are at risk of pregnancy, what behavior they adopt during the fertile phase, and whether or not they are satisfied with their method. Calendar and periodic abstinence method users do not all know how to make correct calendar calculations of the fertile period, report being sexually active during the fertile period, and desire a more comprehensive approach to sexual behavior during the fertile period. Men's roles in the methods should be enhanced, and credible resources in the community should be enlisted to improve education, information, and communication.
Fertility AwarenessBiomarker ComparisonUltrasound and Hormonal IndicesCervical Mucus and Urinary Hormones
To improve prediction of ovulation in normal cycles. Collection of women's characteristics and their menstrual cycles. Monitoring and analysis of time relationships between several transvaginal ultrasonography, cervical mucus, basal body temperature, urinary luteinising hormone, and ratio of urinary oestrogen to progesterone metabolites. Each of eight natural family planning clinics was to study 12 women for at least three cycles. One hundred and seven normally fertile and cycling women aged 18 to 45. Daily measurements of urinary luteinising hormone, follicle stimulating hormone, oestrone-3-glucuronide and pregnanediol-3alpha-glucuronide. Basal body temperature recording and cervical mucus checking. Transvaginal ultrasound examination of the ovaries. Delays between the expected day of ovulation according to the luteinising hormone peak or to ultrasound evidence and the expected days according to the other indices of ovulation. Ultrasonography was able to show evidence of ovulation in 283 out of 326 cycles. The average time lag between luteinising hormone peak and ultrasound evidence was less than one day (+0.46) but premature and late luteinising hormone-expected date of ovulation were observed in nearly 10% and 23% of cycles, respectively. Basal body temperature rise was observed in 98% of cycles. Cervical mucus peak symptom, rapid drop in the ratio of urinary metabolites, and luteinising hormone initial rise were all close to ultrasonographic evidence in more than 72% of cycles. For accuracy and practical reasons, the cervical mucus peak symptom, the ratio of urinary metabolites and luteinising hormone initial rise might be better indices of ovulation than the luteinising hormone peak.
To compare clinical accuracy and ease of use for several of the new rapid one-step home urinary LH detection kits compared with the preexisting OvuQuick brand LH detection kit (designated as the standard).
Prospective cohort study.
University-based infertility clinic. PATIENT(S): All women undergoing intrauterine inseminations at the clinic, regardless of infertility diagnosis, were offered enrollment during a 28-month study period. INTERVENTION(S): Each participant was supplied three one-step test kits (OvuQuick One-Step, ClearPlan Easy, and SureStep) in addition to a multistep OvuQuick test kit and instructed to run the tests in parallel on the same urine sample and to record the results. Urine testing was performed every 12 hours, beginning 3 days before the anticipated onset of an LH surge, and continued with the one-step kits every 12 hours for 48 hours after the surge was first detected by OvuQuick. Subjects also completed questionnaires evaluating the use of each test kit. MAIN OUTCOME MEASURE(S): Correlation of LH surge detection by one-step kits in comparison to surge detection by OvuQuick. Satisfaction and ease of use questionnaires. RESULT(S): Sixty-three volunteers returned useable data, from which 81 evaluable cycles were analyzed. The majority of patients found the newer one-step kits to be easier to use and less time consuming than OvuQuick. The three one-step kits detected the LH surge within +/- one testing period (+/-12 hours) of detection by OvuQuick 68%-84% of the time. OvuQuick One-Step, with modified instructions allowing for an equal color intensity in the test and reference areas, had the highest correlation with OvuQuick (84%). However, with a study power (alpha = 0.05, beta = 0.10) sufficient to detect a 10% difference between Ovuquick and each one-step kit, all one-step kits were statistically equivalent to each other. There was no cycle in which a one-step kit detected a positive LH surge but OvuQuick did not. CONCLUSION(S): One-step urinary LH kits are easier for patients to use than a multistep home urinary LH kit and have reasonable correlation with the multistep kit when used clinically for timing artificial inseminations.
NaProTECHNOLOGYPractitioner TrainingNFP Instruction MethodsNFP Practitioner Role
Barron ML et al., 2001·J Obstet Gynecol Neonatal Nurs
The Creighton Model system of natural family planning (NFP) is useful in achieving pregnancy, avoiding pregnancy, and detecting some gynecologic disorders. NFP practitioners support the client in using NFP. Because the effectiveness of NFP is related to the teaching process and to teacher expertise, clients choosing NFP may be best served by referral to a certified NFP practitioner for instruction.
Body LiteracyHealthcare Provider KnowledgeProvider Promotion of NFPChild Spacing Methods
The purpose of this study was to describe and assess certified nurse-midwives' (CNMs) knowledge and promotion of two modalities for child spacing, natural family-planning (NFP) and the lactational amenorrhea method (LAM). One thousand two hundred CNMs were randomly selected from a national membership list and mailed a 24-item questionnaire on NFP and LAM. Of the 514 respondents (42.8% return rate), 450 (87.5%) were currently practicing as CNMs. Respondents had an average age of 46 years, with an average of 10 years of practice. CNMs ranked NFP as the ninth most used and the eighth most effective family-planning method in their practice, with an average perceived method-effectiveness of 88% and use-effectiveness of 70%. Although most respondents felt somewhat prepared during their education program to provide NFP, only 22% would offer NFP as a family-planning option for child spacing.
This paper considers the concept of consumer acceptance of medical products and its importance to successful healthcare provision. The critical dimensions ('domains') of acceptance for a product designed to assist family planning, and the importance of using high-quality psychometric scales to assess these domains, are discussed. Qualitative and quantitative data from acceptance studies with a personal contraceptive monitor, PERSONA, are presented. These data indicate that the monitor is user-friendly and acceptable to couples, and underline the importance of user acceptability for home monitors designed to assist family planning--including those used for conception purposes.
The objective of this effort was to assess the use and efficacy of the Lactational Amenorrhea Method (LAM) with reduced numbers of client-provider contacts. A co-sponsored multicenter study of LAM was performed to test the efficacy and acceptability of the method under "post-marketing" conditions, with investigator-initiated at the time of intake and then again at month 7 of postpartum. These data are assumed to provide an assessment of LAM's use, efficacy, and performance that more closely reflects the prevailing conditions of these populations during normal use. Three hundred and sixty-two subjects were recruited through centers that had participated in the previous, more contact-intensive studies. Using a cooperatively developed protocol, data were gathered prospectively on at least 10 and up to 50 LAM acceptors at nine sites, and entered and cleaned on site. Data were further cleaned and analyzed at the Georgetown University Institute for Reproductive Health (IRH) and the Department of Nutrition at the University of Connecticut. Using country-level and pooled data, descriptive statistics and life tables were produced. LAM efficacy in this sample is 100% because there were no pregnancies at any of the participating sites. Satisfaction with the method was high, and the rate of continuation on to another method after LAM was 66.7% at 7 months postpartum. Of the women who had never used family planning prior to LAM, 63.0% went on to use another method of family planning in a timely manner. LAM can be highly effective as an introductory postpartum family planning method when offered in a variety of cultures, health care settings, and industrial and developing country locales. Under conditions of limited client-provider contact, LAM remains effective and leads to acceptance of another method by about two-thirds of the acceptors. Women are able to use LAM effectively without extensive counseling or follow-up, with a high level of user satisfaction.
To assess the reliability of the most widely used clinical methods for predicting or confirming ovulation. We monitored spontaneous cycles in 101 infertile women using basal body temperature (BBT), transvaginal ultrasound, a urinary stick system for LH surge, and three serum progesterone measurements in the midluteal phase. Transvaginal ultrasound monitoring was standard for ovulation detection and sensitivity. We calculated specificity and accuracy of each method compared with that standard. Follicular development and ultrasound evidence of ovulation were confirmed in 97 of 101 cycles (96%). Urinary LH surge preceded follicular rupture assessed by ultrasonography in all cycles and showed concordance with ultrasound-evidenced ovulation in 98 of 101 cases. The timing of BBT nadir had wide variability, and BBT and ultrasonography agreed in a similar percentage of cases (74%). Midluteal serum progesterone assessments showed ovulatory values in 93 subjects, and ovulation was concordant with ultrasonography in 90 subjects. Urinary LH was accurate in predicting ovulation with ultrasonography as the standard for detection, but time varied widely. The nadir of BBT predicted ovulation poorly. The BBT chart was less accurate for confirming ovulation, whereas a single serum progesterone assessment in midluteal phase seemed as effective as repeated serum progesterone measures.
To provide specific estimates of the likely occurrence of the six fertile days (the "fertile window") during the menstrual cycle.
Prospective cohort study. 221 healthy women who were planning a pregnancy. The timing of ovulation in 696 menstrual cycles, estimated using urinary metabolites of oestrogen and progesterone. The fertile window occurred during a broad range of days in the menstrual cycle. On every day between days 6 and 21, women had at minimum a 10% probability of being in their fertile window. Women cannot predict a sporadic late ovulation; 4-6% of women whose cycles had not yet resumed were potentially fertile in the fifth week of their cycle. In only about 30% of women is the fertile window entirely within the days of the menstrual cycle identified by clinical guidelines-that is, between days 10 and 17. Most women reach their fertile window earlier and others much later. Women should be advised that the timing of their fertile window can be highly unpredictable, even if their cycles are usually regular.
Fertility AwarenessStandard Days MethodProspective StudiesDeveloping Country Populations
Burkhart MC et al., 2000·International Family Planning Perspectives
Mayan couples in Guatemala have very low rates of contraceptive use but have long expressed an interest in natural family planning methods. A simple calendar rhythm method of family planning was tested among 301 couples living in two departments in the Guatemalan highlands. The method requires couples to keep track of the womans menstrual cycle using a calendar and a necklace as a reminder and to abstain from intercourse on days 9-19 of each cycle. Participants--most of whom were Mayan had had fewer than 7 years of schooling and had never used a contraceptive method--received instruction in how to use the method and were followed up for 1 year. Data were analyzed using life tables. 79% of couples successfully completed 1 year of use. Any difficulties they encountered with the method (i.e. with using the calendar or necklace or abstaining from intercourse for 11 days each month) occurred early in the study and after 1 year couples were highly satisfied with the method. 11% of couples conceived during the study and one-third of this group said that they had not had relations during the womans fertile period. Among the 31 couples who discontinued method use for reasons other than pregnancy the principal reason was personal factors. The only demographic characteristic that was significantly associated with continuation and pregnancy rates was age. A fairly simple natural method is potentially effective and highly acceptable among the Mayan population of Guatemala. (authors)
Fertility AwarenessHormone Monitoring DevicesFertility Monitor UseUser Profiles and Satisfaction
Janssen CJ et al., 2000·Eur J Contracept Reprod Health Care
The primary objective of this study was to investigate the profile of the Dutch Persona user and her opinion about this relatively new way of natural birth control. The results of the study were used to draw conclusions for the suitability for Persona as a contraceptive method. Data from 137 users of the device were obtained from structured questionnaires. The 'Persona woman' is typically in a steady relationship, highly educated and has an above-average income. She wants to have a contraceptive method with no side-effects and desires children in the future. She is therefore looking for information about her own cycle. It is remarkable that one in four women uses the system to help in planning a pregnancy instead of avoiding one. Persona seems to be a welcome alternative for natural family planning and for couples who have no absolute negative attitude towards a(nother) child, but want to postpone their first pregnancy or to space pregnancies. The method is not reliable enough to be used as the only contraceptive method when a couple absolutely wants to prevent a pregnancy. Another conclusion that can be drawn is that the method improves fertility awareness.
Nowadays, there is an increasing interest in natural family planning methods. The biological basis for the application of natural family planning methods is the recognition of ovulation and, more extensively, of the fertile period. Several studies in the past decade have shown the efficacy of these methods and that the main cause of failure was either a conscious departure from the rules of the method or erroneous application of the method. Another problem affecting natural family planning that has been highlighted is the relatively high discontinuation rate. These features are probably due to low compliance in applying the natural family planning rules, which may be too demanding for a number of couples. In this review, there are comments on the application of natural family planning methods, the discontinuation rates and the failure of the method due to mistakes in the studies carried out in the past 15 years. Steps that can be taken to limit mistakes and discontinuity are also addressed.
NaProTECHNOLOGYUser Education and ComplianceFollow-up and RetentionUser Demographics
Effective use of natural family planning is strongly dependent upon adequate instruction. The Creighton Model Fertility Care System (CrMS) has a standardized protocol for instruction of new users that includes individual follow-up visits in the first year of use. This study evaluated the number of follow-up visits completed by new CrMS users from eight CrMS centers in the United States. Four follow-up visits were completed by 75.7% of women. Women who continued instruction were more likely to be educated, Catholic, and white, and to have a more challenging reproductive status (discontinuing oral contraceptives, or breastfeeding). These results suggest that the number of follow-up visits needed varies among new CrMS users. Future research should address the optimal length of instruction for adequate use of the CrMS by women with different characteristics and needs.
Fertility AwarenessStandard Days MethodTheoretical EffectivenessIdentification Methods
A significant number of women worldwide use periodic abstinence as their method of family planning. Many of them use some type of calendar-based approach to determine when they should abstain from unprotected intercourse to avoid pregnancy; yet they often lack correct knowledge of when during their menstrual cycle they are most likely to become pregnant. A simple method of natural family planning (NFP) based on a fixed formula to define the fertile window could be useful to these women. This article reports the results of an analysis of the application of a fixed formula to define the fertile window. A large existing data set from a World Health Organization study of the Ovulation Method was used to estimate the theoretical probability of pregnancy using this formula. Information about the variable probability of pregnancy on different cycle days relative to ovulation also was considered in the analysis. Results suggest that a fixed formula in which days 8-19 of the menstrual cycle are considered to be the fertile window would provide the appropriate basis of a simple, effective, family planning method.
Fertility AwarenessPhysician KnowledgeHealthcare Provider AwarenessNatural Family Planning Effectiveness
To assess physicians' knowledge and practices of modern methods of natural family planning. A questionnaire was mailed to 840 physicians selected randomly from Missouri state licensing records for obstetrics-gynecology, family practice, general practice, and general internal medicine. The response rate was 65%. A total of 375 physicians (69% of respondents) saw women for reproductive issues. About half (46%) of physicians reported that they mentioned natural family planning to at least some women when discussing family planning issues. Observing vaginal discharge of cervical mucus was discussed by 40% of physicians in the context of avoiding pregnancy and by 36% of physicians in the context of helping a couple achieve pregnancy. Twenty-two percent of physicians estimated the best possible effectiveness of natural family planning to avoid pregnancy to be greater than 90%, and 35% estimated the actual effectiveness to avoid pregnancy to be greater than 70%. (The threshold rates of 90% best possible effectiveness and 70% actual effectiveness were chosen to be somewhat less than those reported in medical literature.) Physicians who gave higher estimates of effectiveness of natural family planning and physicians who were aware of an instructor in their community were more likely to provide women with relevant information about natural family planning. Most physicians, especially those unaware of availability of instructors in their areas, underestimate the effectiveness of natural family planning and do not give information about modern methods to women.
Body LiteracyPhysician Knowledge and PracticesCounseling GapsNFP Effectiveness Perception
In Brief Objective To assess physicians' knowledge and practices of modern methods of natural family planning. Methods A questionnaire was mailed to 840 physicians selected randomly from Missouri state licensing records for obstetrics-gynecology, family practice, general practice, and general internal medicine. Results The response rate was 65%. A total of 375 physicians (69% of respondents) saw women for reproductive issues. About half (46%) of physicians reported that they mentioned natural family planning to at least some women when discussing family planning issues. Observing vaginal discharge of cervical mucus was discussed by 40% of physicians in the context of avoiding pregnancy and by 36% of physicians in the context of helping a couple achieve pregnancy. Twenty-two percent of physicians estimated the best possible effectiveness of natural family planning to avoid pregnancy to be greater than 90%, and 35% estimated the actual effectiveness to avoid pregnancy to be greater than 70%. (The threshold rates of 90% best possible effectiveness and 70% actual effectiveness were chosen to be somewhat less than those reported in medical literature.) Physicians who gave higher estimates of effectiveness of natural family planning and physicians who were aware of an instructor in their community were more likely to provide women with relevant information about natural family planning. Conclusion Most physicians, especially those unaware of availability of instructors in their areas, underestimate the effectiveness of natural family planning and do not give information about modern methods to women Most physicians underestimate the effectiveness of natural family planning, and half do not include it among family planning options discussed with their patients.
To evaluate pregnancy probabilities during use of the Creighton Model Fertility Care System (CrMS). Couples who began use of the CrMS were entered into this observational cohort study. Follow-up included detailed reviews of use of the CrMS. Pregnancy probabilities were calculated with both net and gross life-table analysis through 18 months. A natural family planning service delivery program based at an urban hospital in Houston, Tex. A group of 701 couples who received instruction in the CrMS were entered into the study. Most couples (93%) were engaged or married. Most women were white (83%), between the ages of 20 and 34 years (88%), and college graduates (58%). Pregnancies were classified based on a detailed evaluation involving the pregnant woman (usually with her partner). At 12 months, the following net pregnancy probabilities were found per 100 method-related pregnancies, 0.14; pregnancies caused by user and/or teacher error, 2.72; pregnancies caused by achieving-related behavior (genital contact during a time known to be fertile), 12.84; unresolved pregnancies, 1.43; and total pregnancies, 17.12. Pregnancy probabilities were similar when stratified by the following uncomplicated regular cycles, long cycles, discontinuing oral contraceptives, breastfeeding, and other. Pregnancy probabilities of the CrMS compare favorably with those of other methods of family planning. Most pregnancies result from genital contact during a known fertile time. Women need not have regular cycles to use the CrMS successfully.
Contraception/ComparisonSatisfaction SurveysPhysical and PsychologicalComparison with Other Methods
User satisfaction and the physical and psychological effects of five commonly used contraceptive methods were investigated in a population survey among 1466 West German women. The focus was on effects attributed by current and past users to these methods, rather than objectively assessed effects, to shed further light on personal experiences that are highly relevant to the user but often remain unknown to prescribers and unreported in the medical literature. Within the overall sample, 1303 women were surveyed concerning their current or past use of oral contraceptives (OC), 996 regarding condoms, 342 with respect to intrauterine devices (IUD), 428 in regard to natural family planning (NFP), and 139 in relation to sterilization (respondents completed questions about each method used). It emerged that satisfaction was greatest with sterilization (92% of users), followed by OC (68% of ever users), IUD (59%), NFP (43%), and condoms (30%). Almost one in three NFP users had experienced an unwanted pregnancy during use of this method, as compared with one in 20 OC and condom users. The majority of users reported no mood changes during use of the methods studied. The percentages reporting negative mood changes (various items were scored) were up to 16% among OC users, 23% among condom users, and 30% among NFP users. The latter observations suggested that subjective side effects of a contraceptive agent on mood generally reflected, at least in part, the user's sense of confidence in the method concerned (notably, with regard to efficacy and safety). Oral contraceptives, IUD, and sterilization had a broadly positive impact on sex life, whereas that of condoms was often negative. Whereas OC users often reported less heavy and painful menstruation (in up to 56% of cases), IUD were associated with heavier, prolonged, and more painful menstruation (in up to 65% of cases), as also was sterilization, although to a lesser extent (in up to 32% of cases). Overall, the study findings indicated that OC and sterilization had less negative impact on physical and psychological functioning than the other methods studied, in contrast to what the general public often believes.
Small hand-held microscopes have been developed for self-observation of salivary ferning patterns to detect the fertile time of a woman's menstrual cycle. The purpose of this study was to evaluate one such microscope, the Lady Free Biotester, by comparing it with the self-observation of cervical-vaginal mucus and with the self-detection of luteinizing hormone (LH) in the urine. Twelve natural family planning teachers (average age 34.6 years) observed their cervical-vaginal mucus, tested their urine for LH, and observed salivary and cervical-vaginal mucus ferning patterns (with the Lady Free Biotester) for two menstrual cycles. Data indicated that there was a strong correlation between the LH in the urine and the peak in self-observed cervical-vaginal mucus ferning (r = 0.99, p < or = 0.001) and salivary ferning (r = 0.98, p < or = 0.001). However, it was difficult to assess the beginning and end of the fertile time based on the salivary ferning patterns. Further testing of salivary ferning patterns is recommended before widespread use of these devices for family planning.
To evaluate the use effectiveness of Creighton Model (CrM) NaProEducation Technology for avoiding pregnancy. CrM is a medical model of natural procreation education that is a fully standardized modification of the Billings ovulation method. This system has been used as a means to avoid pregnancy and has been prospectively evaluated in five use effectiveness studies. A prospective life-table analysis of the five studies (meta-analysis) was undertaken, yielding both net and gross rates. Discontinuation rates were also calculated. These studies were conducted at CrM centers in Omaha, St. Louis, Wichita, Houston, and Milwaukee. A total of 1,876 couples used CrM NET for a total of 17,130.0 couple months of use. The method and use effectiveness rates for avoiding pregnancy were 99.5 and 96.8 at the 12th ordinal month and 99.5 and 96.4 at the 18th ordinal month, respectively. The discontinuation rate was 11.3% at the 12th ordinal month and 12.1% at the 18th ordinal month. CrM is highly effective as a means of avoiding pregnancy in both its method and use effectiveness. The method effectiveness has remained stable over the years of the studies, but the use effectiveness for avoiding pregnancy appears to have improved over the study period.
de Leizaola MA, 1998·J Gynecol Obstet Biol Reprod (Paris)
A Belgian pilot-study conducted in the framework of the prospective European multi-center study (University of Düsseldorf) tried to establish the use-effectiveness (a sine qua non condition for its acceptance in Europe) of natural family planning. 84 participants provided data (sympto-thermal chart and related information) on 1,750 cycles where family planning intention was to avoid a pregnancy. The average age of the women was 32 years. A contraceptive method (mainly oral contraceptives) was employed previously by 61% of them. The sympto-thermal method used by the test group highlights the beginning and the end of the menstrual cycle's fertile period by a double check. As to the start of the fertile period, a calculation on the length of the previous twelve cycles and the first sign of mucus at either the vulva or the cervix. Indicators the third day of high temperature and the fourth evening after either the peak mucus day or the peak cervix day. 75% of the women involved generally use the cervical auto-palpation. No method failure at all has been detected. Two unplanned pregnancies occurred due to user failure. The total Pearl index for the study was 1.4. When examining only those cycles (85% of the reported cycles) where no protected sexual intercourse occurred during the fertile phase, practical efficacy of the method analysed was 1.8 according to Pearl index. Furthermore, taking into account protected and unprotected sexual intercourse occurred during the fertile phase, we observed that sexual abstinence was practised during the "risk" period of 75% of the cycles. The results of this test study demonstrate the practical efficiency of a modern natural family planning method. The high level of cycles during which periodic abstinence was employed testify to the acceptability of the method used.
The purpose of this pilot study was to correlate the three biologic markers of the Ovulon fertility monitor (a long-term predictive peak about 6 days before ovulation, a short-term predictive peak about 1 day before ovulation, and a nadir at the time of ovulation) with the peak in cervical mucus and the luteinizing hormone (LH) surge in the urine. Ten volunteer subjects (mean age 30.2 years) monitored their cervical-vaginal mucus, the surge of LH in the urine with a home assay test, and their vaginal electrical readings (with Ovulon monitors) on a daily basis for one to four menstrual cycles. In 19 of the 21 cycles that indicated a LH surge, there was a strong positive correlation between the LH surge and the peak of cervical-vaginal mucus (r = 0.96, P < or = .01), and between the LH surge and both the Ovulon nadir and Ovulon short-term predictive peak (r = 0.84, P < or = .01), and a modest positive correlation between the long-term Ovulon predictive peak and the LH surge (r = 0.62, P < or = .01). The time of optimal fertility as determined by the peak in cervical mucus, the LH surge, and the Ovulon was similar. The Ovulon has potential as a reusable device to help women determine their fertile period.
Fertility AwarenessInterest and UtilizationFamily Planning PreferencesReproductive Health
In the United States, approximately 4% of women of reproductive age use natural family planning (NFP) to avoid pregnancy. It is unclear whether this low number is related to a lack of available information, women's lack of interest, or other factors. Our study examined women's interest in using NFP either to become pregnant or to avoid it. A questionnaire was mailed to 1500 women, aged 18 to 50, who were randomly selected from driver's license renewal records in Missouri for the year beginning July 1991 and ending June 1992. Of the 747 returned questionnaires, 484 were from women who were still potentially fertile. Of these women, 22.5% indicated that they would be likely or very likely to use NFP in the future to avoid pregnancy, and 37.4% indicated that they would be likely or very likely to use NFP in the future to become pregnant. Only 2.8% were currently using a method of NFP. Past use of any method of NFP (including the outdated calendar rhythm method) to avoid pregnancy was associated with interest in future use of modern methods of NFP to avoid pregnancy. Past use of NFP to become pregnant and the possible desire for future pregnancy were associated with interest in future use of NFP to conceive. Many women who are not currently using NFP indicated that they are interested in doing so in the future, either to avoid pregnancy or to conceive. Interest in future use of NFP is associated with, but not limited to, those who have previously used NFP.
Fertility AwarenessOvulation and Symptothermal MethodsNursing PracticeClinical Application
Trent AJ et al., 1997·J Obstet Gynecol Neonatal Nurs
Two common natural family planning (NFP) methods are the ovulation method based on characteristics of cervical mucus and the symptothermal method based on changes in cervical mucus, basal body temperature, and the cervix. Both methods are effective when used correctly. Nurses should understand the principles of NFP and introduce these methods in discussions of family planning options. Interested clients should be referred to a certified NFP instructor for education and supervision.
Body LiteracyFertility Awareness KnowledgeFertile Window UnderstandingConception Timing Knowledge
Eighty women attending for consultation at a tertiary referral fertility unit over a 3-month period were surveyed for their knowledge of fertility awareness and how they used this information to enhance their chances of conception. It was hypothesized that less than 50% of the subjects had an adequate understanding of when the fertile time occurred in their menstrual cycle. A questionnaire was completed anonymously by each subject and these were scored in 3 categories for fertility awareness by 2 independent Natural Family Planning teachers. Scores ranged from 0 for women who had no concept of fertility awareness, to 6 for women who were highly aware. The results showed that 26% (N = 21) of subjects had a score of 4 or greater which was considered as having an adequate understanding. The hypothesis was accepted, giving reason for concern about the effectiveness of consumer education at all levels of fertility investigation.
Fertility AwarenessProvider Perspectives and BarriersNFP in Family PlanningNFP Service Expansion
Despite the recognized benefits for clients and programs of providing natural family planning (NFP) services, few family planning programs offer NFP and few provide fertility awareness education. Furthermore, many non-governmental organizations (NGOs) that provide only NFP actually reach a very small percentage of the potential NFP users in the areas they serve. This paper discusses the results of interviews with selected family planning providers that were conducted to explore reasons why NFP and fertility awareness education are not offered in their programs, and with NFP providers to get their opinions on how to improve service delivery. The interviews were structured around some of the lessons learned from the successful incorporation of the lactational amenorrhea method (LAM) into several multimethod family planning programs. There is agreement that the need for NFP services* is far from being met and that most clients lack the information and skills they could learn through fertility awareness education. The providers interviewed also acknowledged that offering these services would improve the quality of reproductive health services in general. Presented here are some ideas about why these services are not offered, as well as suggestions for integrating NFP and fertility awareness education into existing family planning programs.
Body LiteracyReproductive Health AwarenessBody KnowledgeCommunication Skills
To protect and advocate for their own reproductive health, people of all ages can greatly benefit from enhanced body/self awareness and strong interpersonal communication skills. Body/self awareness and interpersonal communications, along with gender awareness and the integration of sexuality, are the fundamental components of a new approach to obtaining high quality health called reproductive health awareness.
Fertility AwarenessStudy EvaluationContraceptive EffectivenessNatural Family Planning
To equip the reader with the tools necessary to evaluate studies of natural family planning (NFP) effectiveness found in the literature and to make recommendations for future NFP effectiveness studies.
Current standards to evaluate contraceptive method effectiveness are reviewed. A framework for evaluating reports on NFP is presented. Most NFP studies found in the literature are flawed in design and do not calculate pregnancy rates correctly. The results from the few well-designed studies are presented. Many factors influence NFP effectiveness, and these factors must be considered when evaluating published studies and designing future studies.
Body LiteracyBehavior ChangeSocial MarketingReproductive Health Awareness
Social marketing applies commercial sector ideas to programs to change behavior. It involves a mindset that is customer-focused; a process that starts with customers and continually returns to them for validation; and concepts to make change happen. Customer behavior models guide strategy. One useful model is based on stages of change perceived benefits, perceived costs, the influence of others, and perceived behavioral control.
This paper presents demographic data about use of NFP in Europe and the factors which have been identified as influencing that very low use level. Experience with a new ovulation detection device in clinical trials and observations of its over-the-counter promotions is discussed in the context of what is already known about how to maximize uptake of contraception in main-stream service provision. Some suggestions are offered as to appropriate means of encouraging women who are using artificial methods or no method to understand enough about their natural fertile cycle to consider NFP as an acceptable option.
Fertility AwarenessCalendar-Based MethodsPilot StudiesStandard Days Method
Natural methods of fertility regulation are acceptable in most cultures. Many couples worldwide do not wish to use contraceptives or do not have access to them but wish to limit their family size or lengthen the time between births. Barriers to expanding use of natural family planning (NFP) methods include a lack of providers who can teach NFP and a lack of time to teach and follow couples during the initial months of NFP use. If simple yet effective methods of NFP are available, then NFP could be introduced to a wider audience. Recently, calendar rules have been revised that use a set interval to identify fertile days. These new rules provide better coverage of fertile days and require less abstinence than the rules traditionally used with the calendar method. One of these new rules is being field tested in a pilot study in Brazil. Couples are asked to abstain from day 9-19 (inclusive) of the menstrual cycle, using a beaded necklace (the 'collar') as a mnemonic device. Focus groups with the teacher-monitors and in-depth interviews with female and male users were carried out to evaluate the acceptability of the 'collar' method. A preliminary analysis of these focus groups and interviews from the first site is presented.
Body LiteracyReproductive Health AwarenessProgram DevelopmentCommunity Education
The Georgetown University Institute for Reproductive Health has evolved a multi-dimensional approach to reproductive health education which has grown from their work in natural family planning and fertility awareness. This cohesive approach offers help to community, educational, and health organizations in providing knowledge and skills development in body/self-care, gender awareness, sexuality, and interpersonal communications.
Fertility AwarenessCalendar MethodSexual Behavior During AbstinencePilot Studies
A pilot study was conducted in Ireland to test the effectiveness of the calendar method of contraception. A conservative rule was used, requiring on average 16 days of abstinence per cycle. Among the 19 couples who entered into the study and were followed for up to seven cycles, there were no pregnancies. Since the length of abstinence was relatively long, we collected data to determine how couples expressed love and affection towards each other during those days when the woman was potentially fertile. We also collected data about barrier method use during the fertile time. We found that almost all couples gave each other hugs and kisses to show affection although couples were taught to abstain from vaginal intercourse during the fertile time. About one-third of the couples avoided genital contact, while about half reported using oral sex and/or frottage (body rubbing). Twice as many men reported using masturbation compared to women, although about half of the couples practiced mutual (partner) masturbation. In addition, about one-fifth of the couples used condoms during the fertile time in some cycles. These findings show that a variety of sexual expressions are used by couples when vaginal intercourse is to be avoided. Knowledge about these alternative sexual expressions may be important for couples who wish to engage in sexual activity and to avoid pregnancy.
Fertility AwarenessContinuation RatesSatisfaction and BarriersNFP User Characteristics
This study has determined long-term continuation rates of clients who attended clinics of the New Zealand Association of Natural Family Planning and became autonomous users. It has also identified factors which might influence the continuation of NFP use. A total of 509 female subjects, 452 of them with their male partners, were enrolled in the study at the beginning of clinic teaching. Once autonomous they were sent questionnaires at 6-monthly intervals for a period of 24 months. Time out was allowed for pregnancy. The number of female subjects entering the 2-year follow-up phase of the study was 406 (79.8%). Of these 164 completed 2 years of use with 102 (20% of study entrants) using NFP and 62 (12.2%) using fertility awareness in combination with a barrier method. Subjects for whom NFP was their first family planning method, who were Catholic or who gave religion as their reason for choosing NFP were more likely to continue long-term use. The majority of subjects (> 90%) were highly satisfied with NFP use, with the most common reasons for satisfaction being self-awareness, freedom from drugs, naturalness and effectiveness. The difficulties reported related to abstinence and cycle interpretation.
Body LiteracyProvider Knowledge and TrainingHealthcare Provider AttitudesFamily Planning Services
The hospital-centered trend that has dominated medical culture and the management of health care during this entire century has, in the last few years, undergone a reversal in Italy. Conditions in other countries suggest that similar changes have or will become increasingly common. The family physician today manages many of the functions previously handled by hospitals and specialists. In the field of reproductive health, family physicians are responsible not only for diagnosis and treatment, but also for prevention and education. The present study considers this new context with the objective of investigating the knowledge and behavior of Italian family physicians in the field of women's health, with particular regard to family planning (including natural family planning), through (1) a qualitative study (focus groups) of a small group of family physicians and (2) a questionnaire sent to 500 family physicians throughout Italy. The results of the focus group are summarized in the form of obstacles that the family physician finds in providing family planning services and proposals for change. The results indicate that because of their holistic approach, the family physician is an appropriate provider of family planning services although continued use of specialists' services, changes in logistics of the family physicians' practice, increased gender sensitivity, and additional training and information are necessary. The results of the questionnaire (121 responses, 24.2%) indicate that the Italian family physician currently lacks certain important information about family planning and would require logistical support to provide these services but is interested in acquiring information and is an appropriate family planning provider. An additional challenge for encouraging family practitioners to provide natural methods is that they favor a "medical" approach rather than a "behavioral" one in their treatment preferences for several other conditions.
The purpose of this study was to compare the CUE Ovulation Predictor with the ovulation method in determining the fertile period. Eleven regularly ovulating women measured their salivary and vaginal electrical resistance (ER) with the CUE, observed their cervical-vaginal mucus, and measured their urine for a luteinizing hormone (LH) surge on a daily basis. Data from 21 menstrual cycles showed no statistical difference (T = 0.33, p = 0.63) between the CUE fertile period, which ranged from 5 to 10 days (mean = 6.7 days, SD = 1.6), and the fertile period of the ovulation method, which ranged from 4 to 9 days (mean = 6.5 days, SD = 2.0). The CUE has potential as an adjunctive device in the learning and use of natural family planning methods.
The optimal timing of sexual intercourse in relation to the day of ovulation in order for pregnancy to result is a topic of broad interest. Of obvious relevance to fecundability, on the one hand, a...
The Couple to Couple League (CCL) is pleased that an article and an editorial in the December 1995 issue of the well-respected New England Journal of Medicine confirm that natural family planning (NFP) has value and is scientifically based, a fact the CCL has known for many years. The research covered in the article entitled Timing of Sexual Intercourse in Relation to Ovulation found that the only fertile days were the five days before ovulation and the day of ovulation itself. Most conceptions (76.4%) occurred during the day of and the first and second days before ovulation. CCL's slide showing the extent of the fertile time reflects the data of the report, but also includes the possibility of a second ovulation occurring within 24 hours of the first ovulation. The study found that women conceived in only 37% of cycles in which intercourse took place during the six-day fertile period. This rate is not much different than that claimed by a NFP physician many years ago (about 30%). The study showed the highest conception probability to be when the couple had sexual intercourse every day during the fertile period (37% vs. 33% for every other day). CCL advises couples to abstain until the fertile period then follow one coital frequency period during one cycle (e.g., every day) and the other pattern the next cycle (e.g., every other day). The study refuted claims that the timing of coitus relative to ovulation was not associated to the sex of the baby and that aging sperm do not reduce the viability of the fetus and/or cause birth defects. In fact, aging sperm rarely fertilize the ovum. The only way to positively detect ovulation is seeing the ovum burst out of the ovary. Hormone analyses of blood or urine and observations of cervical mucus and basal body temperature allow an estimate of the day of ovulation. NFP is not based on detecting ovulation but on identifying the limits of the fertile period.
There are couples with unmet family planning needs and couples who do not use any modern method, yet they desire to space or avoid pregnancies. Many of them look for safe and effective options like the natural family planning methods. The Billings Ovulation Method based on single index cervical mucus parameter is one such option. The present multicentre trial conducted in India has shown an encouraging use-effectiveness of the method, indicating method failure as low as 1.5 +/- 0.3 and use-failure 15.9 +/- 0.8 per 100 users at 21 months. The method continuation rates have also been as high as 88.3/100 users at 6 months and 52.0/100 users at 21 months.
Fertility AwarenessTiming of IntercourseConception ProbabilityUrinary Hormone Metabolites
The timing of sexual intercourse in relation to ovulation strongly influences the chance of conception, although the actual number of fertile days in a woman's menstrual cycle is uncertain. The timing of intercourse may also be associated with the sex of the baby. We recruited 221 healthy women who were planning to become pregnant. At the same time the women stopped using birth-control methods, they began collecting daily urine specimens and keeping daily records of whether they had sexual intercourse. We measured estrogen and progesterone metabolites in urine to estimate the day of ovulation. In a total of 625 menstrual cycles for which the dates of ovulation could be estimated, 192 pregnancies were initiated, as indicated by increases in the urinary concentration of human chorionic gonadotropin around the expected time of implantation. Two thirds (n = 129) ended in live births. Conception occurred only when intercourse took place during a six-day period that ended on the estimated day of ovulation. The probability of conception ranged from 0.10 when intercourse occurred five days before ovulation to 0.33 when it occurred on the day of ovulation itself. There was no evident relation between the age of sperm and the viability of the conceptus, although only 6 percent of the pregnancies could be firmly attributed to sperm that were three or more days old. Cycles producing male and female babies had similar patterns of intercourse in relation to ovulation. Among healthy women trying to conceive, nearly all pregnancies can be attributed to intercourse during a six-day period ending on the day of ovulation. For practical purposes, the timing of sexual intercourse in relation to ovulation has no influence on the sex of the baby.
Fertility AwarenessSymptothermal MethodBillings Ovulation MethodNFP vs Contraceptive Methods
The scientific foundations and most notable features of modern natural family planning (NFP) methods are described. NFP techniques require observation of the signs and symptoms occurring during the fertile and infertile phases of the menstrual cycle. Abstinence during the fertile period is implied when NFP is used to avoid pregnancy. Modern NFP methods are associated with success rates similar to those of oral contraceptives, the IUD, and condoms. NFP methods are based on such phenomena as the limited survival time of the ovum and sperm, the occurrence of ovulation only once per cycle, the ability to diagnose ovulation using simple means, and the ability of human beings to delay sexual satisfaction. Among the advantages of NFP methods are low cost, brevity of the required training time, increased knowledge of the body and capacity for self control, shared responsibility by both partners, and moral and religious acceptability. The Billings and symptothermal methods have shown average use-effectiveness rates ranging from 71.5 to 89.5% and from 83.4 to 97.8%, respectively. All studies of symptothermal methods conducted since 1985 have shown Pearl indexes under 5. The symptothermal method is based on observation of the duration of previous cycles, cervical mucus, basal body temperature, and optionally on palpation of the cervix and other symptoms such as breast swelling, acne, intermenstrual bleeding, and mood changes. Use of the symptothermal method requires special graph paper for recording the temperature and other symptoms. The beginning of the fertile phase is recognized by subtracting 19 from the shortest cycle in the past year, or by the appearance of cervical changes or changes in the mucus.
Fertility AwarenessNFP Knowledge and AttitudesProvider Promotion and BarriersHealthcare Provider Surveys
Perinatal health professionals are in key positions to either promote or dissuade the use of Natural Family Planning (NFP). The purpose of this article is to describe a survey conducted with perinatal physicians and nurses on their knowledge and professional use of NFP. Four hundred and fifty physicians and nurses (150 MDs and 300 RNs) were sent a questionnaire on the use of and knowledge of NFP. One hundred sixty-six (or 37%) returned the completed questionnaires. Fifty-two percent of the nurses who returned the questionnaires and 48% of the physicians indicated they were taught about NFP in basic (generic) medical or nursing school. The average lecture time spent on the subject in either nursing or medical school was less than one hour. The majority learned about NFP through self-education or on-the-job training. Only four (1 RN and 3 MDs) are certified to teach NFP. Fifty-three percent of the nurses and 44% of physicians would not advise the use of NFP to avoid pregnancy. The most frequent reasons given for not promoting the use of NFP to either avoid or achieve pregnancy were that it is not effective, not natural, too difficult to learn, better methods are available, and it only works for highly motivated educated women.
Fertility AwarenessOvulation and Symptothermal MethodsPerfect Use vs Typical UseNatural Contraception
A better understanding of reproductive anatomy and physiology has led to newer methods of natural family planning, including the ovulation method and the symptothermal method. Studies have shown that 1 percent of couples who consistently and correctly use either of these methods conceives during one year of use. However, in the absence of standardized interpretation of study results, use-effectiveness data of these methods vary widely. The lactational amenorrhea method may be used in selected patients during the first six months postpartum, and its effectiveness in avoiding pregnancy is reported to be as high as 98 percent. Advocates of natural family planning promote these methods as inexpensive and safe ways to determine periods of peak fertility and point to the potential benefit of increased communication in a relationship.
Fertility AwarenessSexual Activity PatternsEffectiveness and ComplianceNFP Behavioral Analysis
For 10 years, a prospective study has been taking place in Germany to examine the use of natural family planning (NFP). As natural methods are behavioral methods, use-effectiveness, acceptability and continuation rates are very much influenced by patterns of sexual behavior. Therefore we performed an analysis of the sexual behavior of NFP users. Out of the data base of 1211 clients and 12,591 cycles we could identify a group of 300 women, all NFP beginners, with 5900 contraceptive cycles, who contributed at least 12 cycles with reliable recording of their sexual activity. Different groups were analyzed with methods of analysis of variance and regression models to find out significant differences in their sexual behavior with respect to sociodemographic structure and time of use. Nearly half of all the women systematically combine the fertility awareness part of NFP with other family planning methods. They use barriers in more than 60% of their cycles. The other half never or only in about 7% of their cycles use additional barrier methods. The latter show a clear decrease in barrier use in the course of time, whereas the frequent barrier users constantly combine the advantages of two family planning methods. Regarding the frequency of intercourse they are the sexually more active ones and show distinct sociodemographic characteristics. We could confirm the existence of three groups of NFP users, which differ significantly in their use of NFP as a family planning method. Despite these differences the low pregnancy rates indicate the conscious and risk-related sexual behavior of the group members.
During lactational amenorrhea a special type of cervical mucus, similar to that found during the luteal phase, is produced. This mucus, however, is able to support sperm migration. In the study described, the ability of spermatozoa to bind to the human zona pellucida (hZP) after migration through periovulatory and post-partum mucus was studied. Mucus was obtained from exclusively breastfeeding women in amenorrhea at 30, 60, 120 and 180 days post-partum. Periovulatory mucus samples from normally cycling women were used as a control. Flat capillary tubes were filled with BWW culture medium at the top and cervical mucus at the bottom. The tubes were immersed in a semen reservoir and the spermatozoa allowed to migrate through the mucus for 3 h into the culture media. Then the spermatozoa were coincubated with 3-4 hZP for 30 min and the number of bound spermatozoa per zona was counted. Periovulatory cervical mucus had an average Insler score of 14 +/- 0.5 as compared to 4.6 +/- 0.4 for post-partum mucus. Spermatozoa recovered from periovulatory mucus were always able to bind to the hZP in only 68 +/- 7% of the cases. Moreover, spermatozoa recovered from post-partum mucus bound to the ZP in lower numbers than did spermatozoa recovered fro periovulatory mucus (p < 0.03). These results suggest a greater ability of sperm-hZP binding after migration through periovulatory mucus and they also indicate that sperm binding to the ZP is possible even after sperm migration through a low quality mucus.
NaProTECHNOLOGYDevelopment and HistoryBillings Ovulation MethodNatural Family Planning
The following is an address presented to a summit meeting on natural family planning sponsored by the Pontifical Councilfor the Family in December, 1992
I am honored and privileged to have this opportunity to be with all of you at this summit meeting on natural family planning. I wish to thank Alfonso Cardinal Lopez Trujillo for his invitation and all ofthe members ofthe Pontifical Council for their generosity and hospitality.
I have been asked to discuss with you what has become known as the Creighton Model Natural Family Planning System. This system obtained its name from my personal association, in its early days of development, with Creighton University School of Medicine in Omaha, Nebraska. This discussion will be, by its very nature, a summary of work that has been done and work that is currently ongoing.
The Creighton Model is referred to as a "model" as opposed to a "method" because it is an integrated education, research and service oriented system which meets the demands of the allied health and medical professions in the field of natural family planning. This system was specifically built to accomplish accountability and competency through a strong professional infra-structure. At the same time, it has been built within the context of a Catholic ethical and moral service delivery framework. It uses a standardized modification of the Billings' Ovulation Method in accomplishing these goals.
I personally became involved in natural family planning with a research project I did as a senior medical student in 1968. As I investigated the salivary albumin concentrations in women during the course of their menstrual cycles, I was looking for a reported decrease in albumin around the time of ovulation. Unfortunately, a project which I had no doubt would solve the problems related to natural family planning (sic), proved to be not a very good idea. . .
Fertility AwarenessInterest and AttitudesAdoption and BarriersPatient Preferences
Although modern methods of natural family planning (NFP) are effective both to avoid and to achieve pregnancy, relatively few women use these methods. It is not known whether this is due primarily to lack of interest or to other factors. We therefore explored the level of interest in NFP among female family practice patients. We mailed information about NFP to 400 female patients between ages 21 and 42 and conducted follow-up interviews by telephone. We excluded 162 women for whom we could not obtain accurate addresses or phone numbers, 68 women we could not reach by telephone, 67 women who were not currently at risk of pregnancy, and 15 women for other reasons. Twenty-eight women refused to participate in the study. Sixty women completed telephone interviews. Forty-three percent of respondents (n = 60) were interested in learning more about NFP, 24% said they were likely to use NFP to avoid pregnancy, and 32% were likely to use NFP to achieve pregnancy. Younger women and women who were Christian but not Catholic and not of a major Protestant denomination were more interested in NFP. Some female family practice patients are interested in learning and using NFP.
Fertility AwarenessPsychosocial OutcomesRelationship QualitySpiritual and Psychological Impact
This paper describes the evaluation of a new method of natural family planning (NFP) in Liberia. The Modified Mucus Method (MMM) was developed to address the need for a simple method of charting for poor and illiterate women. The acceptance, use, and cost-effectiveness of the MMM were compared with standard NFP methods, the sympto-thermal and ovulation method (ST/OM), used in the same population. The personal discontinuation rate of MMM users was 27.3 per 100 women per year compared with 3.2 among ST/OM users. Unplanned pregnancy rates were low for both MMM and ST/OM, 6.6 and 1.5 respectively. The cost per couple year protection (CYP) for MMM was $55.80 and for ST/OM $56.10. There were differences in characteristics between MMM and ST/OM clients. The MMM clients were more likely to have attended school and to have used a family planning method previously, and were less likely to be housewives. We conclude that the MMM in Liberia was provided to an inappropriate sample of women, educated and middle-class rather than poor and illiterate. The MMM users were dissatisfied and discontinued at the rate of 44 per 100 women entering per year. This is an unfair evaluation of the MMM because of the unsuitable study population. It is our opinion that the MMM needs more study to become part of the inventory of birth spacing methods.
Fehring RJ et al., 1994·J Obstet Gynecol Neonatal Nurs
To determine the use effectiveness of the Creighton model ovulation method in avoiding and achieving pregnancy. Prospective, descriptive. A natural family planning clinic at a university nursing center. Records and charts from 242 couples who were taught the Creighton model. The sample represented 1,793 months of use of the model. Creighton model demographic forms and logbook. At 12 months of use, the Creighton model was 98.8% method effective and 98.0% use effective in avoiding pregnancy. It was 24.4% use effective in achieving pregnancy. The continuation rate for the sample at 12 months of use was 78.0%. The Creighton model is an effective method of family planning when used to avoid or achieve pregnancy. However, its effectiveness depends on its being taught by qualified teachers. The effectiveness rate of the Creighton model is based on the assumption that if couples knowingly use the female partner's days of fertility for genital intercourse, they are using the method to achieve pregnancy.
Fertility AwarenessOvulation MethodCervical Mucus and TemperatureReturn of Fertility Detection
Natural family planning (NFP) methods can be effective if taught well and practised by well-motivated couples. Midwives should be able to give couples an understanding of the basic principles of the methods. The observable signs of the fertile cycle are changes in basal body temperature, in the consistency of cervical mucus and in the texture and position of the cervix. Practised properly the ovulation method can have a failure rate of as little as 2.2 pregnancies per 100 woman-years. The ovulation method is a suitable method for mothers who have breastfed to detect the onset of ovulation.
An introduction to and some new anatomical and physiological aspects of the cervix and vagina are presented and also an explanation of the biosynthesis and molecular structure of mucus.
Since 1989 an international multicenter prospective study to evaluate the effectiveness and acceptability of natural family planning (NFP) methods in Europe has been conducted by the NFP Research Center at the University of Düsseldorf in collaboration with the European Zone of the International Federation for Family Life Promotion (IFFLP). Fourteen NFP-organizations from nine European countries participate in the study. Cycle data from women in the fertile age group are transferred to a special standard computer sheet by the respective organizations and forwarded at three-monthly intervals to the study center for analyses. To date, 10,045 cycles from 900 women aged between 19 and 54 years have been analyzed. This paper presents the pregnancy rate for the women aged between 19 and 45 years of age, who contributed 9284 cycles. In the analyses the cycles were subdivided into two categories consequent to sexual practices group I (NFP only--4277 cycles) use only NFP to avoid a pregnancy; group II (FA/mix--5007 cycles) where barrier methods or coitus interruptus during the fertile phase, at least in some cycles, were used to avoid a pregnancy. The women used different clinical indicators such as basal body temperature (BBT), cervical mucus, calculations, cyclical cervical changes or combinations of these to determine the beginning and the end of the fertile phase necessitating a further division into four subgroups, A, B, C, D, and different efficiency rates for each of these groups. In group A (symptothermal method, double check) 15 unintended pregnancies (UIP) occurred in 7404 cycles, giving a pregnancy rate of 2.4 Pearl Index (PI); in group B (muco-thermal method) there were 12 UIP in 1352 cycles with a pregnancy rate of 10.6 (PI); in group C (mucus to detect the beginning and mucus and BBT to determine the end of the fertile phase) there was one UIP in 434 cycles, and in group D (mucus method only) there was one IUP in 70 cycles. The numbers in group C and D are too small to calculate a pregnancy rate (PI). No pregnancy was observed in women over 40 years of age. Our conclusion from these preliminary results is that in the continent of Europe, the symptothermal method when used with periodic abstinence (NFP only = group I) and fertility awareness with the use of barriers during the fertile phase (FA/mix = group II) are effective methods of family planning.(ABSTRACT TRUNCATED AT 400 WORDS)
good of all, and above all, for the protection of the weak."2I submit that, no matter how appealing a marketplace model may seem for the NHS, it is a business model.As such the destruction of either purchaser or provider is eventually certain, with the barbarisation of the survivor.It is not too late for consortiums of purchasers and consortiums of providers to join forces and become one NHS again.
Body LiteracyInstitutional ProgramsCatholic HealthcareNFP Integration
A recent survey conducted by the American Academy of Natural Family Planning (AANFP) found that over 55% of Catholic hospitals surveyed either provide or would like to provide some form of Natural Family Planning (NFP) services. In addition, over 60% of the respondents felt that NFP should be part of the mission of a Catholic hospital.
In spite of constant efforts by health and social workers, existing family planning measures are not used by a vast majority of eligible couples. This is because of the fear that the method may affect their health and happiness. Billings' ovulation method is based on the scientific observation that by noting the changes in cervical mucus, which is clear, slippery and copious in periovulatory period, it is possible to prevent pregnancy by avoiding intercourse during this period. As this method does not require the use of drugs or devices it was decided to promote this method in the urban areas and slums of Patna, Bihar where couples were not using other methods. This is not a comparative study of the cost-effectiveness of Billings' ovulation method versus other contraceptive measures at all. An analysis of 501 cases (267 in urban and 234 in slums) over a period of 2 1/2 years has been presented and it is gratifying to note that the couples from all religions and strata of the society (nearly 47% were slum dwellers) agreed to continue this method.
Studies to evaluate use-effectiveness and cost-effectiveness of natural family planning (NFP) were conducted in Liberia and Zambia. The Liberian programme provided uni-purpose NFP services to 1055 clients mainly in rural areas; the Zambian programme provided NFP services integrated with MCH to 2709 clients predominantly in urban areas. The one-year life table continuation and unplanned pregnancy rates were 78.9 and 4.3 per 100 woman-years in Liberia, compared to 71.2 and 8.9 in Zambia. However, high rates of loss to follow-up mandate caution in interpretation of these results, especially in Zambia. More women progressed to autonomous NFP use in Liberia (58%) than in Zambia (35.3%). However, programme costs per couple-year protection were lower in Zambia (US$25.7) than in Liberia (US$47.1). Costs per couple-year protection were higher during learning than autonomy, and declined over time. These studies suggest that NFP programmes can achieve acceptable useand cost-effectiveness in Africa.
Delangue AF, 1993·Soins Gynecol Obstet Pueric Pediatr
The Billings method, or cervical mucus method, is a natural family planning method developed during the 1970s by the Australian physicians John and Evelyn Billings. The method requires periodic abstinence during the periods recognized as fertile according to the characteristics of the mucus. The method can be used to avoid pregnancy or to favor it through identification of the day of maximum fecundity. The method does not alter the natural rhythms of the body or entail unpleasant side effects. At the beginning of the menstrual cycle, the cervix is closed by a mucus plug and the sperm survive less than two hours in the acidic environment of the vagina. Several days before ovulation, the cervix begins to secrete mucus that will protect the sperm from the acidity of the vagina and permit their passage to the uterus. Thus protected, the sperm can survive up to four days. Mucus at this stage has an elastic quality. After ovulation, the mucus thickens and becomes increasingly impenetrable to sperm. It feels sticky and gelatinous. The Billings method requires observation of the sensation of wetness or dryness and the characteristics of the mucus. Each evening the woman should note that day's observations on a chart. The "peak day" is the last day of elastic mucus that gives a sensation of wetness. The peak day is the most visible sign of ovulation and can be recognized only on the next day. The three days following the peak day are considered fertile, because ovulation can occur up to 48 hours after the peak and the ovum can survive up to 24 hours. If the Billings method is used to avoid pregnancy, intercourse should be avoided during menstruation as the appearance of mucus may be masked in a short cycle. Intercourse is permissible in the evening of every second day until the appearance of the mucus.
Fertility AwarenessDiagnostic MethodsFertility BiomarkersNatural Family Planning Research
Cervical mucus is produced throughout the menstrual cycle. Sperm migration, however, is possible only during the periovulatory period of the cycle. Cervical mucus is also produced during the amenorrhoeic post-partum period. Post-partum mucus is very similar to luteal phase mucus except that it can allow sperm migration. In this study, mucus samples obtained from all these periods were classified according to their capacity to allow sperm migration. The biochemical characteristics of mucus samples that did (peri-ovulatory and 40% of post-partum samples) and did not (luteal and 60% of post-partum samples) allow sperm migration were then compared. Mucus samples with positive sperm migration showed the highest percentage of water and lowest protein and glycoprotein concentration (per ml of mucus). In addition, post-partum mucus samples with positive sperm migration showed lower concentrations of proteins and glycoproteins than post-partum mucus samples that did not allow sperm migration. However, the amount of glycoproteins per mg of protein was similar between post-partum samples that were positive and negative for sperm migration. These data suggest that the carbohydrate composition of the glycoproteins is playing a key role in the ability of cervical mucus to accept spermatozoa.
NaProTECHNOLOGYPregnancy AchievementCreighton Model SystemFertility-Focused Intercourse
Fifty consecutive clients achieved pregnancy using a standardization modification of the Billings ovulation method (the Creighton Model Natural Family Planning System). Of 50 clients followed, 38 (76%) achieved pregnancy in the first cycle of fertility-focused intercourse, 45 of 50 (90%) achieved pregnancy by the third cycle and 49 of 50 achieved pregnancy by the sixth cycle (98%).
Natural family planning (NFP) is based on the knowledge *largely nonexistent) of a women as to whether she is in her fertile period or not. In contrast to the calendar method, the Billings method consists of observing bodily functions, whereby women learn about the fertile and infertile period during the menstrual cycle. This method is very safe as long as the woman has been instructed thoroughly. The Pearl index (the number of pregnancies/100 woman years) can be 1. In a Swedish province, 7/1000 population used this method and had an abortion rate of .5/1000, a fact contradicting the allegation of mass abortion as a result of the method. Only well-trained NFP instructors can teach women, and at the University of Umea such training has been available for some years. The biological basis of the Billings method rests on the fact that every release of an egg is preceded by a ripening process of a follicle in the ovary. This follicle secretes increasing amounts of estrogen which stimulates the cervix to produce secretions for the sperm. Right before ovulation, the follicle reduces estrogen production and noradrenaline takes over, stimulating the peak-day secretion (P-secretion) for further selection of sperm. Ovulation usually occurs on the peak day, which is the day of maximum fertility and the last day of mucous symptoms. For 3 days after peak day until menstruation, the risk of becoming pregnant diminishes successively until it is as low as after sterilization. The instructor is trained to recognize and overcome certain factors that make it more difficult to identify the mucous symptoms, such as the previous use of oral contraceptives, certain illnesses, drugs, and life styles. NFP can also be used for attaining pregnancy by identifying the peak day; women with premenstrual syndrome can calculate when their symptoms start, and sportswomen can predict the time of their menstruation. NFP is fascinating when it is compared to other methods because of its human dimension, and there is still a great deal to be learned about it.
Davis MS, 1992·NAACOGS Clin Issu Perinat Womens Health Nurs
Natural family planning includes the calendar (rhythm), basal body temperature, ovulation (mucus), and sympto-thermal methods. Reliability of such methods often is underestimated, but effectiveness of various methods has been reported. Correct understanding and use of proper techniques, primarily abstinence during fertile periods, is imperative for effectiveness. New methods being studied may heighten awareness of fertile times and shorten required periods of abstinence or use of back-up methods.
Fertility AwarenessEfficacy EvaluationPearl Index AnalysisFamily Planning Regulation
5 major criteria are used to evaluate efficacy, both theoretical and practical; acceptability as measured by continuation of use; safety; reversibility; and cost, including the cost of treatment, follow-up, and screening for contraindications. Traditional family planning methods are mostly based on periodic abstinence during the presumed fertile period. The calendar, temperature, Billings or cervical mucus, and symptothermal methods are based on observation of different symptoms of ovulation and fertility. Their advantages are that they do not require intervention by health personnel, their costs of use are nil, and they are morally acceptable to some couples. Their efficacy is lower than that of other methods and they should be viewed as methods to space rather than limit births. The withdrawal method, also less effective, requires active cooperation by the male partner. Among mechanical methods, the use of condoms has increased recently because of the protection they offer against HIV infection and other sexually transmitted diseases. Their efficacy depends on correct use, regular use, and the quality of the condom. The Pearl index varies from 93099 per 100 woman-years. The diaphragm must be individually measured and should be used with spermicides. The Pearl index ranges from 85095 per 100 woman-years. Spermicides, generally either nonoxynol-9 or benzalkonium chloride, are surfactants that have a Pearl index of 83-97 per 100 woman-years. They are available as creams, jellies, foams, suppositories, tablets, or impregnated sponges. Most failures appear due to errors of utilization. The mechanism of action of the IUD is imperfectly understood, but it is known to prevent nidation of the fertilized egg. Copper devised have higher rates of efficacy and tolerance. Pearl indices range from 95-99.5. Contraindications include genital infection, uterine anomalies, valvular cardiopathy, and coagulation problems. The IUD is relatively contraindicated if there is history of ectopic pregnancy or upper genital tract infections. The combined oral contraceptive is the most widely utilized method in France. The Pearl index is nearly 100 in the absence of forgetting, vomiting, or drug interactions. The contraindications are history of thrombosis, prolonged bedrest, hypertension, hyperlipidemia, hepatic disorders, hormonodependent cancers, or smoking after age 35. Progestin-only methods are available in 3 low-dose pills which must be taken at the same time each day, higher-dosed progestins taken for 20 days each month, and injectable progestins providing contraception for 8-12 weeks. Postcoital contraception using OCs or IUDs is possible but not well known among women or physicians. The Neuwirth law authorizing use of contraception in France was passed in 1967. Amendments in 1974 improved access and provided for reimbursement for some methods, but some newer forms are not reimbursed.
Fertility AwarenessElectronic Fertility MonitorsOvulation Detection DevicesTechnological Aids
In recent years, several new devices have been developed to help women achieve or avoid pregnancy. These devices include computerized basal body temperature thermometers, electronic fertility monitors, and chemical and hormonal ovulation detection kits. This article describes these new fertility devices and discusses their effectiveness and impact on helping women understand and control their fertility.
In this study we have evaluated the score, sperm migration and ultrastructural characteristics of cervical mucus present in amenorrhoeic women under exclusive breastfeeding at 30, 60, 90, 120, 150 and 180 days post-partum. Periovulatory mucus samples from seven normally cycling women were used as a control. The average scores of post-partum and periovulatory mucus were 4.6 +/- 0.4 and 14.1 +/- 0.5 respectively. Twenty-one (39%) of the 54 post-partum cervical mucus samples and all (100%) periovulatory mucus samples allowed sperm migration. Positive sperm migration into post-partum mucus was observed at all time intervals studied. The only parameter that correlated with sperm migration into post-partum mucus was ferning formation. Sperm migration was obtained in all post-partum mucus samples with a score greater than 8, but samples with scores between 2 and 7 also showed sperm penetration. Scanning electron microscopic studies showed the characteristic spongy appearance of periovulatory mucus. Post-partum mucus was formed by a dense mesh (rocky appearance), when samples were generally unable to sustain sperm migration, but samples where sperm migration occurred showed small areas of spongy mucus mixed with areas in which a dense mesh and high cellularity was observed.
NaProTECHNOLOGYMedical DiagnosticsCreighton Model SystemClinical Utility
Fertility and the mechanism of ovulation is complex. The processes of fertilization and ovulation are described in this report. Information includes a description of the natural indicators of fertility and infertility, the cervical mucus pattern, and the Guidelines for the Billings Ovulation Method. The ovarian monitor which provides for the measurement of ovarian hormones (estrone glucuronide (EIG) and pregnanediol glucuronide (PdG) in a timed specimen of urine is also described. The cervical mucus pattern method measures ovarian hormones and fertility. No more than 2% of women who have been taught the Ovulation Method and performed the charting would need to use the Ovarian Monitor. It is commonly used to assure that the women's observations and interpretations are correct when there is a strong desire to either achieve or postpone pregnancy. For research, the monitor is useful in accurately measuring the timing of ovulation within the phase of potential fertility during the cycle and the changing probabilities of conception on days within the fertile period. The limits of the fertilizing life span of sperm can be measured as well as the factors which influence this life span. The day of maximum fertility, the correlation of the mucus pattern with fertility and time of ovulation, and assessment of conception cycles are measurable. Diagnostic information can be gleaned which will help to explain bleeding patterns, particularly around menopause, where fluctuating ovarian hormonal levels influence unexplained bleeding patterns. The Monitor can be useful as a test for pregnancy in measurement of high PdG and E1G levels. Four phases are identified for interpreting 1) the E1G and PdG levels are declining during the beginning of menstruation to reach a constant level (20-60 nmol/24 hours and .9 - 3.3 mcmol/24 hours); 2) rising E1G values and low PdG values and changing mucus pattern of the preovulatory cycle; 3) the ovulatory phase of peak E1G values (150-450 nmol/24 hours) followed by a distinct fall and the beginning of a rise in PdG values and the Peak of the mucus pattern; and 4) the luteal phase of rising PdG (9-36 mcmol/24 hours), and rising E1G values (100-400 nmol/24 hours) to maximum, and then falling before menstruation.
Canalization of cervical mucus from 31 patients at the obstetric/gynecologic clinic at the Universita Cattolica del S. Cuore in Rome, Italy has studied to determine the biochemical basis of canalization and its dependence on estrogen, to study the action on the canalization of hormones used to induce ovulation, and to correlate fern pattern and canalization. Cervical mucus was collected daily and applied to a glass slide, covered with an object cover, and allowed to dry. The typical arrangement of the dendritic crystals and the presence of channels among them were confirmed. Depending on the phase of the ovulatory cycle, the crystals differed in direction and in number. The number of channels consistently increased as estradiol levels increased during the proliferative phase. This happened in both natural and induced ovulatory cycles. The cervical mucus of patients with primary amenorrhea canalized when treated with estrogens. The channels ran parallel to each other. Yet, during the secretory phase, the number of channels fell rapidly and the channels were lined up in a crisscross fashion. This suggested that sperm penetration is dependent on the orientation of mucus crystals. Indeed in vitro studies showed that spermatozoa enter the periovulatory mucus in tightly packed files as if the mucus allowed only passage in this linear formation. The biophysical characteristics of canalization paralleled those of ferning. Moreover, like ferning, the presence of essential salts and proteins induced canalization. It is concluded that canalization can be used to accurately measure estradiol levels and thus to detect ovulation.
The notion of an oscillator or signal generator in the central nervous system that controls the rhythmic release of GnRH and, thereby, the pulsatile secretion of the gonadotropic hormones, originated in the finding of strikingly abrupt and rhythmic fluctuations in the concentration of LH in the plasma of ovariectomized monkeys. These oscillations had a period of about one hour when blood samples were obtained at 10 to 20 minute intervals.I
These surprising observations were presaged by reports of seemingly random, major fluctuations in plasma gonadotropin concentrations in gonadectomized monkeys" and rats as well as in women.' In these earlier studies, the sampling intervals employed were never less than one hour and unable, therefore, to reveal the orderly, rhythmic events that occur with frequencies of one event per hour or more.
In the original study describing pulsatile LH secretion in ovariectomized monkeys the possibility was considered that the circhoral discharges of LH may be initiated by autoregulatory mechanisms involving long or short feedback loops, but the more likely view that these discharges were due to intermittent signals from the central nervous system unrelated to circulating LH levels that resulted in putative increments in GnRH release was favored. Nevertheless, the possible role of autoregulatory mechanisms in the control of pulsatile LH secretion was repeatedly considered,6 but finally laid to rest in the relatively recent past.7Conversely, the view that each pulse of LH released from the pituitary gland is the consequence of a bolus of GnRH secreted into the pituitary portal system has been unequivocally upheld by the demonstration of synchronous increments of GnRH assessed in the pituitary portal circulation and of LH measured in samples of peripheral blood obtained simultaneously.s, 9 In any case, the phenomenon of pulsatile gonadotropic hormone secretion was rapidly extended to most vertebrate species studied in this regard, including our own, and forms the basis of an increasingly voluminous, rapidly expanding literature.
AndrologyCervical Mucus InteractionAbnormal Sperm FiltrationBiological Function
It is well known that cervical mucus restricts penetration of morphologically abnormal human sperm, both in vitro and in vivo. However, the mechanisms of such restriction are not well understood. Using videomicrography to simultaneously analyze the motions and morphology of individual human sperm, we analyzed differential penetration of normal and abnormal sperm into fresh human cervical mucus. Abnormal sperm swam slower in mucus than the normal sperm, but their flagellar beat parameters were not commensurately different. Multivariate statistical analysis of the relationship between individual sperm velocity and flagellar beat parameters indicated that the heads of the abnormal sperm experienced greater resistance from the mucus than did normal heads. Differential mucus resistance, more than altered motile vigor, appears to be responsible for the restriction of abnormal sperm during migration through mucus.
Menstrual CycleLength Determination MethodsQuantitative AnalysisBBT Validation Against LH Peak
Basal temperature data are known to provide unreliable assessments of luteal phase length when they are evaluated by qualitative, visual-pattern methods. This study of 24 cycles in 24 women compared the serum LH peak day with the luteal phase onset day determined by three quantitative a) a new computerized least mean square method developed by the authors; b) the mean temperature method reported by Vollman; and c) a computerized version of the World Health Organization cumulative sum method of Royston. The luteal phase onset day determined by the three quantitative basal temperature methods, (a, b, and c) correlated well with the midcycle LH peak (r = 0.879, 0.891, and 0.791, respectively, all p less than 0.001). The cumulative sum method, however, was only able to analyze 19/24 cycles. The mean delay between the LH peak day and the luteal phase onset day determined by thermal shift was 2.4 +/- 1.5, 2.7 +/- 1.4, and 4.1 +/- 2.0 d (mean +/- SD), respectively. The mean temperature method, but not the other two methods, showed an increasing delay between the LH peak day and the thermal shift day with longer follicular phase lengths. Rectal and oral temperature data from the same cycle give identical luteal onset days when analyzed by the least mean square and mean temperature methods, but discrepant days by the cumulative sum analysis. The least mean square technique is a reliable and precise method for population documentation of luteal phase lengths.
Fertility AwarenessOvulation Prediction AccuracyLH Surge vs Cervical MucusComparative Validation
Time of ovulation as detected by a self-test of luteinizing hormone (LH) in the urine was compared with time of ovulation as detected by self-observation of cervical mucus. Twenty regularly cycling women monitored their cervical mucus and urine LH for two complete menstrual cycles. Of the cycles that had an LH surge, 100% were on the peak day of cervical mucus or within three days before the peak day. Self-observation of cervical mucus, therefore, can be an accurate method of determining optimal fertility.
In a group of 55 unmarried women, mean age 25 years, attending a family planning clinic and having minor gynecological complaints, the correlation between Chlamydia trachomatis (CT) antigen, CT antibodies, vaginal colonization by Candida or bacteria and the method of contraception was investigated. The correlation between CT antigen and CT antibodies (IgG) was significant in oral contraceptive users (p = 0.003), as was the correlation with vaginal colonization by Candida and potential pathologic bacteria. In the group using the natural family planning method, a statistically significant correlation was found between CT antigen, IgG (p = 0.002), IgA (p = 0.02) antibodies, and vaginal candidiasis (p = 0.002), but not with bacterial colonization (p = 0.90). The discrepancy between CT antigen and antibodies is discussed. Differences in the prevalence of Chlamydia trachomatis infection were found among groups using different birth control methods, indicating an association between Chlamydia infection and the contraceptive method used.
Since physicians strongly influence both national family planning policy and individuals' contraceptive choice, a survey was conducted to learn about the perspectives of Sri Lankan physicians (n-100) regarding periodic abstinence methods of family planning (PA). Female doctors (28% of the sample) were twice as likely to have ever provided PA advice to their clients as their male counterparts. Providers of PA were more likely to have ever personally used this form of contraception than PA non-providers. Regardless of PA provider status, all physicians most frequently recommended pills, injectables and IUDs to their clients. They had very good knowledge of the temperature method. The scientific foundation of this method is studied in medical school, suggesting that if the other modern methods (Billings and sympto-thermal) were incorporated into medical school curricula, physicians might be more willing to discuss, refer or provide other modern, scientific forms of PA to their clients.
Fertility AwarenessNatural Family PlanningHilgers NFP MethodsHuman Ecology
Women can accurately predict the day of ovulation by examining vaginal mucus using the Billings Ovulation Method (BOM). they then can choose to either have sexual intercourse if they wish to conceive or to refrain if they do not want to become pregnant by being able to identify the peak day of fertility and the 3 following days of diminishing fertility. A preovulatory phase of the ovulatory cycle follows menstruation which generally includes a sensation of dryness around the genital area but sometimes no dry days occur. At this point progesterone activates the secretion of a thick sticky mucus into the cervical canal which sperms cannot penetrate. This mucus also serves to guard against infection in the reproductive tract and abdominal cavity. When circulating estrogen increases due to follicular development a fluid clear and stringy mucus replaces the thick mucus. this mucus is like a raw egg white. Under the microscope it has a distinctive fern pattern. Sexual intercourse during this time period may result in pregnancy because this mucus sustains sperm cells in cervical crypts for 48-72 hours. Not all women notice the changes in the mucus however but they can sense the vulva as soft swollen and moist. The final day of this sensation identifies the peak day (day 1) in which ovulation customarily occurs. Even though fertility decreases in the next 3 days conception may occur in days 1-3. Infertility sets in on day 4 and last on average 2 weeks. any mucus now seems sticky and opaque. WHO field trials in El Salvador and 4 other countries confirmed that BOM is >99% effective when couples adhere to the guidelines. Research demonstrated that illiterate couples from low socioeconomic status understand it and apply it successfully.
Five programs of instruction in the ovulation method (OM) in diverse geographic and cultural settings are described, and characteristics of approximately 200 consecutive OM acceptors in each program are examined. the religious background and family size of acceptors are variable, as is the level of previous contraceptive use. Acceptors are drawn from a wide range of socioeconomic and religious backgrounds; however, family planning intention was similarly distributed in all five countries. In sum, the ovulation method is accepted by persons from a variety of backgrounds within and between cultural setting.
Fertility AwarenessPhysician Knowledge and AttitudesHealthcare Provider PerspectivesFamily Planning Counseling
A study of the knowledge, perceptions, and behavioral intentions of physicians regarding periodic abstinence (PA) methods was undertaken in Mauritius, Peru, the Philippines, and Sri Lanka. Most respondents considered PA to be useful, although even the PA providers prescribed mainly non-PA methods. Detailed knowledge of PA methods was not evident, but most physicians were willing to initiate general discussion about PA with patients. Physicians favored methods perceived as "scientific" and "modern," which primarily prevent pregnancy and secondarily avoid other health risks. When carefully presented as "scientific" and "modern," methods presented to medical audiences may find acceptance and be more likely to result in referral.
Ten years' experience of artificial insemination with cryopreserved donor semen for 1023 courses in 783 women resulting in 572 pregnancies is reported. A simple approach with multiple inseminations timed on the basis of cycle length, temperature charts, mucus symptoms and signs was used. The life table pregnancy rate was 61% after 12 cycles of treatment and 75% after 24 cycles. Women had a significantly higher rate of pregnancy in second and subsequent courses of treatment, and the pregnancy rate for treatment beyond 12 cycles was significantly less successful. Women over 35 years of age were significantly less successful.
A 12-month evaluation of the Ovulation Method of Natural Family Planning programme in Bangladesh is presented. Four hundred and forty-eight women entered the programme, 232 for spacing, 184 for limiting, and 32 to achieve pregnancy. Of the participating couples, 79% lived in rural areas and 20.3% were illiterate. The 416 who learned the ovulation method for avoiding pregnancy completed 2,358 months of use, with 14 unplanned pregnancies during the study period, which represents a pregnancy rate of 7.2 according to the Pearl Index. The discontinuation rate in the 12-month period was 2.4%.
Cervical mucus observation may be difficult for women who experience continuous mucus throughout their menstrual cycles. This study aims to prove the value of cervical mucus methods for these women. Rather than examining a woman's onset of cervical mucus, this study evaluates the "Point of Change" in the mucus and its correlation to the woman's hormone levels.
In response to the lack of analyses of natural family planning (NFP) users in the UK a questionnaire was randomly distributed to teachers and users of this method in England and Wales in 1984-85. 464 of the 1000 questionnaires distributed were returned; the majority of respondents were married couples in the 25-34-year age group. Data on the demographic characteristics of these respondents countered the widely held belief that NFP users are predominantly Roman Catholics with large families. Only 59% of female respondents and 35% of male respondents were Catholic; moreover 65% had 2 pregnancies or fewer with an average number of 2.1. Specific NFP methods selected symptothermal (67%) Billings ovulation method (21%) calendar temperature (8%) and rhythm (3%). 52% reported previous oral contraceptive (OC) use. 260 respondents were using NFP only while 204 were combining NFP with the use of another method predominantly condoms. The primary sources friends (37%) the church (27%) and magazines/newspapers (17%); 74% were taught NFP by a trained instructor. The mean frequency of sexual intercourse per menstrual period--6.9 among exclusive NFP users and 7.9 among those who combined NFP with artificial methods--did not differ from that in the general population. 31% of female respondents and 20% of male respondents reported no problems with the requirement for abstinence during the fertile period; 78% said they had experienced no psychosexual problems as a result of NFP use. There were 179 unplanned pregnancies reported only 25 of which were method-related. An additional 34 pregnancies were regarded as resulting from inadequate training especially about NFP use post-OC postpartum and premenopausal.
A cross-sectional sample of women who had attended "at least one" instruction is utilized to assess dimensions of client satisfaction with instruction in and usage of natural family planning (NFP) methods (N = 440). Ovulation and symptothermal methods are represented by five autonomous programs in the state of Oregon. Psychosocial factors affecting experiences with natural methods are assessed using a mailed questionnaire yielding a 57% response rate and follow-up interviews with 28 couples from the initial sample. Findings yield an overall "effectiveness" rate of 94% for family-size limiters, and 88% for spacers. There was no difference in overall marital happiness between NFP users and discontinuers, although this may be more related to the overall high level of marital happiness for the total sample compared with the general population. Couples describe their perceptions of the effects of natural methods on marriage, communication patterns, sexual satisfaction, and family life. Implications for program development and research are explored.
In order to evaluate the relationship between the urinary luteinizing hormone (LH) surge as detected by the OvuSTICK (Monoclonal Antibodies, Inc., Mountain View, CA) method and daily cervical mucus parameters, ten spontaneously ovulating women undergoing infertility evaluation were followed during their cycles with twice daily urinary LH testing as well as daily ultrasound, mucus evaluation, and hormonal assays of serum LH, progesterone (P), and estradiol (E2). Maximal cervical mucus scores, as determined using a modified Insler score, were noted to coincide consistently with the urinary LH surge as detected by twice daily testing and to precede ultrasound evidence of ovulation by 0 to 24 hours. Mucus scores rapidly declined in the 24-hour period following the urinary LH surge. Detection of the urinary LH surge may therefore help identify that period of time during which cervical mucus parameters are optimal and therefore facilitate the timing of artificial insemination, intercourse, or postcoital testing.
Fertility AwarenessUrinary Hormone AssaysNatural Family PlanningHome-Based Immunoassays
It is now well accepted that a woman can conceive from an act of intercourse for a maximum of only about 7 days of her menstrual cycle. The reliability of natural family planning depends on identifying this window of fertility without ambiguity. Several symptomatic markers, cervical mucus and basal body temperature, have been used extensively and with considerable success in most women but failures occur. Ovarian and pituitary hormone production show characteristic patterns during the cycle. Urinary estrogen and pregnanediol measurements yield reliable information concerning the beginning, peak, and end of the fertile period, provided that the assays are accurate and performed on timed specimens of urine. We have developed such enzyme immunoassays for urinary estrogen and pregnanediol glucuronides that can be performed at home. In the early versions of the assays, enzyme reaction rates were measured by eye, but more recently, a simple photoelectronic rate meter has been used. The final problem to be solved is not technologic but whether women are sufficiently motivated to expend the same time and effort each day for 10 days a month, with less cost, on fertility awareness as they spend on making a cup of tea.
Fertility AwarenessBiological IndicatorsSymptothermal MethodHormonal and Clinical Markers
Indirect evidence of the occurrence of ovulation, which is generally accepted, is an increase in plasma or serum progesterone. Pelvic ultrasonography can estimate the probable time of ovulation within 12 h. There is a close association between the rise in progesterone, luteinizing hormone (LH) and oestrogen peaks and ovulation. A WHO study reported that ovulation occurred at a median time of 8 h after the rise in plasma progesterone, 15 h after the LH peak and 24 h after the oestrogen peak. The basal body temperature (BBT) method is the most effective in determining the premenstrual infertile period, but it is unreliable for an accurate determination of ovulation and the postmenstrual infertile period. Nor is BBT an effective method of predicting ovulation during postpartum lactational amenorrhoea. Therefore, BBT is usually used as a secondary indicator of ovulation and is combined with more reliable indicators. Observed changes in cervical mucus patterns can be used to define the probable fertile period, although this method produces a wide range of days. The peak mucus symptom is closely correlated with ovulation. Mucus symptoms can be used as a guide for the timing of blood or urine samples for estimation of LH, oestrogen and progesterone or their metabolites. Symptothermal methods incorporate other symptoms such as cervical changes, intermenstrual pain, breast tenderness and backaches, but these are secondary signs of ovulation and are recommended to be used in conjunction with mucus and BBT.
Fertility AwarenessOvulation MethodAbstinence and SatisfactionNFP Effectiveness Studies
During the 13-cycle effectiveness phase of a five-center study of the ovulation method of natural family planning, there were substantial differences, particularly between the two developed and the three developing countries, in the stated degree of satisfaction with the frequency of intercourse (most couples were satisfied in Bangalore, Manila, and San Miguel, whereas one-third of the subjects and half of their partners would have preferred more frequent intercourse in Auckland and Dublin) and in expressed difficulties associated with abstinence (e.g., 62% had occasional difficulty in Auckland, 14% in Bangalore, 55% in Dublin, 28% in Manila, and 5% in San Miguel). Cumulative net probabilities of discontinuation due to pregnancy were 1.8%, 18.6%, and 54.7% for couples in whom the male partner's degree of satisfaction was described as "no difficulty," "occasional difficulty," and "always some difficulty," respectively.
Fertility AwarenessSimplified Teaching MethodsLife Table AnalysisDeveloping Country Application
Researchers used life table rates from study and comparison groups from rural and urban areas of Cagayan de Oro City, the Philippines to test a simplified method of teaching natural family planning (NFP) defined by calendar, mucus, and cervix indicators. This method included a 6 page booklet, 2 30-minute training sessions, and a question and answer period. Fear of side effects from other contraceptive methods was the leading reason for using NFP (79.4% urban, 85.8% rural). Religious motivation and fear of side effects followed for urban couples, but the percentage was low (14.6%). In rural areas, religious motivation place 3rd (4.1%) preceded by other reasons (6.9%). User error resulted in low accidental pregnancy rates (.8%). Method failure was responsible for higher failure rates than user error, but they were still relatively low (3.4% total). In rural areas, the reason for failure was unclear in 2.6% of couples, but it was only .9% among urban couples. Rural couples who used NFP to space births (spacers) had 2 times the failure rate of those rural couples who used NFP to limit births (limiters) [69% vs. 31%]. Urban spacers had a higher failure rate than urban limiters, but the difference was smaller than it was for rural couples (54.8% vs. 45.2%). Lactation did not have a clear effect on failure rates. For example, in urban areas, partially lactating women had a lower failure rate than nonlactating women (41.9% vs. 58.1%), but in rural areas, lactation had the opposite effect (63.6% for lactating women and 36.4% for nonlactating women). Risk taking resulted in more 6 month pregnancy rates among urban couples than rural couples (12.3% vs. 8.2%). At the end of 6 months, 67.5% of all couples still used the new simplified NFP method (70.3% rural vs. 64.7% urban). Therefore the new simplified NFP method was an effective method for spacing or limiting births.
Body LiteracyAdolescent ProgramsOvulation MethodAdolescent Outcomes
Fertility awareness is experiential learning about cyclic fertility. This awareness, used as a family planning method, differs from contraception because it does not isolate the procreative capacity of either partner. The acceptability and effect of teaching fertility awareness on teen sexual activity and decision making was tested in a multisite pilot program which taught fertility awareness via the prospective marker of the cervical mucus (ovulation method of natural family planning). 200 US and 35 Guatemalan volunteer women ages 15-17 in a structured 1 year curriculum, monitored cycle charting and explored the implications of experiencing one's signs of fertility. Control subjects were recruited from the general population and from family planning clinics. 9% of the US study group were sexually active prior to entry. By cycle 12, 1/2 had discontinued activity. Conception rate was 0.0044. The continuation rate dropped from 90% at cycle 7 to 71% at cycle 8 due to scheduling constraints for 2 classes and to 57% at cycle 12. Postprogram follow-up of early leavers showed only 1/3 the expected rate of onset of sexual activity and pregnancy. Parent involvement correlated positively with postponement and/or discontinuation of sexual activity. Reported movement away from peer group pressure appeared 3 months after entry.
Body LiteracyNFP Training ProgramsProgram EvaluationPractitioner Training
This paper presents the main survey findings from a nationally representative sample of 607 users of periodic abstinence methods in the Philippines in 1984. The survey was conducted because of the widespread popularity of periodic abstinence in the Philippines and a lack of detailed knowledge about how the method is understood and practiced in the Philippines. Findings are presented on the prevalence of the different types of periodic abstinence methods, the nature of their use, knowledge about the various periodic abstinence methods, instruction received, perceived advantages and disadvantages, the husband's role, and the use-effectiveness of periodic abstinence both with and without backup methods. The implications of these findings for program management and for future research are also discussed.
Factors influencing the probability of conception after artificial insemination with donor semen were investigated in a series of 80 infertile couples. Overall, 46 pregnancies were achieved for a crude pregnancy rate of 58%. Life table analysis showed a cumulative probability of conception of 97.1% at the end of 12 cycles and an average fecundability of 15.1%. These results were achieved using a single insemination per cycle and individualizing the day of insemination based on the woman's basal body temperature. Women who had been pregnant previously had a significantly better fecundability than nulligravid women (P less than .05). The overall rates of conception in those women who required therapy for ovulatory dysfunction were the same as normal women although the fecundability was somewhat lower. Women who had abdominal pathology had an overall conception rate of 23%.
Natural Family Planning (NFP) is defined by the World Health Organization (WHO) as "methods for planning or avoiding pregnancies by observation of the natural signs and symptoms of the fertile and infertile phase of the menstrual cycle. It is implicit in the definition of natural family planning, when used to avoid conception that drugs, devices and surgical procedures are not used, there is abstinence from sexual intercourse during the fertile phase of the menstrual cycle, and the act of intercourse, when it occurs, is complete."(1) The fertile period may be determined by using Rhythm, a calculation based on previous cycles, basal body temperature (BBT) charting alone, mucus secretion alone (Billings or Ovulation method), or symptothermal charting (Serena method), which includes observation of both mucus and BBT. The effectiveness of each method is discussed, and the social and psychological profile of couples who use NFP is reviewed. Nfp methods can be used not only to avoid pregnancy, but also to achieve pregnancy and thus are particularly useful in investigating and treating infertility. The function of the Family Life Clinic at St. Michael's Hospital in Toronto is described.
Fertility AwarenessSymptothermal MethodBillings Ovulation MethodMucus Patterns and Fertility
Natural methods of family planning make use of the naturally occurring signs and symptoms of the fertile and infertile phases of the menstrual cycle. Recognizable signs and symptoms occur cyclically, and women can be taught to recognize them. Changes take place in basal body temperature, cervical mucus, and the cervix uteri. Basal body temperature rises about .2 degrees C (.4 degrees F) immediately after ovulation when the blood levels of progesterone increase. Following menstruation, cervical mucus is composed of cense cellular matter that forms an impenetrable barrier (typeG). As the cycle progresses under the influence of increasing estrogen, there is a predominance of characteristically lumpy opaque mucus (type L). A few days before ovulation, the characteristically thin slippery crystal clear stretchy mucus is produced (type S). Fertile mucus is composed of a combination of L-type and S-type mucus. Estrogen casuses changes to take place in the muscle and connective tissue of the cervix. As estrogen levels rise during the pre-ovulatory phase, the cervix softens and the cervical os opens. A woman can be aware of these changes by gently palpating the cervix with her finger tip. These signs and symptoms which reflect accurately the rise and fall of the hormones estrogen and progesterone are the basis of fertility awareness on which natural methods of family planning are based. In addition to knowing when ovulation takes place, it is also necessary to know the length of time the ovum can be fertilized after ovulation and the life span of the sperm in the female genital tract before ovulation. In fertile mucus, sperm will live an average of 3 days, but it must be understood that it is possible for sperm to survive for 5 days if conditions are right. To make allowances for sperm survuval, the fertile phase starts when follicular development begins and estrogen levels start to rise. The life span of the ovum is less than 24 hours. Natural family planning methods--including the temperature method, the ovulation method (Billings), the calandar method (rhythm), and the sympto-thermal method are explained.
In recent years increasing interest has focused on the symptoms that accompany normal ovulation. 'Identifying the accuracy ofthese symptoms as indicators of ovulation is of practical importance both to the subfertile couple trying to maximise the chance of conception and to the couple using" natural fiaily planiing" to prevent conception. Until recently it has not been possible to assess the accuracy of the symptoms because of difficulties in assessing the exact time of ovulation. Ovarian ultrasonography has now been shown to allow accurate …
The first study was done in which vaginal hormonal cytograms were correlated with cervical mucus symptoms as charted by women using the ovulation method of natural family planning. Daily vaginal smears obtained by 67 women during 78 menstrual cycles provided the basis of the study. The women had used the ovulation method for at least three cycles and were not breast-feeding. All vaginal smears examined cytologically had a microbiologic diagnosis of lactobacilli. All the vaginal hormonal cytograms revealed ovulatory-type patterns. Karyopyknotic index (KPI) peak correlated with peak mucus day +/-2 days in 74, or 94.9%, of the cases, with a mean of peak mucus at +0.14 days. The average number of mucus days prior to the KPI peak was 6.1. Seven women also provided daily blood specimens for bioassay of luteinizing hormone (LH). KPI peaked with a mean of 0.7 days after the LH peak.
NaProTECHNOLOGYProfessional TrainingNFP EducationService Development
There is no information available about the effect of iron in formula on the development of gastrointestinal humoral immune response in early human infancy. We compared standard Enfamil to iron-fortified formula during the first 8 weeks of human life on the development of local gastrointestinal humoral immune response by measuring fecal secretory immunoglobulin A (SIgA). Thirty children were studied and classified according plain Enfamil (n = 15) and Enfamil with iron (n = 15). Fecal specimens were analyzed at birth, 2 weeks, 4 weeks, and 8 weeks of age. Fecal SIgA was assayed by RID (radial-immune diffusion) during these four infantile periods in the two groups. Marked SIgA changes were detected in the group with iron-fortified formula versus non-iron-fortified formula. These changes appeared to have statistical significance in all the three infantile periods (2 weeks, 4 weeks, and 8 weeks). There were no observed clinical side effects with the use of iron-fortified formula as detected by appropriate questionnaire. The possible role of iron in earlier and enhanced development of immunologic competence and host defense is discussed. These data may suggest a beneficial effect of low-dose iron in formula during early infantile human life by the protective role of the earlier and enhanced production of SIgA in the gut.
Fertility AwarenessLactational InfertilityReturn of FertilityNFP Use-Effectiveness
The use-effectiveness of natural methods of family planning in lactation is evaluated by comparing the incidence of unplanned pregnancies in a group of nursing mothers practising these methods with the incidences reported previously in surveys of breastfeeding women using no contraception. The complexity of the physiological processes involved in the resumption of ovulation after term pregnancy is discussed in relation to NFP and the problems encountered by its users in the context of normal family life. The serum prolactin and gonadotrophin levels are correlated with the postpartum interval and nursing status of the participants and discussed in relation to NFP after childbirth.
A prospective six-year study (1975-1980) of 273 patients, monitored in the use of natural family planning (NFP), has shown that those with previously irregular menstrual cycles are disadvantaged in the subsequent use of the ovulation method after pregnancy in that they have fewer recognizable safe days and/or are more likely to have unplanned pregnancies than women who had regular cycles prior to pregnancy. Eight patients, seven nursing and one non-nursing mother, conceived during postpartum amenorrhoea. The reliability of memory in the recall of previous menstrual histories is discussed in relation to the results of an international study of menstrual cycles by the World Health Organization (WHO 1983). The relevance of prediction of menstrual events in natural family planning is also considered.
Fertility AwarenessNFP Status ReportEffectivenessBillings Method Effectiveness
The current status of natural family planning (NFP) was reviewed. There is renewed interest in NFP, and many couples who find other methods unacceptable for medical, safety, or personal reasons are turning to NFP methods. The percent of contraceptive users who rely on behavioral methods in developing countries in 35% in Peru, 20%-25% in Haiti, Philippines, and Sri Lanka, and average 7.5% for the remaining 23 developing countries. IN the US about 4.7% of all contraceptive users rely on behavioral methods. Worldwide, rhythm is the most commonly used form of behavior fertility control, but this method is not promoted by most NFP programs. The 3 modern methods of NFP are 1) the basal body temperature method, 2) the cervical mucus, or Billings method, and 3) the sympto-thermal method. All these methods rely on physical signs and symptoms to detect ovulation and require sexual abstinence during the fertile phase of the menstrual cycle. The basal body temperature method requires women to detect the slight rise in temperature which occurs at the time of ovulation. The method is 94%-97% effective if intercourse is restricted to the postovulatory phase of the cycle. Disadvantages of the method are that intercourse must be restricted to only 7-13 days of the cycle, women must take their temperature daily, the method cannot be used during fever episodes, and the method is inappropriate for use during lactation or near menopause. The cervical mucus method is based on observing cervical mucus changes during the cycle. These changes signal the fertile and infertile phases of the cycle. According to a World Health Organization study, 93% of the women instructed in the method were able to detect mucus changes, and illiterate women were as adept at identifying these changes as university graduates. Findings also indicated that the method was 97% effective if abstinence was practiced during 15 days of the cycle, but use-effectiveness was only about 80%. This method has the advantage of not requiring ovulatory regularity. The sympto-thermal method uses a combination of symptoms including temperature shifts and mucus changes to detect ovulation. Some studies indicate that the combined method is more effective than those methods based on only 1 symptom, but many individuals find the combined method difficult and confusing. The advantages of NFP methods are that they require no medical supervision and that they have no side effects. Family planning providers often have negative attitudes toward NFP and many programs do not provide NFP services. Many providers maintain that the methods are ineffective and difficult to apply and that there is little demand for NFP. Research should be undertaken to determine if these opinions are valid. The major source of funding for NFP programs and projects is the US Agency for International Development (USAID). The agency is currently supporting 22 NFP projects under USAID grants and another 16 bilateral NFP programs. The research undertaken in connection with these projects should provide needed information on NFP advantages, disadvantages, effectiveness, and demand.
Fertility AwarenessReturn of FertilityLuteal Phase AbnormalitiesPostpartum Monitoring
Luteal phase abnormalities in early menstrual cycles after pregnancy have been shown to cause confusion in the practice of natural family planning (NFP) for some patients and to restrict severely the number of late infertile days available to others. The cause of the abnormalities is uncertain but appears to be related to the nursing status of the patient.
Fertility AwarenessMethod ComparisonUltrasound vs BiomarkersDonor Insemination Timing
Ninety-five menstrual cycles were studied in 20 women undergoing donor artificial insemination (AID). In 49 cycles basal body temperature (BBT) changes were charted daily and both daily cervical mucus scoring (modified Insler score) and daily realtime ultrasonography (USS) were performed from day 11 to ovulation. AID was performed only on the day of follicular rupture. A control group, not subjected to USS, were inseminated two to three times per cycle over 46 cycles in the periovulatory period. The Insler score was found to be a reliable indicator of follicular development and rupture. The BBT was found to be less reliable than the Insler score or USS. While USS may be used to confirm follicular development, the Insler score is reliable and less costly.
Reliable indicators to detect the fertile and infertile phases in the menstrual cycle are now available, largely due to the intensive scientific research into fertility over the past decade. This means that couples who follow the rules of the different NFP methodologies have a highly effective means of birth control, without the introduction of hormones, chemicals or devices into the body. New scientific techniques can be expected within the next couple of years which will simplify the detection of the fertile phase and hopefully help to elucidate the grey area of the early fertile days, where most of the unplanned pregnancies occur. Fertility awareness by both partners is an important positive contribution to the whole sexual relationship and emphasizes that NFP is an educational delivery system rather than a technological one. The modification of sexual behaviour and the motivation of both partners for the successful use of NFP may initially present a problem to some couples. On the other hand, many partners find the discipline enhances their sexual relationship and dialogue. Whatever the motivation, today more and more couples are happier to be in autonomous control of their bodies and their fertility.
The author reviews and makes further recommendations for 3 points of the discussion in G. Freundl's pilot study of "Natural Family Planning (Symptothermal Method) and Objective Ovulation Indicators" published by Georg Thieme Verlag in Vlume 6, "Geburtshilfe und Frauenheilkunde," in 1984. It is suggested that the scientific basis of changes in methodological rules, such as the BT3 modified for the double control method in paragraph 3 of the discussion, must be reported Natural Family Planning (NFP) instructors in Bonn, West Germany, along with failure statistics whenever possible, to enable instructors to participate responsibly. In response to errors by users cited in paragraph 4 of the discussion, the reviewer asserts that adequate instructional materials (photos and slides) are available to acquaint the users with changes in cervical mucus and that personal guidance of a couple or small group should be carried out until detection of fertility signals is performed without difficulty and the couple has proved itself capable of abstaining for the required periods, the latter being the more difficult. The author further cautions that before shortening of the abstinence period can be promoted, instructors must be scientifically assured of the accuracy of the basal temperature -6 indicator. She emphasizes that user errors can be reduced with a shorter abstinence period, but that the couple demands reliable rules first and foremost. The author concludes with a call for closer cooperation between gynecologists and NFP instructors.
The Billings/ovulation method is a periodic abstinence method of regulating births based on the client's interpretation of changing patterns in secretions of cervical mucus monitored by external self-examination. It was developed in Australia and is now widely promoted overseas. This paper outlines the method's recent history and goes on to discuss its physiological basis, its use-effectiveness as measured in a number of major trials, and some evidence concerning its general acceptability and applicability in family planning programs.
Fertility AwarenessContinuation and DiscontinuationDeveloping Country ProgramsEducator-Client Relationship
Factors associated with discontinuation from an island-wide natural family planning program in Mauritius were examined in 2 stratified random samples of 300 (1976) and 350 (1980) acceptors. The data were gathered through records, educator observations, and field interviews with the 1980 sample. Comparison between those served by the Action Familiale program and characteristics of the Mauritius population as a whole suggests that the natural family planning program serves a somewhat better educated group of couples who have more employment security and smaller families than the general population. Acceptors selected the natural family planning method for reasons such as a desire to have a child according to a plan or to space children (29%), avoidance of the side effects of artificial contraception (21%), or as a result of a recommendation by a friend, relative, or professional (25%). 74% of acceptors in the 1980 sample expressed satisfaction with the method and indicated that their spouse shared this satisfaction. After 3.5-4.5 years of follow-up, 57% of acceptors in the 1976 sample had discontinued use of natural family planning. 9 variables in 4 categories--Administrative, Psychological-Motivational, Educator-Acceptor Relationship, and Family--were predictive of discontinuation. The major factors differentiating discontinuers 1) discontinuers had previously registered at Action Familiale and dropped out; 2) discontinuers placed more emphasis on spacing than on preventing pregnancies; 3) discontinuers discussed fewer topics with their educators; 4) discontinuers and their husbands seemed less interested in the natural method; 5) discontinuers had less family support for natural family planning; 6) educators experienced greater difficulty in teaching discontinuers; 7) discontinuers demonstrated less understanding of the symptothermal method; and 8) educators made fewer preregistration visits to the homes of discontinuers.
Fertility AwarenessUltrastructureScanning Electron MicroscopyCervical Mucus Changes
Interesting data on infertile human membranous mucus compared with infertile filamentous mucus have emerged from previous studies using scanning electron microscopy (SEM). The aim of this study was to obtain more information about the infertility of membranous mucus being independent of ovarian hormone stimulus. All different types of mucus, progressively secreted during the menstrual cycle by endocervical muciparous cells, were collected from the cervical canal of a fertile woman with a long menstrual cycle and specifically with a long infertile preovulatory period. The most significant results concern the identification of the cycle phase characterized by the presence of membranous mucus alone, i.e. the infertile preovulatory phase and the hormonal bases of membranous mucus infertility. The conclusion is reached that each ovarian hormone pattern stimulates the secretion of a specific type of mucus during the menstrual cycle.
InfertilityClomiphene Citrate Side EffectsHormonal InfluencesAnti-Estrogenic Effects
The antiestrogenic effect of clomiphene citrate (CC) on cervical mucus was evaluated in women receiving 150 mg CC daily for 5 days. Daily cervical mucus scores and serum estradiol (E2) concentrations were determined in control (n = 25) and CC (n = 24) cycles. E2 concentrations were significantly higher in the CC-treated women (mean +/- standard error of the mean, 1254 +/- 102 pg/ml versus 337 +/- 18 pg/ml, P less than 0.0001). Despite supraphysiologic E2 concentrations, however, cervical mucus scores were significantly reduced in the CC-treated group (P less than 0.01). These data indicate that CC exerts a direct suppressive effect on cervical mucus despite markedly increased E2 concentrations.
Fertility AwarenessCanalization PhenomenonFerning and Channel FormationMonitoring Methods
Cervical mucus forms channels when dried under a coverslip. The 1) to prove mucus canalization both in spontaneous ovulatory cycles and during ovulation induction with gonadotropins; 2) to prove the estrogen dependence of this phenomenon; 3) to check the importance of the proteidic and electrolytic concentration on chaneling; and 4) to use this phenomenon clinically, shortening the time in which it occurs. The number and arrangement of channels vary during the cycle. The phenomenon is estrogen-dependent. The comparison between estradiol values and the number of channels during spontaneous ovulatory cycles and treatment with gonadotropins showed a linear relationship. Treatment with estradiol 17 beta-valerate and ethinyl estradiol induced channel formation in women with primary amenorrhea. Canalization and ferning disappeared after dialysis or treatment with proteolytic enzymes. It follows that the two phenomena have similar characteristics. Canalization increases daily, as does estradiol, whereas ferning maintains the same grade for a longer period, and when a grade of + + + is reached, it provides no further indications. With the use of a thermostat, canalization occurred in only a few hours. Chaneling, a more precise index, could therefore substitute for ferning, particularly when monitoring the induction of ovulation.
The efficacy, the ability of Indian women to use the Billings' Ovulation Method, and its effectiveness in helping them to control their fertility was studied in a sample of urban poor living in the Delhi slums. No attempt was made to develop a design which would rigorously test the acceptability of the method because the question of the ability of poor women to define fertility and to avoid an unwanted pregnancy by avoiding sexual relations during the fertility period; and the efficacy and use-effectiveness of the modified method which had not been tested. The study, which extended over 36 months, recruited a sample of 5752 eligible acceptors of fertility living in the urban slums. Natural family planning (NFP) use requires recurrent decision making at 2 in the beginning of the menstrual cycle to check for signs of fertility; and to abstain from sexual relations in the fertility period. Age was an important variable in the use of sexual abstinence oriented methods and fertility determining methods. 192 of the acceptors were below 19 years, 1545 between 20-24 years, 2089 between 25-29 years, 1236 between 30-34 years, 520 between 35-39 years, and 170 between 40-44 years. Of 4380 of the 5302 acceptors in Treatment 1 who began to use the method after menstruation, 7 (0.16%) had a profuse discharge and could not distinguish the change in mucus because of cervicitis which was treated in cycle 2. 663 (5.4%) acceptors did not see or feel fertile mucus but noticed patches of infertile mucus throughout the cycle. 419 (69.19%) of them had a family income of less than Rs300 and 25 (3.77%) were open cases of pulmonary tuberculosis. 16 acceptors (0.37%) noticed wetness and lubrication characteristic of fertile type mucus for about 2 hours, 145 (3.31%) for 3-4 hours, and 218 (4.98%) for nearly half a day. 867 (19.79%) had 1 day, 406 (9.27%) 1-1/2 days, 939 (21.44%) for 2 days, 291 (6.64%) 2-1/2 days, 636 (14.52%) for 3 days and 187 (4.27%) 3-1/2 to 4 days of fertile mucus. 1 acceptor had 5 days of fertile mucus. 4 acceptors failed to check regularly and therefore may have missed the fertile period. In Treatment 2 the initial decision to accept the use of the method was made by the 450 husbands before instructing their wives. The continuation rate of 91.86% for 12 months with a standard error of 0.67% was surprisingly high for a sample with low literacy and occupational status, low female work participation rates, small family size and a preference for sons with low motivation to use other methods. There were 9 unplanned pregnancies classified as method failures--pregnancies which occurred in acceptors who followed the method accoring to the instruction but got pregnant. The 1 year efficacy rate (life table analysis) was 99.86%. The 1-year use-effectiveness rate was 97.43% for the 5752 cohort. The high efficacy rate of the method can be due to 2 the correct identification of the fertile mucus; and the ability to clearly distinguish between infertile and fertile mucus.
With the Billings Ovulation Method of natural family planning, women chart the symptoms of changes of their cervical mucus to determine when they are ovulating. The Ovulation Method is simple to learn, and some studies have shown it to be 98.5% effective. It can be used throughout a woman's child-bearing years. Unlike other methods of natural family planning, a woman need not have regular menstrual cycles to use the Ovulation Method. Usually, volunteer married couples trained in the method teach it; however, the physician's support can greatly increase the competence of these instructors.
The calendar rhythm method of natural family planning (NFP) is one of the most popular contraceptive methods in the Philippines. As a result, the Philippines has one of the highest NFP prevalence rates in the developing world. In recent years, family planning program officials have become increasingly interested in improving the practice of NFP, both by improving the quality of rhythm practice and by introducing newer, more accurate NFP methods. Over the years a substantial body of research data related to NFP practice in the Philippines has accumulated. This paper presents major findings from past research on NFP in the Philippines, discusses their implications for program management, describes current research, and suggests needs for future research.
Fertility AwarenessUser AttitudesPhilippinesFocus Groups
Two sets of focus group discussions on the advantages and disadvantages of the rhythm method were carried out in the Philippines in 1980 and 1981. The first discussions were held among 30 women and nine men 21-40 years of age, and the second among eight women 25-35 years of age who had voluntary pregnancy terminations after the method had failed. Among the perceived advantages of rhythm were that it permits spontaneous intercourse on the safe days and has no bad side effects. Among the perceived disadvantages were that it is ineffective, especially for women with irregular periods, and it requires abstinence. The women who had had voluntary pregnancy terminations discussed their motivations and rationales and the methods that they had used. The information obtained from the discussions formed the basis for support materials that are now used throughout the country.
The ovulation method makes women aware of certain changes in their cervical mucus. These modifications help to distinguish the beginning and end of the cycle's fertile period and indicate the time of maximum fertility. In addition to pinpointing the date of ovulation, the method permits the user to know she is not fertile when there is no ovulation. The principle of the method is the state of "basic infertility" which preceeds follicular development. The method cannot be implemented with success unless it is properly acquired. After some preliminary considerations regarding the fertile period, ovluation detection and periodic abstinence, some clinical and hormonal observations are compared in 2 basic studies in order to show to what extent cervical mucus reflects ovarian activity. The application of the method requires an understanding of the "basic infertility profile" and 2 sets of rules regarding the 1st days and the peak sign which indicate respectively the beginning and end of the fertile period. The criteria of an ideal birth control method and the importance of proper teaching are also dealt with. With regard to Natural Family Planning, 2 problems are pointed out--incomplete terminology in data collection and absence of a positive and detailed approach to periodic abstinence. (author's modified)
Fertility AwarenessBillings Ovulation MethodSympto-Thermal MethodClinician Role
Despite skepticism on the part of the health care delivery system, increasing numbers of women and couples are relying on natural family planning methods to avoid or achieve pregnancy. Most clients require 2-4 cycles to become familiar with the delineation of the fertile phase. Both the ovulation and the sympto-thermal methods are considered to have a method effectiveness of at least 98%. Teaching-related unplanned pregnancies fall below 5%. Use of the Billings ovulation method requires the couple to abstain from intercourse from the beginning of mucus until the 4th day after peak. The sympto-thermal method is preferred by those desiring a multiple-index approach. 75-80% of users of this method can detect cervical softening and dilatation, and 50% are aware of the change of position of the cervix. Knowledge of mucus buildup patterns can be expecially important for adolescents, lactating women, and premenopausal women in helping them to determine whether cycles are ovulatory. Instruction in interpretation of the mucus cycle is further advised in cases of infertility. Unwillingness of the partners to practice it constitutes the only contraindication to natural family planning. However, couples are advised to wait for the postovulatory infertile phase of the cycle to have intercourse in cases where prgnancy would pose a serious threat to the life of the mother or fetus. Although some groups recommend the use of a barrier method rather than abstinence during fertile periods, this practice makes mucus recognition more difficult and impedes confidence in the method. Attainment of couple autonomy in natural family planning involves 2 1) correct recognition of the signs of fertility and 2) comfort with periodic asbsinence. Successful autonomy is reflected in the high continuation rates found in programs that offer adequate counseling support.
When properly taught and practised, natural family planning can be a highly effective form of birth regulation. Recent studies indicate low failure rates of less than three pregnancies per 100 women years for couples with a strong motivation to follow the method. Studies show that pregnancy rates are high when the rules for avoiding pregnancy are not adhered to. Successful natural family planning can lead to heightened self esteem and marital enrichment.
Fertility AwarenessMethodology and InterpretationNatural Family Planning EffectivenessOvulation Indicators
Parenteau-carreau S, 1983·Contracept Fertil Sex (Paris)
The symptothermal methods include all those that identify the woman's fertile period through the basal body temperature and the periovulatory signs. Research conducted following the discovery over a century ago of the hyperthermic plateau in the later part of the menstrual cycle has confirmed that under normal conditions, and when the daily temperature is taken under comparable conditions, infertility may be assumed when the high temperature plateau is confirmed. A reliable temperature curve it should be taken upon awakening with a basal thermometer over a sufficient time to obtain an accurate measure, at almost the same time every day, and the graph paper should be appropriately scaled for recording. Various guidelines of interpretation have been developed throughout the world. Serena considers infertility assured from the 3rd consecutive day of elevated temperature as long as other fertility symptoms have disappeared. Among symptoms of ovulation that are perceptible to the woman are cyclic changes in the quantity and consistency of the cervical mucus, which has the advantage of predating and thus forecasting ovulation and of being less sensitive than the basal temperature to nongenital infections, sleepless nights, or other stresses. Use of mucus changes alone as an indicator of fertility carries the risk that such changes may not be noticed or may be due to an estrogen surge not related to ovulation. Other symptoms that are useful for some women in confirming temperature or mucus changes include 4 different alterations in the cervix, abdominal pain or mittelschmerz, intramenstrual bleeding, feeling of heaviness in the breasts, and variations in mood and libido. Many groups that teach the temperature curve and clyclical symptoms also provide instructions or mathematical rules for determining the number of infertile days at the beginning of the cycle. Some programs state that 6-7 days are usually infertile provided that the menses were preceded by a hyperthermic plateau. Many groups recommend the calculation of Ogino or a variant. The symptothermal method of fertility control combines the basal temperature curve with the other signs of fertility to serve as a basis for modification of sexual behavior to enhance or suppress fertility. Different programs stress different elements or combinations. The efficacy of the symptothermal methods depends on precise recordkeeping and observation and on competent instruction and counseling, as well as the willingness of the couple to modify their sexual behavior. Statistical measures of the method's efficacy are complex and unsatisfactory as they attempt to apply rigid rules to actions and decisions that are in fact filled with nuance.
Body LiteracyNursing and MidwiferySympto-Thermal MethodCycle Interpretation and Signs
All forms of birth control require some motivation, and motivation calls for understanding. If a woman learns to interpret her own cycles, her understanding of her body will be enhanced, and this could have benefits in all aspects of her fertility control. Professional nurses and health visitors are frequently expected to explain the intrigues of the menstrual cycle whether it be in family planning clinics, on gynecology wards, or in a client's home. When information about the monthly cycle is linked with the signs women observe in their own bodies, knowledge will result. With accurate knowledge about the span of the fertile phase, it should be within most women's grasp to control their own fertility, whether they use this knowledge alone or together with some mechanical contraceptive method. The endocrine hormones which control each menstrual cycle come from the pituitary gland and the ovaries, and they work in a feedback system, triggering each other. The start of the cycle is day 1 of the period when the pituitary gland starts the production of follicle stimulating hormone (FSH). This is taken in the bloodstream to the ovary where, as its name implies, it stimulates the ripening of follicles, each of which contains an egg cell. Operating in a feedback system, estrogen is carried back to the pituitary gland where it then causes a lessening in the production of FSH and stimulates the release of the luteinizing hormone (LH). LH proceeds back to the ovary and together with estrogen suppresses the growth of all the follicles except one, which then matures to release an egg at ovulation. If the egg is not fertilized, the pituitary gland detects the high level of progesterone and ceases production of LH, which causes the corpus luteum to die away. The 1st phase of the cycle leading up to ovulation is known as the follicular phase, and its length can vary considerably from month to month. The 2nd phase, leading up to menstruation, is the luteal phase, and its length does not vary more than 12-16 days, normally 14. There are 3 main observations daily temperature; the cervical mucus; and a "calendar" assessment, and after a few months the likely course of the cycle is evident. Each of these 3 ways of interpreting cycles are reviewed in detail. If the motivation and understanding is there, most women can become adept at reading the signs each month. While still learning, it is important to seek advice from those who understand the methods and can ensure accurate interpretation. Encouraging women to discover how their bodies work is not aimed at discouraging the use of mechanical or chemical contraceptive methods. It is simply a way to enhance a woman's understanding of her body which could bring her positive physical and emotional benefits. Practically, if more women could read their body cycles, there would most likely be an increase in motivation to use contraception and an associated reduction in unwanted pregnancies.
Fertility AwarenessComprehensive ReviewMethod ComparisonPublic Health Programs
There is renewed interest in natural family planning (NFP) as the Philippine Population Program enters the 1980s. Much of this interest is due to the realization that, properly practiced, NFP can be a highly effective means of birth spacing. In 1978 the Special Committee to Review the Philippine Population Program recommended that more efforts be made to promote NFP. The different methods of NFP are reviewed. Sex without intercourse, coitus interruptus, and prolonged nursing are not officially recognized as NFP methods by the Program. The rhythm method was first described independently by Drs. Hermann Knaus of Austria and Kyusaku Ogino of Japan in the 1930s. Ogino's method of calculating a woman's fertile period is based on the lengths of the last 12 menstrual cycles which she recorded on a calendar. The advantages of rhythm are that it is inexpensive, it requires only the cost of charts which may be homemade, there are no physical side effects, control is in the woman's hands, and it is acceptable to people who consider it their duty to follow religious teachings. keeping constant, accurate records of cycles for long periods of time; the need for perseverance and correct interpretation of the chart; the possible need for medical advice and help; and the fear that something might upset a woman's cycle and change the time of ovulation. The continuation rates of rhythm acceptors in the Philippines are unimpressive. A study of 142 women revealed a high pregnancy/failure rate--25% for a 12-month period compared to 0 with oral contraception (OC) and the IUD's 2%. The basal body temperature method helps determine the unsafe period with some accuracy. Its premise is that there are slight but detectable changes in a woman's body temperature during her cycle. These changes herald ovulation. A special thermometer must record temperature changes of 0.1 degree Farenheit. This instrument and the charts are the only expenses involved. The reviewers of the Philippine Population Program noted that since the end of the unsafe period can be indicated only by the temperature, the total period of abstinence becomes long, although the basal body temperature method gives more or less 10 successive days for intercourse. The cervical mucus method, also known as the Billings method, takes into account the cervical secretions during the menstrual cycle. Appearance of this mucus is an indication of fertility. All that is required of a practitioner is to learn to distinguish the different sensations of wetness and dryness. The disadvantage is that the method becomes ineffective in areas where there is cervicitis or infection of the cervix. The symptom thermal method is the basal body temperature method combined with other NFP techniques and is widely used. With this method an accurate record of the 6 immediately preceding menstrual cycles is established. The start of the fertile period is set by substracting 20 days plus 1. The woman watches for symptoms like pelvic heaviness, breast softness, and mucus discharge.
Fertility AwarenessStructural Changes and HormonesCervical Mucus MorphologyCervical Mucus Observation
In studying the structural changes of human cervical mucus during the ovulatory cycle, they have been observed to be directly related to ovarian hormone changes. Mucus structural changes, if taken according to their sequence during the cycle, clearly express the anatomic and functional events occurring in the ovary. If each structure is considered separately, only the mucus of the preovulatory period can be considered an indication of the corresponding ovarian processes, presenting peculiar morphologic characteristics. The observation of a similar morphologic appearance in the mucus of the early follicular and luteal phases leads one to believe, in spite of the influence of totally different hormone levels, in the likely existence of a mechanism of interference between estrogens and progesterone during the postovulatory period of the cycle.
Frequently, when one mentions natural family planning methods, the response is doubt, bewilderment, ridicule, or scorn. Much of this is due to the fact that many people know only of the rhythm method, which depends on a calculation based on the menstrual pattern. What many people do not know, including physicians and nurses, is that in Australia Drs. John and Lyn Billings have been scientifically researching natural methods of family planning for 25 years, and they have pioneered this Ovulation Method of family planning. The Billings Ovulation Method depends only on the mucus sign. It is based on a scientific knowledge of the combined fertility of husband and wife, and an understanding of the physiology of the female body through simple observations. Important facts relating to the ovulation takes place only once in the cycle; mucus is secreted by the cervical mucosa before ovulation; the ovum lives for only 3 days at the most; and the sperms live for 5 days at the most, and only in the presence of this fertile mucus. There a 2 types of mucus. The 1st type to appear is cloudy or white. It is nonslippery, sticky, and breaks when stretched between 2 fingers. The 2nd type is like the part of a hen's egg. It is very slippery, much clearer than the former, and stretches when pulled between 2 fingers. This is fertile mucus, and ovulation occurs on the last day that this is present. Of course, it cannot be recognized as the last day until its absence is observed on the following day. The mucus sign can be both seen and felt. After a few months a woman will readily recognize her fertile time, but daily charting is advocated. Simple signs, representing the various observations, are taught. Once a couple knows and understands their combined fertility through the observation of the mucus sign they can plan their family. Rules of the method are outlined. The self control required by this method can only serve to increase the selfless love and unselfish care and respect between partners.
Fertility AwarenessTerminology and DefinitionsCore CurriculaNFP Effectiveness Definitions
22 physician-providers who serve natural family planning (NFP) programs, mostly in the private sector, gathered to formulate a standard terminology for the field. The Billings and sympto-thermal methods are the 2 methods taught by this group. The sypto-thermal method helps a woman predict ovulation by detecting changes in her cervical mucus and in the cervix itself. Ovulation is confirmed by monitoring the temperature shift as well as by observing the cessation of mucus buildup, closing of the cervix, and firmness of the os. Those women using the Billings ovulation method predict fertility by the appearance of the cervical mucus, its sensation, color, and elasticity. Sperm will only survive if the cervical mucus is of the fertile type. It is also helpful to recognize mucus patterns of anovulation during breastfeeding, weaning, and premenopause. Use-effective rates which only reflect pregnancy are inadequate in evaluating NFP. A series of definitions are presented which in the future will help to analyze NFP data to accurately reflect NFP effectiveness. total pregnancies, planned pregnancy rate, pregnancy avoidance, method effectiveness rate, method-related pregnancies, informed choice pregnancies, teaching-related pregnancies, and unresolved pregnancies. All NPF teaching programs include instruction in basic reproductive physiology and in the recognition of the fertile phase. The cervical mucus factor is emphasized in ovulation method groups while thermal and other parameters are given equal weight in the sympto-thermal groups. It is the intent of NPF to teach couples to distinguish the fertile phase by using the fertility markers and to have them integrate this information into their sexual decision making. Success is dependent on teacher skill and the ability to inspire confidence in the method. Recognition of the mucus patterns of ovulation and anovulation are crucial in assessing infertility. All family providers under Title 10 must by law offer either NFP instruction or referrals to sites which do. A directory of non-Title 10 providers of NFP Services is available for $4.00 from the Human Life and NFP Foundation, 205 South Patrick Street, Alexandria, Virginia, 22314.
The concept of utilizing changes in cervical secretion offers a potentially simple method of natural family planning. A detailed international trial has been conducted to test the effectiveness of the method. 5 Auckland; Bangalore; Dublin; Manila; and San Miguel. The observations provide an indication of the value and success of the method. They also reveal interesting variations between the different centers and between various socioeconomic classes. The work was divided into a teaching phase and an effectiveness phase. The initial phase was designed to teach individual women how to recognize the symptoms in cervical mucus, and it usually covered the first 3 complete cycles. The subjects were ovulatory, of proven fertility, less than 39 years, nonlactating, and with a history of a menstrual cycle of between 23 and 35 days. Data were collected from the patient and returned to the organizers for analysis. Comparisons were then made between different centers on the 2 study phases. In the teaching phase 94% of the women could soon recognize and record their own cervical mucus symptoms. Many women could understand the principle of the method within the 1st teaching cycle. Almost 90% of the subjects completed the teaching phase, and 7% discontinued for various reasons, including 1.3% who failed to learn the method, and 5% who became pregnant. The average number of days of abstinence by the method was 17 in the 3rd teaching cycle, a high proportion of the length of the average menstrual cycle. After the teaching phase, 725 subjects were studied in an effectiveness phase which lasted for 13 cycles. More than 7500 cycles were analysed. High rates of method failures were found in the 2 most socially developed centers, Auckland and Dublin. Pearl rates for method failure ranged from 9.4/100 women years in Auckland to 1.1 in Manila and 0 in Bangalore and San Miguel. The accumulative probability of discontinuation after 13 cycles was 35.6%, more than half of this figure being due to pregnancy. Detailed pregnancy rates/100 woman years, using the modified Pearl Index, conscious departure from the rules of the method, 15.4; inaccurate application of instructions 3.5; method failure 2.8; inadequate teaching 0.4; and uncertain reasons 0.5. Subjects were not selected randomly.
Wade et al.'s report, entitled "A randomized prospective study of the use-effectiveness of 2 methods of natural family planning," contains items worthy of emphasis. 1) less than 5% of the women in the study were prevented from using the method assigned them because of problems in identifying their cervical mucus pattern; 2) those who were unable or unwilling to adhere to the methodology were encouraged to drop out; 3) the largest single category of pregnancies occurred in both groups when the volunteers failed to follow the rules for avoiding pregnancy; 4) it was judged that there were 6 pregnancies in the ovulation method group to be classified as method failures, apparently for a total of 4501 cycles, which gives a method-failure rate of 1.6%; 5) couples were required to sign an informed consent statement of their awareness that the chances of the occurrence of pregnancy could be as high as 25% for the ovulation method; 6) recruiting difficulties constituted an important finding, primarily because they were unexpected by the investigators; 7) the volunteers recruited into the trial were restricted to those women whose menstrual cycles were 24-36 days; 8) the couples who failed to continue with the use of these 2 natural methods--ovulation and temperature rhythm--were on the average younger, more sexually active, and had fewer children; and 9) the ovulation method brings the partners into confrontation with their fertility in each cycle, and this has marked psychological results, including an awakening of the suppressed desire for that fertility to become creative of human life.
The importance of predicting human ovulation for either optimizing or avoiding conception has been considered from an endocrine, morphological and clinical view point. Of the biochemical markers in peripheral blood, a knowledge of the LH peak is the most clearly defined, with a two to four fold increase above baseline levels for a relatively short 24-30 hour preovulatory period. Ovulation is considered to occur 28-36 hours after the beginning of the LH rise or 8-20 hours after the LH peak. Daily assessment of the rise in preovular oestrogen reflects Graafian follicle development but the rise is less distinct and spread over 3-4 days with marked day to day fluctuations. LH induces a marked reduction in oestrogen production some 12 hours prior to ovulation and at the same time induces a two to three fold increase in progesterone production above baseline levels. While these changes in themselves are not great enough for day to day discrimination, a knowledge of their reciprocal relationship may be. The preovular rise in FSH is relatively small compared to LH and the radioimmunoassay technique has not generally been refined to be as rapid and reliable. Monitoring the day to day growth of the preovular follicle ultrasonically is both linear and potentially predictable but there is a wide range of its final diameter (17-26 mm) prior to ovulation making prediction inaccurate. With further refinements in ultrasonic resolution, detection of intrafollicular changes of the cumulus oophorus and granulosal cell layer configuration and thickness may give a closer prediction of the time of ovulation. At a clinical level a knowledge of menstrual cycle length in association with body messages which herald ovulation are useful and may forewarn that ovulation in terms of days is approaching. Such markers as preovulation pain, the detection of periovular cervical mucus and the change in physical character and position of the cervix are reliable signs of preovulation for many well motivated and informed women for either promoting or avoiding conception. A knowledge of the basal body temperature is not a prospective guide to ovulation, but once the thermal shift is established in association with loss of periovular mucus symptoms, the fertile period can be considered to have passed. Because we do not have a precise and simple marker of human ovulation, it is necessary that the most suitable marker of preor postovulation is chosen for the particular need in a given individual.
This review of natural family planning (NFP) components of the fertile phase; sympto-thermal methods; the history and methodology of NFP (calendar rhythm, basal body temperature, cervical mucus--the Billings Ovulation method); special circumstances--periods of erratic ovulation (puberty, lactation, premenopause, discontinuation of ovulation suppression, cervicitis and vaginitis, ovulation suppression by stress and pharmaceuticals); effectiveness of natural family planning; achieving pregnancy; achieving couple autonomy (confidence in the method, periodic abstinence, dynamics of the learning process, and support systems); problem areas; and delivery systems. The number of users of NFP methods increased from 2.8% of currently married couples in 1973 to 3.4% in 1976. In 1979, 75,000 new clients received training in contemporary NFP, while the number increased to over 100,000 in 1980. NFP is planning for achieving or preventing a pregnancy by the timing of intercourse. A couple can, by observing and recording certain natural symptoms and bodily changes that occur in a woman's menstrual cycle and using the information as a guide, learn to identify fertile and infertile phases in the menstrual cycle. Precise prediction of ovulation forms one of the components of delineation of the fertile phase. Billings pioneered the use of cervical mucus as a single parameter for the prediction of ovulation and its application to NFP. Women are instructed to observe their mucus patterns at the vulva, relying primarily on the sensation of wetness and lubrication, the use of the Kegel exercise, palpation with the finger, a "wipe-through" with toilet paper, or a combination of these observations. In the absence of ovulation, the usual changing mucus pattern is also absent. NFP can be used either to achieve or to avoid pregnancy. When NFP is used to avoid pregnancy, one will encounter method-related pregnancies, teaching-related pregnancies due either to poor teaching or poor learning or both. The major use effectiveness studies are listed in table form, and the results are shown under new headings. To achieve pregnancy, it is the general practice of NFP instructors to teach women to recognize and record their fertility signs and to suggest some months of merely concentrating coitus at the time of maximum fertility. Mastery of NFP calls for both identification of the fertile phase and integration of that knowledge into the couple's sexual decision making and behaviors. Studies are reviewed in terms of the spectre of genetically damaged offspring. NFP instruction is available in nearly every country outside the Soviet bloc.
Meier-Vismara E et al., 1982·Geburtshilfe Frauenheilkd
During the last decade, the World Health Organization has paid increasing attention to some reliable methods of birth control based on periodic abstinence. There are 2 main methods of natural family planning--the Sympto-Thermal method and the Billings Ovulation method. The latter is explained in this paper. Its scientific basis, use, effectiveness, and importance as a birth control method as well as for understanding certain types of infertility are discussed. (author's)
Fertility AwarenessOvulation Method (Billings)Comparison of NFP MethodsCervical Mucus
Past practices of Natural Family Planning (NFP) have 1) calendar rhythm in which a constant mathematical relationship was calculated between the day of ovulation and the beginning of the succeeding menstrual period, 2) temperature rhythm in which sexual intercourse is permitted by observing that the basal body temperature rises at the time of ovulation, 3) a combination of calendar and temperature rhythm methods, 4) paper test strips which measure glucose and electrolytes in vaginal secretions, 5) electronic devices of various sorts which record changes in the potentials of the pelvic organs at the time of ovulation, and 6) recent developments in computer technology which measure a number of variables. All of these techniques depend upon the identification of the fertile and infertile periods of the menstrual cycle. More recent studies by the World Health Organization have analyzed the teaching phase of NFP and the effectiveness phase of NFP using the detection of ovulation by following changes in the quality of cervical mucus. These studies tested 869 women with varied backgrounds in 5 countries. The data support the fact that many motivated women can detect ovulation reasonably accurately by following changes in their cervical mucus (the Billings method), although teaching time and motivation are considerable. Long-term and detailed data are necessary to determine the value of these methods. The advantage of NFP is the avoidance of drugs and devices. Disadvantages are that demands are placed on the sex life of couples, and there are associations between failures and increased rates of congenital abnormalities.
Fertility AwarenessPostovulatory Infertility IdentificationPeak Mucus Symptom ResearchCervical Mucus and Ovulation
The estimated time of ovulation (ETO) was correlated with the day of defined postovulatory infertility in 66 hormonally normal menstrual cycles from 24 subjects for each of 15 different natural family planning methodologies. Inherent weaknesses were identified in methods based upon calendar calculations or basal body temperature only. These weaknesses could be removed for the basal body temperature-only methods if symptoms, especially the peak mucus symptom, were added to the temperature records. However, the peak mucus symptom alone had the greatest precision of all methods studied. No advantage could be identified in combining the basal body temperature with the peak symptom.
Fertility AwarenessGenetic Risk AssessmentNatural Family Planning Moral DebateFertility Regulation Safety
Genetic errors of many kinds are connected with the reproductive processes and are favored by a nunber of largely uncontrollable, endogenous, and/or exogenous factors. For a long time human beings have taken into their own hands the control of this process. The regulation of fertility is clearly a forceful request to any family, to any community, were it only to lower the level of the consequences of genetic errors. In connection with this request, and in the context of the Congress for the Family of Africa and Europe (Catholic University, January 1981), 1 question must still be raised and possibly answered. do or can the so called "natural methods" for the regulation of fertility increase the risks of genetic errors with their generally dramatic effects on families and on communities. It is important to try to give as far as possible a scientifically based answer to this question. Fr. Haring, a moral theologian, citing scientific evidence finds it shocking that the rhythm method, so strongly and recently endorsed again by Church authorities, should be classified among the means of "birth control" by way of spontaneous abortion or at least by spontaneous loss of a large number of zygotes which, due to the concrete application of the rhythm method, lack of necessary vitality for survival. He goes on to state that the scientific research provides overwhelming evidence that the rhythm method in its traditional form is responsible for a disproportionate waste of zygotes and a disproportionate frequency of spontaneous abortions and a defective childern. Professor Hilgers, a reproductive physiologist, takes on opposite view, maintaining that the hypotheses are arbitrary and the alarm false. The strongest evidence upon which Fr. Haring bases his moral principles about the use of the natural methods of fertility regulation is a paper by Guerrero and Rojos (1975). These authors examined, retrospectively, the success of 965 pregnancies which occurred in women who were using the temperature method for family planning and who had recorded the menstrual day of insemination, and they concluded that their results suggested that aging of human spermatozoa in the female genital tract is associated with a increased frequency of spontaneous abortions and that postovulatory aging of human ova results in postimplatation. Their results and conclusions were accepted with great caution by the scientific community. The kind of evidence which suggests that the use of natural methods may increase, in particular cases, the loss of embryos or fetuses, stimulates further research, but it seems a very weak basis for the establishment of principles of human behavior. At the present stage of knowledge the natural methods for the regulation of fertility cannot be qualified as methods which necessarily and considerably increase the risks of abortion of malformed progeny.
The percentage of 869 women in five countries capable of being taught to recognize the periovulatory cervical mucus symptom of the fertile period was determined in a prospective multicentre trial of the ovulation method of natural family planning. The women were ovulating, of proven fertility, represented a spectrum of cultures and socioeconomic levels, and ranged from illiteracy to having postgraduate education. In the first of three standard teaching cycles, 93% recorded on interpretable ovulatory mucus pattern. Eighty-eight per cent of subjects successfully completed the teaching phase; 7% discontinued for reasons other than pregnancy, including 1.3% who failed to learn the method. Forty-five subjects (5%) became pregnant during the average 3.1-cycle teaching phase. The average number of days of abstinence required by the rules of the method was 17 in the third teaching cycle (58.2% of the average cycle length). To what extent the findings of this study can be extended to other couples remains to be demonstrated.
Several periovulatory symptoms sometimes used in natural family planning are correlated with the estimated time of ovulation in 23 subjects and 64 hormonally normal menstrual cycles. The data suggest that intermenstrual pain may not be due to 1 specific cause but rather to several related factors. As a symptom of ovulation, intermenstrual pain was more specific than lower backache, abdominal bloating, and intermenstrual bleeding nonetheless, intermenstrual pain has a broad periovulatory association. The most reproducible and predictable sign of this series appeared to be the postovulatory occurrence of breast tenderness.
DiagnosticsOvarian Ultrasound MonitoringFollicular Development TrackingSonographic Methods
Serial sonographic examinations were performed on 15 volunteers five days during the expected midcycle. The 75 sonographic studies were evaluated in a nonbiased manner, and the following 1) the presence or absence of a follicle within the ovary; 2) if present, the average dimension of the follicle; 3) the ability to delineate both ovaries; and 4) the presence of associated changes, such as involution of the follicle, echogenic texture within the follicle, or fluid in the cul-de-sac. The sonographic findings were correlated with serial leutinizing hormone (LH) assays as well as basal body temperature charts. As defined in the study, the correlation between the sonographic findings and hormonal determination were considered excellent in 70% of the cases, good in 20%, and poor in 10%. Both ovaries were delineated in 73% of the examinations performed, thus substantiating the ability of sonography to detect maturing ovarian follicles.
27 healthy young Italian women were studied to evaluate their ability to identify symptomatically the potentially fertile phase of the menstrual cycle by self observation of their cervical mucus pattern as described in the Ovulation Method Billings. The women's observations were correlated with daily plasma levels of FSH, LH, estradiol-17 beta and progesterone. Ovulation was considered to occur on the day following the LH peak. The hormonal assays revealed that 2 of the 34 cycles studied were anovulatory. 24 of the 27 subjects in the study group demonstrated their ability to recognize the onset of the mucus discharge and the peak symptom from the first cycle after teaching, another two from the second cycle. The only other subject contributed an anovulatory cycle in which the hormonal assay confirmed the accuracy of her mucus observations. In the study, the mean interval between the time of ovulation as assessed and the peak symptom recorded by the subjects was 0.0 days, with a range from -2 to +1 days. The mean time interval from the first recorded symptom to the estimated day of ovulation was 6.0 days, with a range from 3 to 10 days. The study shows that young Italian women can be taught to recognize their cervical mucus pattern as described in the Ovulation Method Billings. The accuracy of their observations is demonstrated by the hormonal assays. The study also confirms the conclusion reached in earlier similar studies that there is a direct correlation between the cervical mucus symptom and the potentially fertile phase of the cycle. Research is currently being conducted on a larger number of couples employing the Ovulation Method Billings to actually regulate their fertility.
The fertile period of the human menstrual cycle consists of those days on which sexual intercourse can result in a pregnancy. Its duration is determined by the functional life span of the gametes within the female reproductive tract. Various mechanisms control gamete transport and survival in the reproductive tract of the human female. The ovarian hormones estradiol and progesterone have an important role in regulating these mechanisms. The nature of cervical mucus and its governing influences on sperm transport and survival following coitus are of prime importance in defining the fertile days of the menstrual cycle. Man's early concepts of the fertile period were often based on erroneous theories of the female reproductive cycle. It is only since the late 1920's that a true understanding of ovulation and the menstrual cycle has evolved. Current approaches in natural family planning to recognizing the fertile and infertile days of the menstrual cycle are discussed and evaluated.
A 2-year international study involving NFP (natural family planning) associations in 5 countries (Canada Colombia France Mauritius U.S.) was conducted to evaluate statistically the effectiveness of the sympto-thermal method an NFP method which adds to the temperatiure method the observation of signs and symptoms of the ovulatory period. 1022 couples (21736 couples) were selected 1) the wife had to be between 19 and 44 years of age 2) the wife had to be of proven fertility by having carried a fetus for at least 28 weeks 3) the couple must have submitted 1 satisfactory temperature graphy before being accepted and 4) the couple must have expressed a willingness to submit temperature graphs for 2 years. 826 couples completed 24 months. Menstrual cycle length varied from 9 to 98 days with an average of 28.43 days. 205 women had a variation of 8 days or less. 128 unplanned pregnancies occured giving a rate of 7.47 conceptions/100 woman-years of exposure. Theoretical effectiveness was .93 pregnancies/100 woman-years using the Pearl Formula; 16 pregnancies occured in couples following instructions. Failure rate was 4.13% for couples trying to prevent pregnancies and 14.83% for couples only delaying a pregnancy. Failure rate of the method used alone was 7.16%; 8.19% used with other contraceptives. There was an average of 13 cycles per year per woman. Using the modified Pearl index (pregnancies per 1300 cycles rather than per 1200 months) the pregnancy rate was 7.66% vs. 7.47% for 1200 months. The study shows that the sympto-thermal method is effective and reliable. 2 1) whether a large group of people will accept a method that depends on periodic abstinence or 2) whether the method will be just as effective when used by couples who are not as well motivated as the participants in this study.
Fertility AwarenessCervical Mucus ObservationBiomarker of FertilityMucus Pattern Recognition
The ovulation method provides a woman with an awareness of her cervical mucus pattern. This enables her to mark the beginning and end of the fertile phase of the cycle as well as the time of maximum fertility. Not only is the time of ovulation located but also there is recognition of infertility in the absence of ovulation. The key to understanding is the concept of the basic infertile pattern which precedes the commencement of follicular development; the key to successful use is competent teaching. After preliminary considerations on the fertile phase the determination of ovulation and the aspect of periodic abstinence two basic studies comparing clinical and hormonal observations are reviewed showing how accurately the cervical mucus reflects ovarian activity. Understanding the basic infertile pattern and the two sets of rules (the early day rules and peak rule identifying respectively the beginning and end of the fertile period) is basic to the application of the ovulation method. Criteria for the ideal family planning method and the importance of quality teaching are presented. Two problems requiring attention in NFP are restrictive terminology in data collection and a lack of fully developed and positive approach to periodic abstinence.
Fertility AwarenessEducationInternational Practice
Open Access
Now that principles of NFP have been established specific programs are necessary to disperse information and to teach techniques. The hospital-based NFP program offers the community a needed service and benefits the hospital.
Healthy volunteers with regular ovarian function, women taking oral contraceptives, and infertile patients being treated with clomiphene were studied longitudinally from day 7 of the cycle to menstruation. The main objective was to determine whether ovulation or failure to ovulate could be detected accurately by the use of ultrasound. The ovaries were scanned with a Kretz Combison 100 sector scanner every 1 to 3 days for morphologic changes consistent with follicle development, ovulation, and development of the corpus luteum. The morphologic changes were correlated with daily urinary hormone profiles. The estimated times of ovulation according to ultrasound and luteinizing hormone peak overlapped by 24 hours in 19 of 23 normal cycles and in 5 of 6 cycles of patients treated with clomiphene. Both techniques indicated that three of three women taking oral contraceptives did not ovulate. The ultrasound studies indicated a wide range in the diameter of the preovulatory follicle, which precludes follicular diameter as a single index for prediction of ovulation. However, by measuring the maximal diameter of the follicle and observing the morphologic changes within the ovary from follicle to corpus luteum, it was possible to detect ovulation in more than 80% of cycles studied. This technique was found to be quick, inexpensive, and efficient.
Fertility AwarenessBillings Ovulation MethodComparison of NFP MethodsMucus-Based Fertility Monitoring
Twenty-five women scheduled for hysterectomy for nonmalignant disease participated in the study. Sperm storage in endocervical crypts was examined nine women pretreated with estrogen and inseminated with normal semen, nine women pretreated with gestagen and inseminated with normal semen, and seven women pretreated with estrogen and inseminated with abnormal semen. The number of crypts containing spermatozoa (colonized crypts) and the sperm density per crypt were examined in serially sectioned cervices. In estrogen-pretreated cervices both the percentage of colonized crypts and the sperm density were significantly higher than in gestagen-pretreated cervices. Large and giant crypts proved to be the main storage facility for spermatozoa. The localization of crypts along the endocervical canal did not influence sperm storage. The quality of semen appeared to be of critical importance to sperm storage. The percentage of colonized crypts and sperm density were severly reduced in patients inseminated with abnormal semen.
Fertility AwarenessOvulation DetectionTemperature-Based Ovulation EstimationHormonal Correlation with BBT
Four points on the basal body temperatures (BBT) curve have been correlated with the estimated time of ovulation (ETO), as determined by indirect hormonal parameters, in 74 menstrual cycles from 24 subjects. Only 10 of 66 hormonally
NaProTECHNOLOGYPeak Mucus Symptom DefinitionUse-Effectiveness MethodologyQuality Control in NFP Trials
I read with interest the recent article by Wade and associates, "A randomized prospective study of the use-effectiveness of 2 methods an interim report" (134: 628, 1979). In reference to the study of the ovulation method, the authors noted that abstinence begins on the 1st day of mucus secretion and continues until the evening of the 4th day beyond the peak or maximal mucus secretion. In the ovulation method, the peak symptom is not the same as maximal mucus secretion as was indicated in the paper. The peak symptom is defined as the last day of the mucus discharge that is clear and/or stretchy and/or lubricative. In the definition of peak symptom, the amount of mucus discharge is not specifically important and may often be misleading. I had the opportunity to do a site visit at this study at the request of the National Institutes of Health while the study was in progress. I analyzed several pregnancies which occurred in users of this ovulation method. Some of the pregnancies occurred as the result of poor teaching of the concept of peak symptom. In the ovulation method, proper understanding and teaching of that concept are essential to the measurement of its effectiveness. Noticeably missing from this interim report was any discussion of the quality control procedures which were utilized to guarantee a high-quality educational service to the people entered into the study. While the authors claim that the methods were taught by professional teachers, these teachers were actually women who had previously used the method and/or had formalized training in teaching the method. Simple use of either of the methods certainly does not qualify an individual to teach natural family planning. For those with formalized teaching, such training should have been outlined since judgment on the effectiveness of the teaching cannot be made; such a judgment is essential to the proper analysis of results. Finally, while the study claims to be a use-effectiveness study, it is rather a modified version of extended use-effectiveness. No objective definition of "user failure" is provided. One cannot ascertain how many pregnancies were related to poor teaching, nor can one tell how many occurred as the result of the couples' last minute exercise of their freedom to use their fertility. The use-effectiveness of the 2 methods under study as a means to achieve a pregnancy have been ignored. In doing so, the investigators have ignored use-effectiveness reality.
Fertility AwarenessCycle Day VariabilityTiming and PredictionOvulation Timing
It is commonplace for gynecologists to refer to "midcycle" ovulation of women. This concept has often led to the routine diagnosis of ovulatory status on day 14 of what is expected to be a 28-day menstrual cycle. For example, the postcoital test in an infertile patient, or intercourse to achieve pregnancy in a normally fertile patient, is often timed around day 14 under the assumption that ovulation is occurring then. Advocates of natural family planning (NFP) have criticized the concept of "midcycle" ovulation, because their clinical experience suggests that the natural irregularity of menstrual-cycle length militates against ovulation's occurring with any great frequency on day 14.
This report analyzes the relationship of day 14 and the actual midcycle of the menstrual cycle to each other and to indirect hormonal parameters that more directly estimate the time of ovulation.
In this report, the ultrastructure of eM was studied by cryo-scanning electron microscopy (cryo-scan), which enabled us to observe the sample while it still contained water. … It was then placed in a specially made chamber which was part of the cryo-scanning electron microscope model JSM-50A (JEOL, Tokyo). The eM was examined after etching and coating with gold. A human cervical mucus specimen as observed by cryo-scan. The 3-dimensional netlike structure was characteristic (original magnification x 10,000).
General OB/GYNCultural PracticesTraditional Abstinence PracticesReproductive Behavior Surveys
This study was designed to test the assumption that women with regular menstrual cycles and premenstrual symptoms are ovulatory. 40 women aged 20-40 years were selected as probably ovulatory on the basis of their recent histories of regular menstrual cycles consistently accompanied by premenstrual molimina. Each subject recorded menses and (BBT) basal body temperature for 1-3 consecutive menstrual cycles during which luteal phase serum (P) progesterone concentrations were determined by radioimmunoassay. All subjects were rated ovulatory or anovulatory by each of several espoused P criteria which confirmed 39/40 subjects (98%) to be ovulatory by a 3 ng/ml criterion; 38/40 subjects (95%) by a 5 ng/ml criterion; and 36/40 (90%) by a 15 ng/ml criterion. Thus P measurements confirmed the clinical impression of ovulation in 90-98% of subjects depending on which P criterion was selected. BBT correlated well with P measurements in that 61/66 cycles (92%) displayed a biphasic BBT pattern 2/66 cycles (3%) displayed a monophasic BBT pattern and 3/66 cycles (5%) were uninterpretable. Only 1 subject was not ovulatory in either of 2 consecutive cycles by even the most liberal P criterion and both cycles were abnormally long and would have been suspected of being anovulatory on clinical grounds. We conclude that patients presenting with a history of regular menstrual cycles accompanied by premenstrual molimina are identifiable as ovulatory without the necessity of measuring luteal phase serum P concentrations. (Authors modified)
NFP (natural family planning) has replaced the term of rhythm method in the last decade as a designation for those methods of fertility regulation based on periodic abstinence. A graph presents the symptoms observable during the menstrual cycle and the ways in which these symptoms coincide with the fertile and infertile periods within the cycle. NFP counseling aims at teaching couples how to recognize the beginning and end of the fertile period within the menstrual cycle. Each of the following types of NFP are discussed 1) calendar or calculation method; 2) temperature method; 3) symptothermal methods; and 4) cervical mucus methods. All of these involve detection of the time of ovulation combined with abstinence during the fertile period of the cycle. The symptoms to recognize are taught with each method. Findings from 5 retrospective and 12 prospective studies on the effectiveness of NFP are tabulated. Current research and suggested areas for future research in the field of NFP are mentioned. In the last 20 years, NFP has been popularized through more popular-oriented educational programs. Governments have taken over funding of some NFP programs. Now that NFP effectiveness has been well established, motivation and counseling will be the most important elements in NFP education in the future.
Fertility AwarenessClient CounselingCalendar and BBTReproductive Physiology
This article describes the theory, methodology, and effectiveness of three natural rhythm by calendar, strict basal body temperature rhythm, and combination calendar-BBT rhythm. The author also appeals to family planning counselors to provide appropriate support and thorough teaching of the rhythmn method to those couples who choose to practice it and emphasizes that family planning counselors have the responsibility to present this method in a positive way when presenting alternatives to clients. For rhythm might be the method of choice for the woman whose cycles are on the longer, more regular side and for whom the abstinence during the fertile period would present no hardship to the couple's normal pattern of sexual relations. Contraceptive devices could be used as a supplementary measure during the fertile period. The necessity for the cooperation of both partners is, however, essential to the workability of the natural methods of family planning. High motivation, high knowledge of human reproductive physiology, and use of BBT all contribute to raising the effectiveness of the natural methods of family planning.
12 normal ovulatory women were studied during 17 menstrual cycles. The first day on which the women had increasing quantities of 0.1 ml or more clear cervical mucus (IQCCM) was closely related to the time of ovulation as monitored by basal body temperature and radioimmunoassay of serum-luteinizing hormone, follicle-stimulating hormone, estradiol, and progesterone. The results show that the time of ovulation can be predicted clinically without specialized tests by observing the day of onset of IQCCM.
St. Louis University Natural Family Planning Center. St. Louis. Missouri and Creighton University Natural Family Planning Education and Research Center, Omaha. Nebraska
The only way to be sure of avoiding pregnancy is for a couple to abstain from sexual intimacy during the fertile phase of the woman's cycle. Billings showed by reference to hormonal parameters that after competent instruction in the ovulation method women can identify the fertile phase of their cycle. If abstinence during the fertile phase is replaced by coitus combined with barrier methods, the pregnancy rate will be higher. The hormonal monitoring has revealed that the Peak Symptom as defined in the ovulation method is the most accurate biological marker of the time of ovulation. The cervical mucus pattern reflects the estrogen levels during follicular ripening from its commencement, and the Peak Symptom reflects a sharp cut-off effected by the elevation of the progesterone level at the time of ovulation. This means that once the mucus begins to be observed as a warning of the approach of ovulation, the woman needs to follow the changing characteristics on a daily basis in order to be certain that she recognizes ovulation.
The observation of the "Peak" mucus symptom in women using the ovulation method of natural family planning has been correlated with the estimated time of ovulation, as evaluated by indirect hormonal parameters. In 65 cycles of the 73 studied in 24 patients, there was hormonal confirmation of ovulation; in eight cycles, anovulation or luteal dysfunction was suspected. In the 65 normal cycles, 64 exhibited a Peak symptom. In those cycles, ovulation was estimated to occur from 3 days before to 3 days after the Peak symptom with a mean of 0.31 days before the Peak symptom. In 95.4% of these cycles, ovulation was estimated to occur from 2 days before to 2 days after the Peak symptom. The variation between cycles of the same patient ranged from 0 to 4 days with a mean of 1.8 days. The beginning of the mucus symptom preceded the estimated time of ovulation by an average of 5.9 days.
The only way to be sure of avoiding pregnancy is for a couple to abstain from sexual intimacy during the fertile phase of the woman's cycle. Billings showed by reference to hormonal parameters that after competent instruction in the ovulation method women can identify the fertile phase of their cycle. If abstinence during the fertile phase is replaced by coitus combined with barrier methods, the pregnancy rate will be higher. The hormonal monitoring has revealed that the Peak Symptom as defined in the ovulation method is the most accurate biological marker of the time of ovulation. The cervical mucus pattern reflects the estrogen levels during follicular ripening from its commencement, and the Peak Symptom reflects a sharp cut-off effected by the elevation of the progesterone level at the time of ovulation. This means that once the mucus begins to be observed as a warning of the approach of ovulation, the woman needs to follow the changing characteristics on a daily basis in order to be certain that she recognizes ovulation.
Fertility AwarenessComparison of NFP MethodsBillings MethodOvulation Detection
There are currently signs that more women are considering the natural family planning methods as an alternative to medical contraception. In response to this revival of interest, the World Health Organization is now conducting field work on 'natural' family planning methods in New Zealand, the Philippines, India, California, and Columbia and is also preparing a teaching package to be pilot tested in several countries. The natural methods of family planning are all based on the woman correctly ascertaining the pattern of her natural menstrual cycle and abstaining from sexual intercourse during the fertile time. In most women this means that there are 2 "safe periods" - at the beginning of the 28-day cycle until a few days before ovulation and at the end of the cycle from 3 or 4 days after ovulation has occurred. Originally, the "safe period" was taught by the calendar method, which involved a woman carefully plotting her menstrual cycle over a period of six months to a year and making calculations as to the shortest possible and longest possible cycle length, and thus the likely time of ovulation. A more accurate measure is to actually find out the point of ovulation by measuring basal body temperature. With this method the woman must take her temperature every morning immediately upon waking, before rising, smoking, eating or drinking. The Billings' ovulation method is the method now becoming increasingly popular. The method involves noticing the natural changes in the body over the whole menstrual cycle, particularly the quantity and quality of the cervical mucous. 1 new aid for pinpointing the exact time of ovulation is the Ovutime Fertility Detection System developed at Harvard University Medical School and the Massachusetts Institute of Technology. In the long-term, the rhythm method is unlikely to prove the answer to the problem of fertility regulation for the modern woman.
The new methods of natural family planning, i.e., the cervical mucus and symptothermal methods, provide couples with a form of birth control which is medically safe, totally and immediately reversible, and highly effective for stronly motivated couples. Furthermore, these methods cost nothing, have no side effects, and are completely drug and device-free. These methods are totally distinct from the traditional rhythm method which requires a woman to make daily quesses about her fertility status on the basis of her previously observed menstrual cycle patterns. In contrast, the new methods allow a woman to identify with certainty her current fertility status. These innovative methods are based on recent research which indicates that women are naturally safeguarded from pregnancy during 60-70% of their reproductive lives. Women can easily be taught to recognize physical symptoms which identify the naturally fertile and infertile perods of each cycle, i.e., 1) changes in the appearance and texture of cervical mucus, and 2) changes in basal body temperature. During the fertile periods, the cervical mucus is thin, slippery, stretchy, and clear. In this state the mucus helps the sperm cells travel up through the cervix and also provides an environment that keeps sperm cells viable for up to 5 days. During infertile periods, the cervical mucus is thick and gummy and acts as a barrier to prevent sperm from traveling through the cervix. During the fertile period the vaginal opening has a sensation of wetness and slipperiness, but during the infertile period, the vaginal opening has a sensation of dryness. Changes in basal body temperature can be used to identify the 2-week, naturally infertile, postovulatory phase of the menstrual cycle. Immediately after ovulation, a woman's temperature rises by .3-.4 of a degree. A temperature rise, sustained for 3 days, indicates that ovulation has occurred and that the egg is no longer viable. Women may use either or a combination of these symptoms to identify their fertile and infertile days. These methods require couples to abstain from intercourse during the fertile period which generally lasts for 7-12 days. The use of creams, jellies, and other chemicals during the fertile period to avoid the need to abstain is not recommended because these substances may mask changes in cervical mucus. According to a 2-year Canadian study couples who used these methods for spacing purposes only had a failure rate of 14.9 pregnancies/100 woman years; however, couples who definitely wanted no moe children, had a failure rate of only 1.1 pregnancies/100 woman years. Apparently, the strength of the motivation to prevent pregnancy accounted for the marked differences in the failure rates of these 2 groups.
Data from Malaysia on the reproductive goals of husbands and wives are analyzed to determine level of agreement, using new scale measures on preferences for number and sex of children as well as the conventional measure of desired number of children. The level of agreement between husband and wife varies considerably depending on the focus of analysis and the measure of agreement used. Overall aggregate agreement of men and women is high but lower for subgroups of the population, particularly among various ethnic groups. For marital partners, the agreement is much lower, especially on sex preferences. The level observed depends on whether the measure is identity of responses or an index of homogeneity which allows for couple concordance based on chance or common socialization factors. The views about the reproductive goals of one marital partner cannot with confidence be assumed to represent the views of the other.
The cervical canal mucus is important to human fertility since conception can only occur if sperm pass through the contents of the cervical canal to reach the ovum. The biophysical properties of the cervical mucus and their relation to sperm migration are, therefore, curcial. A variety of laboratory experimentation methods have been used 1) sperm migration measurements; 2) reheological studies; 3) cell countings; 4) crystallization studies; 5) 6) EPR; and 7) photoelectron spectroscopy. Cervical mucus is the end result of complicated biosynthetic processes occurring in the epithelial cells of the cervical mucosa; this biosynthesis is regulated by many factors. Type E, characteristic for estrogenic stimuli on mucus biosynthesis, and type G, for gestagenic stimulation, are the 2 main types of cervical secretions. The 2 types always occur together, in differing proportions. For example, at normal ovulation there is a 97:3 ratio of type E to type G; at normal corpus luteum, the ratio is 10:90. The string variety of type E seems to aid in conveying sperm from the vagina while the loaf variety is inactive. The very low viscosity of the string variety intermicellar fluid permits very rapid sperm swimming. Not much is known regarding cervical mucus pathology or therapy.
Summary Although sexual abstinence has probably been the single most important factor in restricting human fertility, Western researchers have tended to regard it as a phenomenon mostly found outside marriage. The research reported here was carried out amongst the Yoruba, a sub Saharan people, among whom it is more desirable in terms of social stability to practise female sexual abstinence mainly within marriage, rather than outside it. A similar situation is found widely in tropical Africa. Data are reported from five surveys carried out in 1973-75 in the Changing African Family and Nigerian Family Projects. Three types of marital abstinence are shown to have an post-natal abstinence (often wrongly described as a 'taboo'), terminal abstinence, and abstinence at other times. Female sexual abstinence is not paralleled by an equal practice of male abstinence, and the main reason for abstinence is to preserve long birth intervals and periods of lactation in a society prone to high rates of infant malnutrition and mortality. It is shown that the Index of Proportions Married (I ( m )) is only one of a number of fertility-weighted indices which can be employed to sub-divide the female reproductive span, and that a complete series of indices adding to unity can be constructed. The duration of lactation and abstinence are found to be related but, because abstinence is traditionally of longer duration, lactation amenorrhoea is of little importance in containing fertility. Married women spend less than half their reproductive lives in periods when sexual relations are possible and marital abstinence is between three and four times more important than delayed marriage in restricting fertility. The period of abstinence is shown to be changing and it is probable that it has never been of an agreed length; the concept of 'natural fertility' is examined in this light. The partial substitution of contraception for the abstinence period is analysed, and the possible effect on fertility considered.
The ovulation method of natural family planning is described in detail as taught in the ovulation method centers with an account of its development in Australia and the underlying philosophy. Hormonal studies supporting its scientific bases are given including recent work on the hormonal events of the menstrual cycle. The teaching of the method for the avoidance and achievement of pregnancy is outlined including special circumstances such as lactation premenopause stress situations abnormal vaginal discharges and formal oral contraceptive use. The failure rate of the ovulation method has been shown by a number of surveys as between that of the pill and the IUD. It is the fastest spreading method of natural family planning currently in use in 50 countries.
Research MethodologySocioeconomic Fertility AnalysisPostpartum Abstinence
Summary Many recent fertility studies in developing societies put forward the hypothesis of a negative relation between economic class and fertility. Data showing a positive relationship are frequently dismissed a priori as resulting from the reporting errors of illiterate women. This study draws on data from Indonesia's 1971 Census, a 1973 sample survey of fertility and mortality, and an intensive community study in Java, to argue that an observed positive relation between class and fertility is real, and is related to differences in patterns of marital disruption, postpartum abstinence, and fecundity. The positive relation may be reversed in the future as changes in these patterns, and the impact of the national family planning programme, affect the family structure of each class differently. Had the positive relation in this context been attributed offhand to reporting errors, these important socio-economic changes would have been misunderstood, and possibly ignored.
From January 1, 1968 to May 31, 1973, 100 patients received first kidney transplants from sibling donors. All recipients have been followed for at least two years and several as long as 7.5 years. One hundred per cent follow-up information is available. The absolute two-year patient survival is 85% and the absolute two-year kidney function survival is 76%. Patients with diabetes (especially males) have less success following transplantation than do patients without diabetes. When diabetic patients are excluded, older patients appear to do slightly less well than younger patients. Patients with phenotypically identical HL-A matches with the donor do better than patients without such matches. In the nondiabetic technically perfect transplant recepient, better than 90% long-term transplant function can be expectedwith no kidney losses after the first few months. In contrast, the less well-matched transplant demonstrated both an increased early rejection rate and a high rate of loss after the third to fifth year. Increasing doses of anti-lymphoblast globulin (ALG) had beneficial results in HL-A mismatched sibling transplants, but were slightly detrimental in phenotypically identical HL-A donor-recipient pairs because of an increased rate of infection. The results are compared with the results of transplants from other related donors and from cadavers performed during the same period.
Fertility AwarenessStatistical AnalysisMucus Pattern CharacterizationCycle Data Analysis
Nine healthy fertile women were studied during 29 menstrual cycles. A cervical mucus grading system, assessed by the patient and used in conjunction with basal body temperature, was correlated with plasma levels of luteinizing hormone (LH), oestradiol and plasma progesterone. The results show that a patient can be taught to predict the time of ovulation by observing the changes in the cervical mucus.
Fertility AwarenessClinical OutcomesEfficacy ComparisonPatient Series
A personal series of 600 private patients using natural family planning techniques is presented. The total failure rate was 4.7 pregnancies per 100 woman-years. The advantages of this method over conventional contraceptive techniques are stressed.
Psychological data was obtained from 1009 couples located in 5 countries who were practicing the temperature-rhythm method of birth control. In the U.S., survey instruments were distributed to 160 couples by mail with a 58% (92) return rate of completed questionnaires. The educational attainment of both men and women exceeded senior high school. Most wives were not gainfully employed, and 87% of the wives indicated that religious beliefs were considered important. The average couple had employed the rhythm method for 4 years and 9 months at the time of the survey. Independently, both husbands and wives completed a Byrne's Revised Repression-Sensitization scale, Rotter's I-E scale, and Attitude Toward Sex scale, a Reaction to the Temperature-Rhythm Method scale, and a sexual behavior inventory. Data indicated that the rhythm method was acceptable despite difficulties with periods of abstinence, with 84% regarding abstinence as relatively difficult or very diffiucult. Other results indicated that there was a relatively low response concordance between husbands and wives, and that couples who had pregnancies with the method or had abandoned the method had more liberal sexual attitudes than those who did not have pregnancies and continued the method.
Fertility AwarenessBillings Ovulation MethodField TrialsMucus and Temperature Indicators
The ovulation method of family planning relies on self-recognition of physiological changes occuring around time of ovulation rather than a calendar to enable a couple to avoid sexual intercourse during the fertile period. The most practical signs are elevated basal body temperature, changes in the amount and physicochemical properties of cervical mucus, and ovulation pain. The basal body temperature rises about .3 degrees C following ovulation. The problem with this method is that it is retrospective. The mucus symptoms, as described by Billings and associates in Melbourne, Australia, 1) a variable number of days with no vaginal discharge following menstrual bleeding; 2) onset of mucus symptoms characterized by increasing quantities of ''cloudy'' or ''sticky'' secretion; 3) a clear, slippery lubricative mucus having the characteristics of raw white of egg (spinnbarkeit), which is an immediate forwarning of ovulation; 4) a variable period of thick, opaque, diminished volume discharge followed by dry days. The clear ''peak symptom'' mucus lasts 1-2 days; in a study of 22 women followed for 27 cycles this symptom occurred .9 days +3 or -2 days before ovulation. The problem is that 2 of the 22 cycles reported in detail had ovulation 3 days after the peak symptom and 1 had ovulation 4 days after. Intercourse on the 4th day, therefore, would have had a significant risk of pregnancy. Weissman and associates collected data on 282 women on the Pacific island of Tonga who used the mucus symptoms alone to control conception. In the 2503 cycles there were 53 unplanned pregnancies, 25.4 per 100 woman-years using the Pearl formula. 50 resulted from the couples ''taking a chance,'' 2 misunderstood the method, 28 abandoned the method because they wanted more children, and 1 woman became pregnant even though she thought she understood the method. Field trials with groups who are more motivated than those in the Tongan trial are needed.
502 couples used the basal-body-temperature method of regulating births through 8294 cycles. The overall failure-rate in those confining coitus to the postovulatory phase of the menstrual cycle was 6·6 pregnancies per 100 women-years, while in those having coitus in the preovulatory and postovulatory phases it was 19·3 pregnancies per 100 women-years. The biological effectiveness of the method was greater than this, and was achieved by certain subgroups in the survey.
Physiologic effectiveness is the measure of protection against unwanted pregnancy afforded by a specific contraceptive method under ideal conditions ie, used consistently and according to instructions-without omissions, or errors of technique. Such ideal conditions are rarely present. Even when they are, it is not practicable to observe and verify them. Physiologic effectiveness, although not accessible to direct measurement, is by definition higher than the observed clinical effectiveness of the same method in the hands of the most …
Accurate timing of ovulation is especially necessary (1) in artificial insemination in order to avoid wastage of donor semen; (2) in cases where the husband is relatively infertile and it is necessary to conserve his semen. While many physicians rely upon the basal body temperature curve for timing ovulation, the interpretation of such curves is varied. Some physicians believe ovulation occurs prior to the lowest point in the temperature cycle, while others believe that ovulation occurs either at the low point or following the thermal shift. We have been disappointed in our ability to interpret the basal body temperature curve for accurate timing of ovulation, and have placed greater reliance upon concurrent phenomena, such as changes in the quantity and viscosity of cervical mucus and the cyclic changes observed in the vaginal smear. Although the relationship between the occurrence of a profuse, thin cervical mucus discharge and the optimal time of fertility in the human has been recognized for the past century, in our opinion this relationship requires further evaluation.
In his excellent review, "Cervical Cyclic variations and their clinical significance," Shettles quotes Robin who, in 1848, noted the viscous nature of human cervical secretions; and Smith who, in 1865, concluded that conception is most likely when the mucus contents of the cervix are in the most fluid condition. J. Marion Sims, who invented a vaginal speculum and first described the postcoital examination in 1868, observed that the test is positive for motile spermatozoa when the cervical mucus becomes clear and translucent, and about the consistency of the white of egg. Although these observations on human cervical mucus have been well documented, they have been almost disregarded by gynecologists. The significance of the cyclical outpouring of cervical mucus has been rediscovered in the past few years and has aroused great interest in students of sterility.
The optimal time of fertility in domestic animals is the period of heat or estrus. In 1925, Woodman and Hammond showed that during estrus, bovine cervical mucus is fluid and capable of being drawn out into threads, whereas in diestrus the mucus is thick. Seguy and Vimeux, and Seguy and Simonnet called attention to the optimal conditions of longevity of human spermatozoa in the fluid, glairy mucus of the cervix at midcycle. They postulated that these changes in cervical mucus were associated with ovulation and could be compared to the period of estrus in subprimate mammals. They correlated these changes with visual evidence of ovulation at laparotomy. ively, many women observe an increased sticky, mucoid discharge which is typical at midcycle and which is present over a period of days. On occasion this discharge is blood-tinged and may be compared to the distinct bloody mucoid discharge present in the domestic animal "in heat."
This mucus can be seen exuding from the cervix at midcycle and it may be aspirated from the endocervix and actually weighed, as reported by Viergiver and Pommerenke. Clift demonstrated certain rheologic properties of cervical mucus, especially flow elasticity and Spinnbarkeit. Flow elasticity, or elastic recoil of mucus, is measured by an instrument described by Blair. The use of the Blair capillary viscometer is a cumbersome method which we discontinued. We have had no experience with the new modification of the viscometer described by Clift, Glover, and Blair. Spinnbarkeit is easily tested, and we have found it to be a very practical objective method for determining viscosity of cervical mucus. In performing this test (Fig. 1), a vaginal speculum is inserted, exposing the cervix. A glass cannula is inserted into the endocervix and by means of gentle suction, a quantity of endocervical mucus is obtained. This mucus is blown onto a glass slide and a cover slip is placed on it. The mucus adheres to both the slide and the cover slip, and by withdrawing the cover slip, a thread of mucus is formed which can be measured in centimeters (Fig. 2). Usually, the cover slip is withdrawn several times, and the average length of the thread is ascertained. It is our purpose to show the relationship of Spinnbarkeit to other cyclic phenomena occurring during the menstrual cycle, such as basal body temperatures, vaginal smears, quantity of cervical mucus, and longevity of spermatozoa (Fig. 3).
Cervical mucus at midcycle is increased in amount, acellularity, water content, and fluidity. Furthermore, cervical mucus at this time is well supplied with carbohydrate and presumably amino acids. From a teleologic standpoint, we may conclude that because of these characteristics the sperm, on deposition in the vagina, find an environment propitious for their nutrition and migration through the cervical canal.
Reproductive EndocrinologyProgesterone PhysiologyBasal Body TemperatureHormonal Thermoregulation