Barbato M et al., 2026·Frontiers in Reproductive Health
Couple infertility is a common clinical condition that is too often treated with assisted reproductive techniques (ARTs) without a proper evaluation of both male and female factors. To improve the likelihood of natural conception, fertility awareness methods (FAMs) are widely used. We performed a multicenter prospective study enrolling couples with primary idiopathic infertility who were seeking natural conception. Participants were followed for 12 months using FAMs, and their outcomes were compared with those of couples who only used ARTs. The aim of our study was to evaluate the pregnancy rate after 12 months among couples with idiopathic infertility using FAMs compared with those who immediately pursued ARTs. We evaluated 41 couples in the FAM group and 56 couples in the ART group. In the FAM group, we reported a pregnancy rate (PR) of 51.22%. Among women aged <34 years, we reported a PR of 90.9%, while it decreased to 36.7% among women aged 35-39 years. In the ART group, 10 couples achieved pregnancy (PR 17.8%). Within this group, we reported a PR of 30% among women aged <34 years and 17.4% among women aged 35-39 years. After 12 months of unprotected intercourse without spontaneous conception in women younger than 35 years or after 6 months in women aged 35-39 years, couples should undergo a complete multidisciplinary diagnostic evaluation involving both the male and female partners. If a diagnosis of idiopathic infertility is established at the end of this process, couples (especially younger ones) may be advised to wait an additional 12 months while using FAMs, as no advantage has been observed with direct access to ARTs. They could then be referred to ART if a spontaneous pregnancy is not achieved during this period.
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 parameters were high: 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.
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.
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 evidence in four topical areas: (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.
Damba-Cunningham E et al., 2025·J Restorative Reprod Med·
Open Access
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.
Bernot G et al., 2025·European Journal of Obstetrics & Gynecology and Reproductive Biology
Fertility treatment pathways are complex and lengthy. The current prevalence of infertility makes it a public health issue. The involvement of general practitioners and the training of fertility instructors to provide therapeutic education have been suggested as ways of involving patients in the process and improving the therapeutic trajectory of these patients, who often have co-morbidities. To describe the activity of trained fertility instructors; to assess the interest of doctors in the fertility chart provided by women; and to describe the outcomes of their fertility care pathway. 66 French fertility instructors were interviewed in June 2024. The 15 general practitioners who had received additional training were also interviewed. The records of all couples who received fertility counselling and treatment between 1 January 2022 and 31 December 2023, the study cut-off date, were analysed. Doctors declared that the women had gained a clear understanding of their menstrual cycle, which was useful for diagnosis and treatment follow-up. The chart was particularly useful for diagnosing the causes of infertility and identifying when in the cycle to take medication. Only 4 of the 551 women were lost to follow-up. Of the remaining 547 women, 204 (37%) became pregnant. Of these, 75% had a live birth or an ongoing pregnancy at study cut-off. The involvement of fertility instructors and general practitioners improved the couple s ability to interact with doctors and to adhere to infertility treatment. The fertility chart provided by the women proved to be useful in the diagnosis and treatment process.
Pedersen ES et al., 2024·Paediatr Perinat Epidemiol·
Open Access
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 compare two different measures: (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. SHORT In FABM studies, the method-related pregnancy rate is biased too low, but the correct use pregnancy rate is unbiased.
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.
Background and
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.
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.
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. Study inclusion: 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.
Duane M et al., 2022·Front Med (Lausanne)·
Open Access
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.
Recent studies on fertility awareness among the reproductive population have reported the lack of accurate knowledge about fertility and assisted reproductive technologies. However, there has been little information regarding women trying to get pregnant at home. The aim of this study was to explore the prevalence of subclinical infertility among women trying to get pregnant at home, and to evaluate awareness regarding infertility and reasons for not visiting infertility clinics among women who use pregnancy-assist mobile applications to help them conceive. A total of 2084 Japanese women responded to this online survey. We selected 1541 women according to the study criteria. Based on the results of 61 questions, we evaluated knowledge regarding fertility, prevalence of subclinical infertility, and reasons for not visiting the clinic among the participants. Despite the desire to conceive, the participants had an apparent tendency to overestimate the age limit for childbearing. A total of 338 (21.9%) women answered that in general women aged > 45 years could get pregnant. Approximately 40% of the women had possible subclinical infertility and were unaware of the fact. Additionally, about 70% of the women considered themselves to have infertility problems. Women who were aware of the possibility of infertility hesitated to visit the clinic due to unfamiliarity with a gynecologist or clinic, and apprehensions about the gynecologic examination. In our study, some women required treatment for infertility. Nonetheless, they hesitated to visit an infertility clinic. Sexual health education, together with proper accessibility to gynecology clinics, are necessary to reduce involuntary childlessness.
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.
Lora J et al., 2022·Clin. Exp. Obstet. Gynecol.·
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.
Favaro C et al., 2021·J Womens Health (Larchmt)·
Open Access
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.
Turner JV, 2021·The journal of obstetrics and gynaecology research
Simplified contraceptive method-efficacy and/or typical-use effectiveness rates are commonly used for direct comparison of the various contraceptive methods. Use of such effectiveness rates in this manner is, however, problematic in relation to the fertility awareness methods (FAMs). The aim of this review is to critically examine current international representation of contraceptive effectiveness for the various FAMs in clinical use. This review also details important issues when appraising and interpreting studies on FAMs used for avoiding pregnancy. Current international literature regarding contraceptive effectiveness of FAMs was surveyed and appraised. This included World Health Organization and Centers for Disease Control (USA) resources, key clinical studies and recent systematic reviews. Chinese literature was also searched, since these data have not been reported in the English literature. Reliance on certain historical studies has led to the misrepresentation of contraceptive effectiveness of FAMs by perpetuation of inaccurate figures in clinical guidelines, the international literature and the public domain. Interpretation of published study results for FAMs is difficult due to variability in study methodology and other clinical trial quality issues. Recent systematic analyses have noted the considerable issues with study designs and limitations. Several non-English published studies using the Billings Ovulation Method have demonstrated that a broader review of the literature is required to better capture the data potentially available. A deeper understanding by clinicians and the public of the applicability of contraceptive effectiveness rates of the various FAMs is needed, instead of reliance on the inaccurate conglomerate figures that are widely presented.
Zhu TY et al., 2021·Journal of medical Internet research
As a daily point measurement, basal body temperature (BBT) might not be able to capture the temperature shift in the menstrual cycle because a single temperature measurement is present on the sliding scale of the circadian rhythm. Wrist skin temperature measured continuously during sleep has the potential to overcome this limitation. This study compares the diagnostic accuracy of these two temperatures for detecting ovulation and to investigate the correlation and agreement between these two temperatures in describing thermal changes in menstrual cycles. This prospective study included 193 cycles (170 ovulatory and 23 anovulatory) collected from 57 healthy women. Participants wore a wearable device (Ava Fertility Tracker bracelet 2.0) that continuously measured the wrist skin temperature during sleep. Daily BBT was measured orally and immediately upon waking up using a computerized fertility tracker with a digital thermometer (Lady-Comp). An at-home luteinizing hormone test was used as the reference standard for ovulation. The diagnostic accuracy of using at least one temperature shift detected by the two temperatures in detecting ovulation was evaluated. For ovulatory cycles, repeated measures correlation was used to examine the correlation between the two temperatures, and mixed effect models were used to determine the agreement between the two temperature curves at different menstrual phases. Wrist skin temperature was more sensitive than BBT (sensitivity 0.62 vs 0.23; P<.001) and had a higher true-positive rate (54.9% vs 20.2%) for detecting ovulation; however, it also had a higher false-positive rate (8.8% vs 3.6%), resulting in lower specificity (0.26 vs 0.70; P=.002). The probability that ovulation occurred when at least one temperature shift was detected was 86.2% for wrist skin temperature and 84.8% for BBT. Both temperatures had low negative predictive values (8.8% for wrist skin temperature and 10.9% for BBT). Significant positive correlation between the two temperatures was only found in the follicular phase (rmcorr correlation coefficient=0.294; P=.001). Both temperatures increased during the postovulatory phase with a greater increase in the wrist skin temperature (range of increase: 0.50 °C vs 0.20 °C). During the menstrual phase, the wrist skin temperature exhibited a greater and more rapid decrease (from 36.13 °C to 35.80 °C) than BBT (from 36.31 °C to 36.27 °C). During the preovulatory phase, there were minimal changes in both temperatures and small variations in the estimated daily difference between the two temperatures, indicating an agreement between the two curves. For women interested in maximizing the chances of pregnancy, wrist skin temperature continuously measured during sleep is more sensitive than BBT for detecting ovulation. The difference in the diagnostic accuracy of these methods was likely attributed to the greater temperature increase in the postovulatory phase and greater temperature decrease during the menstrual phase for the wrist skin temperatures.
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 from three cohorts of women: '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 cycle were examined as follows: 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. Data Sources: 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. Data Extraction: 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.
Costa Figueiredo M et al., 2021·JAMIA Open·
Open Access
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 data from three sources: the content of app store pages, app features, and user reviews. Findings: 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·
Open Access
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.
Pearson JT et al., 2020·J Womens Health (Larchmt)·
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).
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 use of fertility indicators: 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 with a history of subfertility: 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.
Ali R et al., 2020·Reprod Biomed Online·
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.
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."
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 main themes were identified: 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.
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.
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.
Maijala A et al., 2019·BMC Womens Health·
Open Access
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.
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 …
Bouchard TP et al., 2019·Front Public Health·
Open Access
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.
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.
Jennings V et al., 2019·Eur J Contracept Reprod Health Care·
Open Access
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.
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.
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 meeting had four (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 identified as high priority: (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 woman-years varied widely: 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.
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.
Murcia Lora JM et al., 2018·Journal of Labor and Childbirth
Observational Study. The objective of the study was to contrast the evolution and progression of the viscoelasticity of the cervical secretion in the fertile window of ovulatory menstrual cycles compared with a software tool. 12 records obtained by vaginal discharge of the cervical secretion (VDRS) analyzed by means of the key filament of the Creighton Model Fertility (CrMS), and a computer software tool applied to the recognition of viscoelasticity. Peak day of cervical discharge “P” established as the estimated day of ovulation (EDO). The clinical window in this article was established as (mucus-mucus: CrMS/filancia) by retrospective evaluation of the aforementioned scale taking into account the previous 6 days at peak day: P (-6). The calculated fertile window was defined as (Soft-CrMS/filancia), which was obtained from an applied computer tool, (Soft-CrMS/filancia) was calculated without contributing EDO to the integration of the computer calculation. The verification and justification of the calculation of the fertile window was based on the analysis of the progression of the elasticity of the cervical secretion. The methodology used consisted of comparing the two fertile windows with EDO. To check the evolution in the characterization of the viscoelasticity parameter of cervical secretion, the last day of maximum fertility was established, with the letter “P” of peak day, according to the rules of recognition of the Peak day of CrMS. The fertile window was detected in 100% of the cases with both methods. A correlation coefficient of 0.71 was obtained, between the clinical fertile window detected by means of the parameter of viscoelasticity of the cervical secretion, and the prediction of viscoelasticity by means of a software computer tool. Analysis of the interval using SFW (Soft-CrMS / filance) showed a normal distribution with a mean of 5.08 (SD of + - 2.87). In this context, it is evident that as soon as the cervical mucus stretches more, and the elasticity increases, both the days before the peak day and the days after the vescoelasticity parameter it was possible to record it. Within another of the biophysical parameters, the characteristics of the last days of maximum fertility were taken into account through the concept of: Last Max Spinbarkheit (LMS) & Transparency by “K” of CrMS LMS The assessment of viscoelasticity using Spinbarkheit/ streching algoritm allowed in this pilot study to detect the fertile window, and to describe the evolutionary pattern of cervical discharge throughout the fertile window. The determination of the filancia and combination of transparency parameters may in conjunction detect by a clinical method to identify and describe the fertile window. The assessment of viscoelasticity using Spinbarkheit allowed in this pilot series to detect the fertile window in 100% of the cases, and it was possible to describe the evolutionary pattern of cervical secretion throughout the menstrual cycle. The fertile window interval can be observed with a 75% accuracy rate by viscoelasticity. The prediction in the progression of the elasticity pattern of the cervical secretion allows detecting the typical evolution of the cervical secretion in 70% around the peak day of ovulation. The determination of the filancia is a parameter that in conjunction with a clinical method can help to identify and characterize the fertile window.
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 methods were also examined: 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. National Clinical Trial Code: NCT01577147. Registry website: www.clinicaltrials.gov .
Bouchard TP et al., 2018·Front Med (Lausanne)·
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.
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.
Porucznik CA et al., 2017·Front Med (Lausanne)·
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.
Su HW et al., 2017·Bioengineering & translational medicine
The ability to identify the precise time of ovulation is important for women who want to plan conception or practice contraception. Here, we review the current literature on various methods for detecting ovulation including a review of point-of-care device technology. We incorporate an examination of methods to detect ovulation that have been developed and practiced for decades and analyze the indications and limitations of each-transvaginal ultrasonography, urinary luteinizing hormone detection, serum progesterone and urinary pregnanediol 3-glucuronide detection, urinary follicular stimulating hormone detection, basal body temperature monitoring, and cervical mucus and salivary ferning analysis. Some point-of-care ovulation detection devices have been developed and commercialized based on these methods, however previous research was limited by small sample size and an inconsistent standard reference to true ovulation.
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...
Danis PG et al., 2017·Front Med (Lausanne)·
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.
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.
Frank-Herrmann P et al., 2017·Arch Gynecol Obstet·
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 prior to Sensiplan training: 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.
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. CLINICAL 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 menstrual cycle: 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. Lay 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.
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 recruited from three centres: 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.
Fehring RJ et al., 2015·J Midwifery Womens Health·
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.
to study the results in patients undergoing infertility treatment with a focus on restorative medicine (NaProTechnology) at a department of obstetrics and gynecology. Methodology: retrospective cohort study conducted by the gynecology and obstetrics department at Universidad de los Andes (Santiago, Chile) in infertility patients from a suburban area of Santiago de Chile, who received treatment between 2006 and 2014. All couples received instructions on how to recognize their fertility period according to a local teaching model based on the Creighton Model FertilityCare System. They also received medical treatment to induce ovulation and/or widen their fertile period, or surgical treatment. The main outcome was the number of pregnancies. 131 patients received instructions. The mean age was 33.6 years. Seventyeight patients (59.5%) consulted due to primary infertility; 53 (40.5%) due to secondary infertility. The duration of group infertility was 4.1 years. The mean use of the method was 12.6 months (median, 9 months). The infertility causes identified included anovulation (50.4%), tubo-peritoneal factors (18.3%), endometriosis (14.5%), uterine factors (9.2%), cervical factors (8.4%) and masculine factors (19.1%). There were 33 pregnancies (25.2 global). The crude proportion of pregnancies at 24 months was 22.9% and the proportion adjusted by the life table at 24 months was 40 per 100 couples. the focus on restorative medicine is effective to achieve pregnancy but it requires a long-term longitudinal treatment. Early discontinuation of fertility charting affects the efficacy of this focus. More research is warranted to optimize medical treatment.
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.
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.
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.
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. There are two functions: (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 women randomised: 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.
Leiva R et al., 2014·J Am Board Fam Med·
Open Access
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.
Fehring RJ et al., 2014·J Obstet Gynecol Neonatal Nurs·
Open Access
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.
Porucznik CA et al., 2014·BMC Womens Health·
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). NURSING 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.
L’auto-osservazione e il follow-up grafico del ciclo mestruale in caso di presunta sterilita, aiutano a diagnosticare e trattare certe alterazioni ginecologiche, al fine di attuare il rapporto sessuale finalizzato ad ottimizzare concepimento. Attraverso queste procedure naturali (naprotecnologia), prive di aspetti negativi da un punto di vista etico, possiamo ottenere tassi di natalita che sono paragonabili, o addirittura superiori, a quelle ottenute con trattamenti invasivi. ---------- Self-observation and the graphic follow-up of the menstrual cycle in cases of supposed infertility, help to diagnose and treat certain gynaecological alterations in order to carry out the sexual intercourse focused on optimising conception. Through these natural procedures (Naprotechnology), with no ethical drawbacks, we can obtain birth rates that are comparable, or even higher, to those obtained with invasive treatments.
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).
Clinical 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.
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.
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.
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.
Fehring RJ et al., 2012·Contraception·
Open Access
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.
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.
Uchimura NS et al., 2011·Rev Gaucha Enferm·
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.
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 percentiles: 24 and 35 days, respectively), a mean follicular phase of 14.8 ± 3.1 days (n = 107; 5th and 95th percentiles: 11 and 21 days) and a mean luteal phase length of 13.3 ± 1.5 days (n = 106; 5th and 95th percentiles: 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.
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·
Open Access
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. Outcomes: 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.
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.
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.
Bedford JL 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 repeating the analysis using: (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.
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.
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.
Clinical 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.
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.
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.
Fehring RJ et al., 2007·J Obstet Gynecol Neonatal Nurs·
Open Access
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.
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 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.
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.
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.
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.
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
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.
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.
Barron ML et al., 2005·MCN Am J Matern Child Nurs·
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.
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.
Grimes DA et al., 2004·Cochrane Database Syst Rev·
"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.
Selection Criteria: 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. MAIN 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.
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.
Fehring RJ et al., 2004·Contraception·
Open Access
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.
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY·
NaProTECHNOLOGY utilizes a defined panel of cycle-phase-specific biomarkers — including targeted progesterone, estradiol, LH, FSH, and prolactin drawn at CrMS-standardized cycle days — to characterize the hormonal profile underlying each patient's reproductive dysfunction. This biomarker summary consolidates reference ranges, collection timing rules, and clinical interpretation frameworks that govern diagnosis and treatment decisions across infertility, endometriosis, recurrent pregnancy loss, and cycle irregularity.
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.
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY·
NaProTECHNOLOGY uses the Peak Day of the Creighton Model chart — the last day of the most fertile-type cervical mucus — as the reference point for dating conception, providing a biologically grounded alternative to last menstrual period dating that remains accurate across irregular cycles. Precise cycle-based dating improves the clinical interpretation of early pregnancy hormone levels, ultrasound findings, and obstetric gestational age assignments, reducing unnecessary interventions triggered by apparent growth discordance.
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·
Adaptations of CrMS instruction for physiologically distinct reproductive states — including breastfeeding, post-hormonal contraceptive use, long or irregular cycles, and premenopause — are described with specific observational guidance for each context. These special protocols extend the clinical reach of the CrMS to all phases of a woman's reproductive life and ensure that charting remains interpretable even when cycle dynamics are atypical.
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY·
Preconceptional optimization using CrMS cycle data establishes hormonal baselines, identifies correctable pathologies, and guides targeted supplementation before conception is attempted. Systematic preconceptional evaluation reduces early pregnancy loss and improves obstetric outcomes by ensuring the endocrine environment supports implantation and early embryonic development.
Stanford JB, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY·
Methodologically rigorous effectiveness data for the CrMS are presented, including method-effectiveness and use-effectiveness rates for pregnancy avoidance drawn from prospective cohort studies, demonstrating rates comparable to or exceeding hormonal contraception. Standardized outcome measurement is necessary to establish the CrMS's scientific credibility and to provide practitioners and patients with accurate, evidence-based counseling on system performance.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Behre HM et al., 2000·Human reproduction (Oxford, England)
The timing of sexual intercourse in relation to ovulation strongly influences the chance of conception. Daily serum LH measurements or transvaginal ultrasonography are not practical to determine ovulation in consecutive cycles for an individual. A prospective study was initiated to test the home use performance of the ClearPlan Fertility Monitor (CPFM) in ovulation prediction compared with transvaginal ultrasonography and serum hormone measurements. A total of 53 women aged 18-39 years with a normal uterus and at least one ovary, cycle length between 21-42 days and not using medication which interferes with ovarian function contributed 150 cycles for analysis. One cycle was anovulatory and no LH surge, indicating peak fertility, was detected by the monitor. Of the remaining 149 cycles, 135 (90.6%) had a monitor LH surge and ultrasonographically confirmed ovulation. Ovulation was detected in 91.1% of cycles during the 2 days of CPFM peak fertility. Ovulation was observed in 51.1% of cycles 1 day and in 43.2% of cycles 2 days after the surge in serum LH. Ovulation never occurred before CPFM peak fertility or the serum LH surge day. CPFM can help women who desire pregnancy to time intercourse. It may also have potential as a diagnostic aid and for monitoring the treatment of infertility.
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)
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.
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.
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.
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 couples: 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 reproductive categories: 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.
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. MATERIAL AND 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, the criteria are: a calculation on the length of the previous twelve cycles and the first sign of mucus at either the vulva or the cervix. Indicators of the end of this phase are: 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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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. . .
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.
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.
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 during the fertile phase: 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)
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.
Hilgers TW et al., 1992·The Journal of reproductive medicine
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%).
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.
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.
Users of natural family planning (NFP) methods of birth control should be aware of the medications that can effect their ability to read their fertility signs. Antihistamines and decongestants are the most common medications that can affect the mucus signs. Antihistamines tend to dry up the mucus while decongestants tend to liquify mucus. Some anti-depressants sometime act like antihistamines while steroids like cortisone do not change the signs but can lengthen the cycle. Although with cortisone it seems to depend on when in the cycle it is administered. Finally, while antibiotics do not effect the cycle they can cause a secondary yeast infection. These yeast infections can in turn make reading difficult. The solution is to eat yogurt, take lactobacillus tablets or drink acidophilus milk before, during and after taking antibiotics.
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 the ovulatory cycle: 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.
Fehring RJ, 1990·J Obstet Gynecol Neonatal Nurs·
Open Access
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.
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. Major findings include: 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.
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.
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%.
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 by study respondents were: 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 of information about NFP were: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 study was concerned with: 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 stages: 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 factors: 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.
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)
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 phases: 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.
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 requires certain conditions: 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.
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. Disadvantages include: 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.
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 practice of the method include: 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.
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. The terms included are: 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.
Pip: 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 centers are involved: 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, were found to be as follows: 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. These includes the following: 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.
This review of natural family planning (NFP) focuses on the following: 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)
Past practices of Natural Family Planning (NFP) have included such techniques as: 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.
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.
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.
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 on the following criteria: 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 issues remain unresolved: 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.
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
I read with interest the recent article by Wade and associates, "A randomized prospective study of the use-effectiveness of 2 methods of natural family planning: 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.
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 and explained in detail: 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.
This article describes the theory, methodology, and effectiveness of three natural methods of family planning: 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
Pip: 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.
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.
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.
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.
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.
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, are: 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.
Also filed here
Cycle Across the Lifespan · Cycle and General Health
Bouchard TP et al., 2026·Journal of ovarian research·
Open Access
Reproductive hormones of the fertile window are often referenced to women in regular cycles, but this may not be representative of the hormonal profiles of women in different circumstances like polycystic ovarian syndrome, the postpartum period, and the perimenopause transition. This observational cohort study sought to identify the variability in the reproductive hormones in various clinical circumstances and to establish potential thresholds for each category based on hormone measurements with the Mira urinary hormone monitor. A total of 57 women (ages 22-51) in various circumstances (regular cycles, polycystic ovarian syndrome, postpartum and perimenopause) tracked Mira urine hormone measurements (estrone-3-glucuronide, luteinizing hormone, pregnanediol glucuronide), contributing 444 cycles of data. Using additive mixed models, hormone values were stratified by the four different reproductive categories. The perimenopause and polycystic ovarian syndrome groups demonstrated relative hypoestrogenic states, while the perimenopause group showed low luteal pregnanediol glucuronide and the polycystic ovarian syndrome/polyendocrine metabolic ovarian syndrome (PCOS/PMOS) group showed high luteal pregnanediol glucuronide. The perimenopause group had significantly higher luteinizing hormone values throughout the whole cycle. The fertile window hormone thresholds vary depending on a woman's specific reproductive category. Women in different circumstances should not necessarily use the same hormonal thresholds for the fertile window and ovulation. A larger dataset with ultrasound correlation to ovulation is required to delineate the fertile window with more precision. Hormone differences across the menstrual cycle could be used for targeted treatments in polycystic ovarian syndrome and perimenopause women.
Duane M et al., 2025·J Restorative Reprod Med·
Open Access
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.
Bouchard TP et al., 2025·Preprints.org·
Open Access
Background/Objectives: 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.
Cycle Across the Lifespan · Cycle and General Health
Background Reproductive hormones of the fertile window are often referenced to women in regular cycles, but this may not be representative of the hormonal profiles of women in different circumstances like polycystic ovarian syndrome, the postpartum period, and the perimenopause transition. This observational cohort study sought to identify the variability in the hormones of the fertile window in various reproductive categories and to establish potential thresholds for each category based on hormone measurements with the Mira urinary hormone monitor. Results A total of 57 women (ages 22–51) in various circumstances (regular cycles, polycystic ovarian syndrome, postpartum and perimenopause) tracked Mira urine hormone measurements (estrone-3-glucuronide, luteinizing hormone, pregnanediol glucuronide), contributing 444 cycles of data. Using additive mixed models, hormone values were stratified by the four different reproductive categories. The perimenopause and polycystic ovararian syndrome groups demonstrated relative hypoestrogenic states, while the perimenopause group showed low luteal pregnanediol glucuronide and the polycystic ovarian syndrome group showed high luteal pregnanediol glucuronide. The perimenopause group had higher luteinizing hormone values throughout the whole cycle. Conclusion The fertile window hormone thresholds vary depending on a woman’s specific reproductive category. Women in different circumstances should not necessarily use the same hormonal thresholds for the fertile window and ovulation. A larger dataset with ultrasound correlation to ovulation is required to delineate the fertile window with more precision. Hormone differences across the menstrual cycle could be used for targeted treatments in polycystic ovarian syndrome and perimenopause women.
Meyers M et al., 2023·Medicina (Kaunas)·
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.
Natural Procreative Technology (NaProTechnology) is a system of management of infertility and other reproductive health issues which requires the application of a woman’s observation and record of key events throughout her menstrual cycle. The study assessed the knowledge, awareness, and perception of NaProTechnology as well as the effect of an educational intervention among pharmacy undergraduate students at University of Nigeria, Nsukka. It was a cross-sectional, questionnaire-based study. The ethical approval was obtained from the research ethics committee of the Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka. At baseline, the knowledge, awareness and perception of the students were assessed. Followed by the administration of an educational video on NaProTechnology. Then a post intervention survey was done to assess the effect of the educational intervention. Key finding: s
There were 410 and 350 students in the preand post-intervention surveys respectively with relatively equal number of males and females. Majority were between 18 and 29 years old. Less than 5% were married while the highest proportion of the respondents were from 300 level The knowledge, awareness, and positive perception of NaProTechnology among the pharmacy students prior to intervention were poor but improved markedly post intervention (P < 0.001).
A video intervention was effective in improving the short-term knowledge, awareness and positive perception of NaProTechnology among pharmacy students. Key message: s
What is already known on this topic?
Natural Procreative Technology (NaProTechnology) is a system of management of infertility based on the observation and record of fertility biomarkers by a woman. What this study add: s?
The level of knowledge, awareness, and positive perception of NaProTechnology among the pharmacy undergraduates students were poor prior to a video intervention but improved markedly afterwards
How this study might affect research, practice or policy?
This study would lead to the public health system approach of informing, educating and communicating NaProTechnology to pharmacy students to achieve long-term effects by using well-designed courses and curriculum implementation.
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, three revisions were made: (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.
Jankowska K et al., 2022·Life (Basel)·
Open Access
Biochemical markers of spermatogenesis and fertility assessment are important in the practical management of infertile males and the determination of an individual’s prognosis. We performed an analysis on 100 males with a male infertility factor. The following study inclusion parameters were analyzed: seminogram, FSH, LH, testosterone, estradiol, prolactin, TSH, and inhibin B concentrations. The patients were subsequently treated by reproductive endocrinologists in accordance with AUA/ASRM and EAU guidelines. The reproductive status was evaluated over a period of 3 years. We found a strong correlation of sperm count with inhibin B (r = 0.74, p < 0.001) and FSH concentration levels (r = −0.46, p < 0.001). Among 95 patients at follow-up, pregnancies occurred for 59 of their partners (48 spontaneous, 5 after IVF−ET, and 6 after IUI). Thirty-six patients remained childless despite the therapy. Sperm count and inhibin B level were the best predictors of natural fertilization (ROC 0.86 and 0.84; cut-off: 2.7 mln/mL and 45 pg/mL). Although inhibin B and FSH can be used to evaluate spermatogenesis and fertility, the initial sperm concentration appeared to be the best predictor of success. Pregnancy was achieved in a surprisingly large proportion of patients with a very low concentration of inhibin B and a low initial sperm count. It is noteworthy that 81% of the pregnancies were achieved without medically assisted reproduction.
Restorative Care and Assisted Reproduction · Outcome Comparisons
La progresiva medicalización de la infertilidad en las últimas tres décadas se corresponde con una creciente difusión de las Tecnologías de Reproducción Asistida (TRA), que han dejado en la sombra, casi por completo, otros enfoques más fisiológicos del tratamiento de la infertilidad, que tienen menos riesgos, son más económicos y, a la vez, igualmente efectivos. Este trabajo presenta un enfoque sistemático e integrado: la NaProTecnología (NPT), que tiene como objetivo optimizar las condiciones fisiológicas en cada ciclo menstrual, para permitir, de esta forma, una concepción por métodos naturales. Este método se postula como una mejor solución para el tratamiento de la infertilidad, desde un punto de vista que no sólo es más ético, sino que, además, es compatible con otros puntos de vistas religiosos, médicos, sociales, legales y ambientales. Los gobiernos deberían promover y financiar la NPT y, al mismo tiempo, las sociedades médicas y científicas deberían diseñar estudios para comparar de una manera justa la tasa de éxito, los costos y las complicaciones de la NPT en contraposición al método TRA tradicional.
Stanford JB et al., 2021·BMC Pregnancy Childbirth·
Open Access
Restorative reproductive medicine (RRM) seeks to identify and correct underlying causes and factors contributing to infertility and reproductive dysfunction. Many components of RRM are highly suitable for primary care practice. We studied the outcomes amongst couples who received restorative reproductive medicine treatment for infertility in a primary care setting. Two family physicians in Massachusetts trained in a systematic approach to RRM (natural procreative technology, or NaProTechnology) treated couples with infertility. We retrospectively reviewed the characteristics, diagnoses, treatments, and outcomes for all couples treated during the years 1989 to 2014. We compared pregnancy and live birth by clinical characteristics using Kaplan-Meier analysis. We employed the Fleming-Harrington weighted Renyi test or the logrank test to compare the cumulative proportion with pregnancy or with live birth. Among 370 couples beginning treatment for infertility, the mean age was 34.8 years, the mean prior time trying to conceive was 2.7 years, and 27% had a prior live birth. The mean number of diagnoses per couple was 4.9. Treatment components included fertility tracking with the Creighton Model FertilityCare System (80%); medications to enhance cervical mucus production (81%), to stimulate ovulation (62%), or to support the luteal phase (75%); and referral to female laparoscopy by a surgeon specializing in endometriosis (46%). The cumulative live birth rate at 2 years was 29% overall; this was significantly higher for women under age 35 (34%), and for women with body mass index < 25 (40%). There were 2 sets of twins and no higher-order multiple gestations. Of the 63 births with data available, 58 (92%) occurred at term. Family physicians can provide a RRM approach for infertility to identify underlying causes and promote healthy term live births. Younger women and women with body mass index < 25 are more likely to have a live birth.
To determine whether serum anti-Müllerian hormone (AMH) level is a predictor of clinical pregnancy in women trying to achieve a natural conception. Eleven studies (4,388 women) were ultimately included in this meta-analysis. The AUC and Cochran Q indices were 0.5932 and 0.5702, respectively. Serum AMH levels have poor predictive value for natural pregnancy. Our findings suggest that low serum AMH levels are not associated with reduced fertility.
Horodenchuk Z et al., 2020·Kwartalnik Naukowy Fides et Ratio
To assess the outcomes of treatment the couples with infertility or recurrent miscarriage with restorative reproductive approach and to identify predictors of success. It was a retrospective study of 282 married couples, who were included in the program in 2 outpatient gynaecological centers in May 2010 - December 2014. The couples were observed to the end of pregnancy (or pregnancies) or withdrawal from the program. All the couples were taught to track the cycle with the Creighton Model FertilityCare System or the sympto-thermal method, and almost all received additional medical treatment. The main outcome was live birth, the secondary outcomes included conceptions, unsuccessful pregnancies, low birth weight and prematurity. In life-table analysis, the adjusted cumulative proportion of first conceptions for those completing up to 24 months of NPT treatment was 77.7% (crude proportion 47.9%). The adjusted cumulative proportion of live births was 73.6% (117 births, crude proportion 41.5%). Mean time to achieving pregnancy was 8 months. All the births except one were singleton. There were only 3 preterm births. The favorable predictors of live birth were younger age, shorter time of trying for baby, good compliance, pregnancy in history. The unfavorable were hyperprolactinemia, uterine fibroids, endometriosis, male factor. The outcomes of restorative reproductive treatment the couples with infertility or recurrent miscarriage in Ukraine were comparable to those in Ireland and Canada.
Cycle Across the Lifespan · Cycle and General Health
Grieger JA et al., 2020·Journal of medical Internet research
There is increasing information characterizing menstrual cycle length in women, but less information is available on the potential differences across lifestyle variables. This study aimed to describe differences in menstrual cycle length, variability, and menstrual phase across women of different ages and BMI among a global cohort of Flo app users. We have also reported on demographic and lifestyle characteristics across median cycle lengths. The analysis was run based on the aggregated anonymized dataset from a menstrual cycle tracker and ovulation calendar that covers all phases of the reproductive cycle. Self-reported information is documented, including demographics, menstrual flow and cycle length, ovulation information, and reproductive health and diseases. Data from women aged ≥18 years and who had logged at least three cycles (ie, 2 completed cycles and 1 current cycle) in the Flo app were included (1,579,819 women). Of the 1.5 million users, approximately half (638,683/1,579,819, 40.42%) were aged between 18 and 24 years. Just over half of those reporting BMIs were in the normal range (18.5-24.9 kg/m2; 202,420/356,598, 56.76%) and one-third were overweight or obese (>25 kg/m2; 120,983/356,598, 33.93%). A total of 16.32% (257,889/1,579,819) of women had a 28-day median cycle length. There was a higher percentage of women aged ≥40 years who had a 27-day median cycle length than those aged between 18 and 24 years (22,294/120,612, 18.48% vs 60,870/637,601, 9.55%), but a lower percentage with a 29-day median cycle length (10,572/120,612, 8.77% vs 79,626/637,601, 12.49%). There were a higher number of cycles with short luteal phases in younger women, whereas women aged ≥40 years had a higher number of cycles with longer luteal phases. Median menstrual cycle length and the length of the follicular and luteal phases were not remarkably different with increasing BMI, except for the heaviest women at a BMI of ≥50 kg/m2. On a global scale, we have provided extensive evidence on the characteristics of women and their menstrual cycle length and patterns across different age and BMI groups. This information is necessary to support updates of current clinical guidelines around menstrual cycle length and patterns for clinical use in fertility programs.
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.
Goodale BM et al., 2019·J Med Internet Res·
Open Access
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.
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.
Abdulla SH et al., 2018·Front Public Health·
Open Access
Explore potential relationships between preovulatory, periovulatory, and luteal-phase characteristics in normally cycling women.
Observational study.
Eight European natural family planning clinics. Patient(s): Ninety-nine women contributing 266 menstrual cycles. Intervention(s): The participants collected first morning urine samples that were analyzed for estrone-3 glucuronide (E1G), pregnanediol-3alpha-glucuronide (PDG), follicle stimulating hormone (FSH), and luteinizing hormone (LH). The participants underwent serial ovarian ultrasound examinations. Main Outcome Measure(s): Four outcome measures were analyzed: short luteal phase, low mid-luteal phase PDG level (mPDG), normal then low luteal PDG level, low then normal luteal PDG level. A long preovulatory phase was a predictor of short luteal phase, with or without adjustment for other variables. A high periovulatory PDG level was a predictor for short luteal phase as well as normal then low luteal PDG level. A low periovulatory PDG level predicted low mPDG and low then normal luteal PDG level, with or without adjustment for other variables. A small maximum follicle predicted normal then low luteal PDG level, with or without adjustment for other variables. The relationship between small maximum follicle size and short luteal phase or small maximum follicle size and low mPDG was no longer present when the regression was adjusted for certain characteristics. A younger age at menarche and a high body mass index were both predictors of low mPDG. Luteal phase abnormalities exist over a spectrum where some ovulation disorders may exist as deviations from the normal ovulatory process.This study confirms the negative impact of a small follicle size on the quality of the luteal phase. The occurrence of normal then low luteal PDG level is confirmed as a potential sign of luteal phase abnormality.
Comparative Studies · Contraception Versus Fertility Awareness
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. …
Despite lack of evidence of their utility, biomarkers of ovarian reserve are being promoted as potential markers of reproductive potential. To determine the associations between biomarkers of ovarian reserve and reproductive potential among women of late reproductive age. DESIGN, SETTING, Prospective time-to-pregnancy cohort study (2008 to date of last follow-up in March 2016) of women (N = 981) aged 30 to 44 years without a history of infertility who had been trying to conceive for 3 months or less, recruited from the community in the Raleigh-Durham, North Carolina, area. Exposures: Early-follicular-phase serum level of antimüllerian hormone (AMH), follicle-stimulating hormone (FSH), and inhibin B and urinary level of FSH. The primary outcomes were the cumulative probability of conception by 6 and 12 cycles of attempt and relative fecundability (probability of conception in a given menstrual cycle). Conception was defined as a positive pregnancy test result. A total of 750 women (mean age, 33.3 [SD, 3.2] years; 77% white; 36% overweight or obese) provided a blood and urine sample and were included in the analysis. After adjusting for age, body mass index, race, current smoking status, and recent hormonal contraceptive use, women with low AMH values (<0.7 ng/mL [n = 84]) did not have a significantly different predicted probability of conceiving by 6 cycles of attempt (65%; 95% CI, 50%-75%) compared with women (n = 579) with normal values (62%; 95% CI, 57%-66%) or by 12 cycles of attempt (84% [95% CI, 70%-91%] vs 75% [95% CI, 70%-79%], respectively). Women with high serum FSH values (>10 mIU/mL [n = 83]) did not have a significantly different predicted probability of conceiving after 6 cycles of attempt (63%; 95% CI, 50%-73%) compared with women (n = 654) with normal values (62%; 95% CI, 57%-66%) or after 12 cycles of attempt (82% [95% CI, 70%-89%] vs 75% [95% CI, 70%-78%], respectively). Women with high urinary FSH values (>11.5 mIU/mg creatinine [n = 69]) did not have a significantly different predicted probability of conceiving after 6 cycles of attempt (61%; 95% CI, 46%-74%) compared with women (n = 660) with normal values (62%; 95% CI, 58%-66%) or after 12 cycles of attempt (70% [95% CI, 54%-80%] vs 76% [95% CI, 72%-80%], respectively). Inhibin B levels (n = 737) were not associated with the probability of conceiving in a given cycle (hazard ratio per 1-pg/mL increase, 0.999; 95% CI, 0.997-1.001). Conclusions and Relevance: Among women aged 30 to 44 years without a history of infertility who had been trying to conceive for 3 months or less, biomarkers indicating diminished ovarian reserve compared with normal ovarian reserve were not associated with reduced fertility. These findings do not support the use of urinary or blood follicle-stimulating hormone tests or antimüllerian hormone levels to assess natural fertility for women with these characteristics.
Comparative Studies · Contraception Versus Fertility Awareness
Unseld M et al., 2017·Front Public Health·
Open Access
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.
Zarek SM et al., 2015·J Clin Endocrinol Metab·
Open Access
The objective of the study was to evaluate whether anti-Müllerian hormone (AMH) is associated with fecundability among women with proven fecundity and a history of pregnancy loss.
This was a prospective cohort study within a multicenter, block-randomized, double-blind, placebo-controlled clinical trial ( clinicaltrials.gov , number NCT00467363).
The study was conducted at four US medical centers (2006-2012). Participating women were aged 18-40 years, with a history of one to two pregnancy losses who were actively attempting pregnancy. Time to human chorionic gonadotropin detected and clinical pregnancy were assessed using Cox proportional hazard regression models to estimate fecundability odds ratios (fecundability odds ratios with 95% confidence interval [CI]) adjusted for age, race, body mass index, income, low-dose aspirin treatment, parity, number of previous losses, and time since most recent loss. Analyses examined by preconception AMH levels: low (<1.00 ng/mL, n = 124); normal (referent 1.00-3.5 ng/mL, n = 595); and high (>3.5 ng/mL, n = 483). Of the 1202 women with baseline AMH levels, 82 women with low AMH (66.1%) achieved an human chorionic gonadotropin detected pregnancy, compared with 383 with normal AMH (65.2%) and 315 with high AMH level (65.2%). Low or high AMH levels relative to normal AMH (referent) were not associated with fecundability (low fecundability odds ratios 1.13, 95% CI 0.85-1.49; high FOR 1.04, 95% CI 0.87-1.24). Lower and higher AMH values were not associated with fecundability in unassisted conceptions in a cohort of fecund women with a history of one or two prior losses. Our data do not support routine AMH testing for preconception counseling in young, fecund women.
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, recruited from three centres: 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.
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 three scenarios were tested: (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. Two models were used: (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.
AMH levels are commonly measured in fertility clinics to assess ovarian reserve and give an indication of female fertility potential. AMH levels are useful in deciding on stimulation protocols for IVF cycles. High AMH levels are useful to confirm a diagnosis of polycystic ovaries. Currently AMH levels cannot be used to predict a couple's ability to conceive naturally.
To study the outcomes of women with infertility or miscarriage treated with natural procreative technology (NaProTechnology or NPT), a systematic medical approach to promoting conception in vivo; and to compare the outcomes with those previously published from a general practice in Ireland. Retrospective cohort study. An urban Canadian primary care practice in which the physician had a part-time practice in NPT. Couples with infertility or recurrent miscarriage who received treatment in the practice between August 2000 and July 2006. All couples were taught to identify the fertile time of their menstrual cycles using the Creighton Model FertilityCare System (CrMS) and completed a standard NPT evaluation. Many also received additional medical treatment to enhance conception in vivo. Live birth was the primary outcome; secondary outcomes included conceptions, multiple births, low birth weight, and prematurity. A total of 108 couples received NPT and were included in the analysis, of which 19 (18%) reported having 2 or more previously unexplained miscarriages. The average female age was 35.4 years. Couples had been attempting to conceive for a mean of 3.2 years. Twentytwo participants (20%) had previously given birth; 24 (22%) had previous intrauterine insemination; and 9 (8%) had previous assisted reproductive technology. The cumulative adjusted proportion of first live births for those completing up to 24 months of NPT treatment was 66 per 100 couples, and the crude proportion was 38%. The cumulative adjusted proportion of first conceptions was 73 per 100 couples, and the crude proportion was 47%. Of the 51 couples who conceived, 12 couples (24%) conceived with CrMS instruction alone, 35 (69%) conceived with CrMS and NPT medical treatment, and 4 (8%) conceived after additional surgical treatment. All births were singleton births; 54% were born at 37 weeks' gestation or later; and 78% had birth weights of 2500 g or greater. Natural procreative technology in a family physician's office was effective in treating infertility and miscarriage with outcomes that were comparable to those in an NPT general practice in Ireland. Larger multicentre prospective studies to compare NPT directly to other forms of infertility treatment are warranted.
Comparative Studies · Contraception Versus Fertility Awareness
Introducing a new method into family planning programs requires careful attention to ensure it meets an actual need and has a positive effect on program goals. The Standard Days Method® is a fertility awareness-based method of family planning that is being introduced into family planning programs in countries around the world. It is different from other methods offered by programs, and may bring new couples into family planning, and increase contraceptive prevalence. The study assesses the effect on contraceptive use and prevalence of Introducing Standard Days Method into existing family planning services in whole regions of India, Peru, and Rwanda. In collaboration with the Ministry of Health, health providers were given a contraceptive update on all methods, then trained in counseling on Standard Days Method. Efforts were made to promote demand in the context of informed choice. Routine monthly service statistics in control and intervention areas were used to assess the effect of Standard Days Method introduction at the clinic level; baseline and endline household-based surveys were undertaken to obtain results at the community level (n > 3400 women at endline). Demand for the method is evident in countries with different levels of contraceptive prevalence. The method attracts couples new to family planning, and introducing it into services may increase overall contraceptive prevalence. Introducing Standard Days Method into existing family planning has the potential of benefiting men and women in diverse settings and populations. This study illustrates the critical role of evidence in scaling up a health innovation.
Murcia-Lora JM et al., 2011·pers.bioét.·
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.
Comparative Studies · Contraception Versus Fertility Awareness
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.
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.
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.
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.
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 used proxy measures include: 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.
Fehring RJ et al., 2006·J Obstet Gynecol Neonatal Nurs·
Open Access
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. Outcomes: 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.
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.
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.
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY·
Chapter 34 of Hilgers (2004) examines how NaProTechnology cycle charting may identify women at elevated risk for three gynecologic cancers: endometrial, breast, and ovarian. The chapter presents clinical case series and a small prospective study suggesting that observable cycle biomarkers, particularly patterns indicating suboptimal luteal-phase function, may precede diagnosis and could inform earlier evaluation, while calling explicitly for further research to validate these findings.
Parnell T, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY·
Reproductive outcomes in women aged 35 and older are analyzed using CrMS-monitored cycles, documenting that natural conception remains achievable when ovulatory function and hormonal sufficiency are maintained and underlying pathology is treated. NaProTECHNOLOGY's restorative approach offers an alternative to assisted reproduction for mature-age patients by identifying and correcting specific endocrine or anatomical barriers.
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY·
CrMS charting features -- Peak day definition, pre-Peak mucus quality and duration, post-Peak phase length, and premenstrual spotting -- are systematically compared against sonographic and endocrine findings to demonstrate that prospective cycle observations reliably identify specific ovulation disorder categories. This clinical validation shows that the CrMS chart functions as a non-invasive biomarker map capable of directing targeted ultrasound and hormonal investigation, and that treatment guided by the classification improves ovulatory and fertility outcomes.
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY·
The Creighton Model FertilityCare System (CrMS) is introduced as a standardized, scientifically grounded method for observing and recording cervical mucus biomarkers and bleeding patterns across the menstrual cycle. Its development from earlier natural family planning methods into a fully systematized fertility monitoring tool is traced, establishing the CrMS as the observational substrate for all subsequent NaProTECHNOLOGY medical applications.
Hilgers TW, 2004·The Medical and Surgical Practice of NaProTECHNOLOGY·
NaProTECHNOLOGY applies the standardized biomarkers of the Creighton Model FertilityCare System to identify the specific pathophysiological causes of infertility in each couple, then directs targeted medical or surgical intervention against those causes. Published pregnancy rates demonstrate outcomes comparable to or exceeding IVF in many diagnostic categories, without the ethical, financial, or obstetric risks associated with assisted reproduction.
Tingen C et al., 2003·Environ Health Perspect·
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.
Measurement and Statistics · Instrument Development and Validation
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.
Comparative Studies · Contraception Versus Fertility Awareness
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.
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 indicators of ovulation: 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.
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.
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.
Comparative Studies · Contraception Versus Fertility Awareness
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.
Comparative Studies · Contraception Versus Fertility Awareness
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.
5 major criteria are used to evaluate family planning 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 basically those of estrogens: history of thrombosis, prolonged bedrest, hypertension, hyperlipidemia, hepatic disorders, hormonodependent cancers, or smoking after age 35. Progestin-only methods are available in 3 forms: 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.
Measurement and Statistics · Instrument Development and Validation
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 basal temperature 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.
Sonographic visualization of the cumulus oophorus or of morphologic alterations in the wall of the dominant follicle have been reported to be reliable signs of imminent ovulation when conventional transabdominal sonography is used. To determine if transvaginal sonography could allow a more frequent and confident prediction of imminent ovulation, we prospectively monitored 22 ovulatory menstrual cycles in four women undergoing artificial insemination and in 13 normally menstruating volunteers. Scanning was done on alternate days in the periovulatory period; a 7.5-MHz transvaginal transducer was used. Despite the improved resolution obtained with transvaginal sonography, confident identification of the cumulus oophorus or of mural changes in the follicle was not possible in any of the cycles followed. No other consistent follicular characteristic predicted imminent ovulation. We conclude that confident prediction of imminent ovulation is not possible with sonographic analysis.
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.
Comparative Studies · Contraception Versus Fertility Awareness
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.
Comparative Studies · Contraception Versus Fertility Awareness
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.
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.
Comparative Studies · Contraception Versus Fertility Awareness
This study examined the characteristics and attitudes of 132 married couples who had received training in use of the symptothermal method of natural family planning (NFP). 61% of respondents were 20-30 years of age and over 2/3 had completed college; 59% were Catholic. The largest group of subjects (35%) became aware of NFP through friends, neighbors, and relatives. 71% said they were drawn to NFP because it represented a safe and healthy alternative to other methods of birth control; only 17% gave moral or religious reasons for learning about NFP. 42% of the sample were using NFP at the time of the survey, 32% had discontinued use, and 25% were using fertility awareness in conjunction with barrier methods (combination-continuers). There was a significant difference between these 3 groups in church attendance: 48% of combination-continuers and 67% of continuers compared with 41% of discontinuers attended church once a week or more. The combination-continuer group had more Catholics (50%) than the discontinuer group (37%) but less than the continuers (76%). No significant differences were found between the 3 groups in terms of age, education, or regularity of menstrual cycle length. Over 3/4 of continuers had been married for less than 5 years compared with about 1/2 of those in the 2 other groups. 69% of continuers believed that NFP is extremely effective compared to 13% of discontinuers and 40% of combination-continuers. Spouses encouraged each other in the use of NFP in 88% of combination-continuer couples and 86% of continuer couples, but only about half of discontinuers received such encouragement. Although most NFP advocates emphasize a nonsexual form of abstinence during the fertile period, the vast majority of respondents in this study defined abstinence to include the possibility of orgasm. Combination-continuers, positioned between continuers and discontinuers or both dissatisfaction with other methods and with abstinence, warrant more attention in future NFP research.
Comparative Studies · Discontinuation and Return of Fertility
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 from continuers were: 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.
Comparative Studies · Contraception Versus Fertility Awareness
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.
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. The question is: 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.
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 features were assessed: 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.
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.
Ten ovulating women were studied to assess the interrelationships of various systemic, hormonal, and reproductive tract changes during normal menstrual cycles. Samples of blood, 24 hour urine specimens, vaginal smears, and cervical mucus were obtained every 2 days preand post-menstrually and daily in mid-cycle. Endometrial biopsies were performed at the onset of or immediately before menstruation, and the basal body temperature was recorded. Data for 10 cycles were fed into a computer, and mean reciprocal relationships were determined. The results were: (1) All endometrial biopsies reflected the late secretory phase; (2) there was a simultaneous mid-cycle surge of luteinizing hormone (LH) and folliclestimulating hormone (FSH), and serum concentrations of FSH and LH were significantly lower in the luteal phase compared to the follicular phase; (3) urinary peaks of estrone, estradiol and total estrogens occurred on the day before and that of estriol occurred on the day of the LH surge; (4) serum progesterone began to rise just before the LH peak, reached a high level 7 days after the LH peak, declined precipitately on Day 9, and rose again on Day 10, to decrease slowly until the onset of menstruation; (5) a significant relationship was observed between the LH peak and the basal body temperature; (6) urinary pregnanediol levels closely paralleled serum progesterone concentrations; (7) vaginal cytology revealed a karyopyknotic index peak the day following the LH peak; (8) properties of cervical mucus showed a remarkable relationship to the ovulatory estrogen peak.
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 mucus: 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. Subject: 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).