Peipert et al. (1) claim that restorative reproductive medicine (RRM) originated as a political and religious movement with the purpose to limit access to in vitro fertilization (IVF). In so doing, they mischaracterize the origin, development, and aims of RRM, as articulated by the International Institute for Restorative Reproductive Medicine, founded in 2000. They do not refer to any peer-reviewed medical literature published by clinicians and researchers working to develop RRM. Objecting that certain political or economic interests promote RRM (or, alternatively, IVF) does not constitute the basis for an evidence-based scientific critique or discussion. Thus, their editorial falls short of a serious effort to understand RRM scientifically.
Ethics/PhilosophyInfertility TreatmentProfessional DebateInformed Decision Making
Sánchez-Méndez JI et al., 2025·Front Reprod Health
Assisted reproductive technologies (ART) are widely used to address infertility; however, they are costly, associated with medical risks, and often yield suboptimal clinical outcomes. Natural Procreative Technology, also known as NaProTechnology (NPT), provides a systematic and integrative approach to infertility by thoroughly identifying and treating underlying medical conditions to restore the couple's natural fertility potential. Despite its promise, real-world data on NPT effectiveness remain limited. The objective of this study is to evaluate the take-home baby rate in a large population of infertile couples treated with NPT and to synthesize findings from previously published studies. A retrospective cohort study was conducted involving 1,310 infertile couples treated at a specialized fertility clinic in Spain over a 5-year period. Participants presented with primary or secondary infertility or recurrent pregnancy loss. Clinical data, diagnoses, and outcomes were analyzed, including surgical interventions and treatment duration. The mean age of women and men was 35.0 (SD 4.4) and 36.9 (SD 5.3) years, respectively. Primary infertility was the most common subtype (73.5%), the median infertility duration was 24 months, and prior ART attempts were recorded in 27.5% of couples. Mean number of diagnoses per couple was 2.5 (SD 1.3). The crude take-home baby rate was 35.3% (N = 463). Independent predictors of successful take-home baby included female age, recurrent pregnancy loss as the reason for consultation, duration of infertility, and the presence of endometriosis, hormonal dysfunction, male factor, and endometrial disorders as diagnoses. Considering a median duration of NPT of 10.9 months (range 8.1-17.0), the adjusted cumulative take-home baby rate was 62.1%. Rates varied significantly by female age, with higher success 83.7% at 18-30 years, 53.3% at 36-40 years, and 24.4% over 40 years. A sensitivity analysis was performed to assess the impact of dropout assumptions on cumulative pregnancy rates. Nearly one-third of patients underwent surgery, most commonly hysteroscopy and/or laparoscopy. In this cohort, NPT was associated with a notably high take-home baby rate in an infertile population with unfavorable prognostic factors, including advanced maternal age, prolonged duration of infertility, or previous failed attempts at conventional ART procedures.
RRM MethodsDefinition and PrinciplesPatient AutonomyRRM vs IVF
Open Access
Recently, editorials have been published in reproductive medical journals that have misunderstood and misrepresented the origin and meaning of “restorative reproductive medicine” (RRM).1,2 This term was first used in 2000 when a group of physicians established the International Institute for Restorative Reproductive Medicine (IIRRM, iirrm.org ). I am a founding member and am currently president of the IIRRM.
The IIRRM was founded as a secular, not a faith-based organization. We adhere to time-honoured medical principles to understand and treat underlying factors responsible for infertility. We are always seeking to improve our diagnosis and treatment of those factors, the training of clinicians who offer RRM, and the quality of clinical practice of RRM. We believe that in the clinical realm, in vitro fertilization (IVF) is often offered quickly without sufficient efforts first made to help couples conceive naturally.
IVF was originally developed to treat patients with bilateral tubal occlusion who could not conceive through sexual intercourse. Most patients who undergo IVF today do not have blocked fallopian tubes. Intracytoplasmic Sperm Injection (ICSI) was developed for patients with severe male factor infertility. Most patients who undergo ICSI today do not have severe male factor infertility. Remarkably, the most recent Cochrane review of IVF indicates ongoing uncertainty about whether IVF improves the live birth rate compared to expectant management for previously untreated couples with “unexplained” subfertility.3
I am an active RRM clinician since 1998 and I have treated thousands of couples. When patients present for fertility treatment, I do not ask them what religion, political view, or philosophy they support, because that is irrelevant to people who want a solution for their infertility. If they have a condition that is better treated by IVF, I tell them that at the first appointment. If natural conception is possible with RRM, I explain what is involved and outline the treatment process which can take up to 12 cycles (most often less) to reach a healthy ongoing pregnancy, or a full course of treatment.
RRM honours patient autonomy. We do not seek to prohibit patient access to IVF. Patients seek us out. RRM expands their choices and options. Many of my patients were previously seen in fertility clinics that offer IVF. Patients repeatedly tell me they did not receive the same depth of investigation or non-IVF treatment in the IVF clinics. I recently received these comments from patients, “RRM empowered us in our fertility journey. It provided a personalised approach. We are so grateful.” And “even if we didn’t conceive, we’d never regret trying RRM as my health improved immeasurably…”
The World Health Organization states that “Infertility is a disease of the male or female reproductive system defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse”.4 As RRM physicians, we respectfully suggest a slight “Infertility is a medical condition defined by failure to achieve a pregnancy after 12 months or more of regular sexual intercourse without contraception, which is caused by one or more underlying diseases and conditions involving the male or female reproductive system.” This definition indicates that infertility is not a singular condition to be treated solely by treatments to generate a pregnancy and birth. Rather, it is “a canary in the coal mine” for human health, indicating the need to identify and address underlying health concerns. 5,6
As RRM physicians and clinicians we have training and backgrounds that allow us to treat infertility patients with a focus on treatments and approaches that restore and optimize natural function. The specialty of reproductive endocrinology and infertility has extensive training with a particular focus on IVF and treatments to improve the success of IVF. But we can and should be in agreement to offer patients evidence-based information and treatments that meet the needs and preferences of patients.
Further research is needed and is currently ongoing on patient-relevant questions, How does an RRM evaluation differ in process and results from a fertility evaluation before initiating IVF? How do the outcomes of RRM and IVF compare on multiple levels including live birth rates, premature delivery, patient satisfaction, health improvement, and repeat successful births?7
For the sake of our patients with infertility, let us strive to be objective about the scientific facts, and meet all patients with respect. Surely as we challenge and learn from one another and strive for excellence, the patients will be the ultimate beneficiaries.
InfertilityRRM vs IVF ComparisonLive Birth RatesPrematurity and Birth Weight
Open Access
Restorative reproductive medicine (RRM) is an emerging approach that can be used to treat infertility. Our goal was to compare RRM to IVF outcomes in 2019.
We conducted a retrospective clinic-based analysis and referenced it against publicly available data from IVF registries, as published by the Centers for Disease Control and Prevention (CDC) or the Society for Assisted Reproductive Technology (SART) in the USA, and the Human Fertilization and Embryology Authority (HFEA), in the UK. Data from 2019 was collected from routine medical records following treatment at one clinic in Dublin, Ireland during 2019. We defined the demographics, diagnoses, and treatments and then calculated the crude percentages of conception, live birth, multiple pregnancy, prematurity, and low birth weight. These results were benchmarked against data reported in IVF databases. 249 couples had at least one RRM consultation, 187 committed to the RRM treatment program and met the inclusion criteria. The average female age for all included patients was 36.4 years and couples were trying to conceive for a mean of 32.2 months. Of the 187 patients/couples who underwent treatment, 28% had a previous live birth, 30% had a previous miscarriage, and 42% had never conceived;19% (35/187) had previously had IVF, 2.3 + 1.6 IVF cycles per couple. Of the 187 couples, 52% (98/187) conceived, 41% (77/187) had a documented live birth. There were 75 singletons and 2 sets of twins, producing 79 babies. Time to conception for live birth patients averaged 12 + 8 months. The average birth weight was 3422g (7lb 9oz) and average weeks’ gestation at delivery was 39 + 1.5 weeks. 4.0% (3/75) of singleton babies were premature (33-37 weeks) and none were very premature (< 32 weeks). 5.3% (4/75) of singleton babies had low birth weight (< 2,500g). When we compared births across age groups, the RRM percentages with live birth were comparable to those in a single cycle of IVF with multiple subsequent embryo transfers, and greater than a single cycle of IVF with a single embryo transfer. Furthermore, RRM babies had fewer multiple pregnancies, and singleton RRM pregnancies had less than half as many premature deliveries compared to IVF, (6.5% RRM all pregnancies or 4.0% RRM, singleton pregnancies vs 14.4% SART, all pregnancies or 11.8% CDC, singleton pregnancies). 74% (26/35) of couples who remained in contact with us and tried for another pregnancy had a repeat successful live birth. In our clinic, a comprehensive RRM assessment and treatment followed by up to 12 optimal cycles of timed intercourse resulted in a 41% live birth rate (crude rate). We propose that using RRM may improve a couple’s chance of having a healthy pregnancy and reduce the demand for IVF. Furthermore, RRM reduces the risk of multiple pregnancy, low birth weight and premature delivery compared to IVF. The majority of couples who sought a second live birth were successful.
Limitations This is a retrospective analysis with a small number of RRM patients, compared to large IVF databases of patients using one cycle of IVF, including all transfers made from the IVF retrieval. While useful for benchmarking, conclusions are limited by sample size, and the lack of relevant prognostic data (other than female age) for the IVF patients. Larger prospective studies with full prognostic data are needed to make a proper comparison of RRM and IVF outcomes.
Fertility AwarenessCreighton Model SystemProspective CohortIntentions and Compliance
Open Access
Knowledge of the fertile and infertile phases of the menstrual cycle can be applied to conceive or to avoid pregnancy. Fertility intentions and sexual behaviors during the fertile time may influence whether and when pregnancy occurs. The Creighton Model FertilityCare System (CrMS) is a specific system of fertility appreciation used to conceive or to avoid pregnancy. The objective of this paper is to report intentions, behaviors, and pregnancy rates during use of the CrMS among couples who initially intended to avoid pregnancy.Data and methodsWe analyzed a prospective cohort study conducted in 17 CrMS centers across the USA and Canada, following 296 couples for up to one year after onset of initial use of the CrMS to avoid pregnancy. Baseline data included demographics, motivations, and pregnancy intentions for each partner. Couples contributed 2894 menstrual cycles, most of which had data collected (by questionnaires and daily diary) on cycle-specific pregnancy intentions, days of potential fertility, and fertility behaviors. Pregnancies were prospectively actively ascertained. We found a high concordance (91%) in cycle pregnancy intentions between partners. However, 44% of cycles with strong intentions to avoid pregnancy included intercourse on potentially fertile days or days of undetermined fertility status. Across all sensitivity scenarios, cumulative 13-cycle pregnancy rates with cycle intention to conceive ranged from 88.0% to 89.8%, and cumulative 13-cycle pregnancy rates with cycle intention to avoid ranged from 29.1% to 35.3%. In multivariate analysis, baseline motivations and intentions for pregnancy within 2 years were strongly correlated with the likelihood of pregnancy, more so than cycle intentions. The findings suggest that in some populations using natural family planning, baseline motivations and intentions may be more strongly related to pregnancy rates than cycle intentions. Our findings also highlight essential elements for evaluating correct use, including complete recording of intercourse and its timing.
Fertility AwarenessEvidence ReviewHormone Monitoring and AppsPostpartum and Perimenopause
A one-day meeting was held as a pre-conference to the Catholic Medical Association Annual Educational event in 2024. A panel of eighteen physicians, scientists, and researchers involved in NFP work was convened to review the available (i) evidence for effectiveness of NFP methods to postpone and achieve pregnancy, (ii) evidence for effectiveness in the postpartum and perimenopause transition periods, (iii) evaluate the current state of technology in NFP (specifically app and quantitative hormone monitoring), and (iv) evidence examining the impact of NFP on marital relations. In each topical area, the panel worked to reach a consensus opinion on the currently available evidence and identified priorities for further research. Results from these discussions and a set of priorities for further work are presented here.
An expert panel was convened to review the current evidence supporting use of NFP in various settings, utilization of new technology, and the impact of NFP on marital dynamics. Results from these discussions and a set of priorities for further work are presented here.
RRM MethodsIntegrated Treatment ModelsRestorative vs ARTLaparoscopy and Hysteroscopy
Open Access
Bulletti FM et al., 2025·Clin Med�Insights�Reprod�Health
Infertility affects around 17.5% of reproductive-aged individuals worldwide, posing significant personal and public health challenges. Although Medically Assisted Reproduction and Assisted Reproductive Technology (ART; e.g., in vitro fertilization) have advanced outcomes, many couples fail to conceive due to unaddressed pelvic, uterine, or systemic factors. We aim to (1) define the current usage of Restorative Reproduction Medicine (RRM) in clinical practice, (2) compare RRM outcomes with conventional ART, and (3) propose an integrated model of RRM plus ART for optimal fertility care.
A systematic review following PRISMA guidelines was conducted (INPLASY registration no. INPLASY2024110069). We searched PubMed, Scopus, and Web of Science (January 1995–October 2024), combining terms such as “restorative reproductive medicine,” “intrauterine adhesions,” “myomas,” “polyps,” “hydrosalpinx,” “endometritis,” “BMI,” “thyroid dysfunction,” “microbiome,” and “assisted reproductive technology.” studies on uterine/systemic factors affecting infertility, focusing on surgical/pharmacological RRM interventions and ART limitations. male-only infertility, case reports, narrative reviews, non-English publications. Quality assessment employed the Newcastle-Ottawa Scale and the Cochrane Risk of Bias Tool. We also briefly noted potential publication bias due to language and study-type restrictions. From >25,000 initial titles, 3 sequential screenings yielded 145 key articles addressing uterine (septum, myomas, polyps, adhesions) and systemic (body mass index (BMI) extremes, thyroid dysfunction, microbiome imbalance) factors. Surgical corrections (e.g., hysteroscopic removal of polyps/myomas, salpingectomy for hydrosalpinx) significantly improved natural conception and ART success (⩾20%–40% increase in clinical pregnancy). Chronic endometritis treatment, endometrial microbiome modulation, and BMI/thyroid optimization further improved pregnancy rates by 15%–20%. Comparisons of RRM versus ART alone indicated that RRM often lowers overall cost and may reduce miscarriage, while ART offers immediate embryo transfer. Combining RRM to correct pathologies prior to ART can boost implantation and live birth rates (⩾40%–70% improvement in some studies). Restorative Reproductive Medicine comprehensively addresses pelvic and systemic abnormalities, thereby enhancing fertility outcomes and complementing ART. A proposed integrated model—RRM diagnostics/interventions followed by ART if needed—maximizes success, reduces time/cost, and emphasizes holistic reproductive health. Further multicenter trials are warranted to standardize protocols and fully realize RRM’s potential in modern fertility care.
Fertility AwarenessResidency TrainingPhysician KnowledgeClinical Education
Open Access
Damba-Cunningham E et al., 2025·J Restorative Reprod Med
Fertility awareness-based methods (FABM) of family planning have increased in popularity in recent years. The effectiveness of various methods can vary substantially and can be user dependent. For various reasons, there is a bias in OBGYN physicians against the use of FABMs for family planning. However, once educated about the methods of FABMs, this bias improves. There is limited regarding the education dedicated to FABM use in residency. We hypothesized that the residency education obtained regarding FABMs would be insufficient in preparing resident OBGYNs in effectively counseling patients regarding FABMs. a 16-question survey was created via SurveyMonkey and was sent to all ACGME accredited OBGYN residency programs for distribution to current residents. The survey was administered from October 2023 to December 2023. 125 responses were collected. Less than 40% of residents received formal training in regards to FABMs. Respondents indicated they felt most comfortable describing the calendar method to patients (68% respondents agree or strongly agree when queried if they could describe the method). 79.5% of respondents could not describe mucus-only, hormone monitoring, or sympto-thermal methods of family planning. When questioned if they were prepared to counsel postpartum patients who refused contraception regarding FABM, 58% of respondents indicated they could not assist their patients. Despite increased use in recent years and multiple options for FABM use, resident education in the application and use of FABMs is lacking. Additionally, residents indicated they are most familiar with the least effective methods (calendar method) which would likely be a significant detriment to their patients.
DiagnosticsUrinary MetabolitesHormonalClinical Outcomes
Open Access
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.
SurgeryExcision TechniquesSurgical ManagementFertility Outcomes
Open Access
Restorative reproductive surgery has emerged to become an exciting and promising field of surgery that can transform the way that we treat patients, especially regarding fertility. As a prime example of this type of surgery, restorative reproductive surgery for endometriosis, a common and debilitating disease that can lead to infertility and pelvic pain, offers a root cause treatment to remove the actual disease and to optimize the reproductive anatomy, for best patient outcomes. Optimal excision of endometriosis and prevention of pelvic adhesions has been shown to lead to reduce symptoms, to lead to high natural fertility rates, and to lead to very low rates of the need for repeat surgery. Patients have improved symptoms and quality of life, in addition to improved fertility chances for one and subsequent pregnancies (if desired), demonstrating the link between wellness and fertility.
There is an urgent need for more resources, training, advocacy, research and publication for this exciting area of restorative reproductive surgery. Its time has come.
NaProTECHNOLOGYFoundational PrinciplesClinical ApplicationRestorative Approaches
Open Access
In 1972, a seminal article was published demonstrating that women, adequately trained, could detect the approach of ovulation in the fertile window of their menstrual cycle. It was demonstrated that the symptoms perceived by women at the vulva correlate closely with changes in steroid hormone levels associated with folliculogenesis and the luteal phase. The fertility charting performed by women trained to recognize vulvar symptoms associated with hormonal changes serves as an instrument for detecting potential pathologies and monitoring the effects of treatment These findings established the biological foundations of a tool of fertility awareness tracking that has facilitated the development of restorative reproductive medicine (RRM): an approach that can be applied to identify and treat the underlying causes of infertility/subfertility.
Several core characteristics—or foundational pillars—of the RRM approach to fertility can be identified. a commitment to respecting healthy physiological processes, comprehensive health care for both the couple and the potential embryo, and the provision of education and continuous support throughout the therapeutic process.
This commentary aims to elucidate the interplay of these foundational pillars by drawing upon evidence from peer-reviewed biomedical literature. Finally, the challenges faced by RRM in strengthening its scientific foundations, engaging with the broader scientific community, and promoting the dissemination of this approach are described.
NaProTECHNOLOGYRestorative Reproductive Medicine OverviewDefinition and FrameworkBiomarker-Based Medical Evaluation
Open Access
Welcome to the Journal of Restorative Reproductive Medicine, the official journal of the International Institute for Restorative Reproductive Medicine! JRRM is a peer-reviewed, open-access medical journal for clinicians, scientists, professionals, and patients. Our vision is that JRRM will disseminate and promote evidence-based information to support and restore human fertility and reproductive health. Restorative reproductive medicine can be defined as approaches to systematically identify and treat underlying health conditions contributing to reproductive dysfunction and suboptimal reproductive health.1,2 In the case of subfertility, the aim is to restore the ability to have a healthy live birth, starting with natural intercourse in the fertile window.3 Consistent with this, JRRM approaches subfertility and recurrent miscarriage as related chronic conditions with many possible underlying contributors, including medical conditions, lifestyle, and environmental factors. The same framework applies to other conditions affected by or affecting human reproductive health, which is intertwined with somatic health.4-6 JRRM is particularly interested in articles from clinical medicine, physiology, epidemiology, data science, social sciences, and public health. Relevant clinical domains include, but are not limited to gynecology, andrology, endocrinology, infertility, midwifery, primary care, fertility cycle tracking. Occasionally, basic science or animal studies might be considered for publication, if they directly relate to the vision of JRRM. Articles not considered relevant to this journal include those focusing on the humanities or medical ethics, or research that does not focus on a restorative approach to human fertility and reproductive health. JRRM builds on a long history of tracking ovulation and the fertile window with fertility biomarkers, originally with the aim of natural regulation of fertility.7-10 In the past few decades, clinicians and investigators have explored the power and potential of applying these tools to medical evaluation and treatment.11-13 JRRM seeks to highlight and accelerate the development of scientific evidence linking fertility biomarkers and health. There are a growing number of high-quality journals related to human reproduction. JRRM focuses uniquely on restorative approaches to investigation and treatment, which often get less attention. There is a wide variety of motivations for the interest and engagement of patients and professionals in restorative preferences for less invasive natural approaches, commitments to patient empowerment, seeking answers for what is wrong, concerns about access and quality, reducing costs, and ethical and religious commitments.14-16 We all can benefit from a diversity of perspectives in the service of patients.17 All motivations are welcome at JRRM, as we focus together on a restorative approach to fertility and reproductive health
Fertility awareness-based methods (FABMs), also known as natural family planning (NFP), enable couples to identify the days of the menstrual cycle when intercourse may result in pregnancy ("fertile days"), and to avoid intercourse on fertile days if they wish to avoid pregnancy. Thus, these methods are fully dependent on user behavior for effectiveness to avoid pregnancy. For couples and clinicians considering the use of an FABM, one important metric to consider is the highest expected effectiveness (lowest possible pregnancy rate) during the correct use of the method to avoid pregnancy. To assess this, most studies of FABMs have reported a method-related pregnancy rate (a cumulative proportion), which is calculated based on all cycles (or months) in the study. In contrast, the correct use to avoid pregnancy rate (also a cumulative proportion) has the denominator of cycles with the correct use of the FABM to avoid pregnancy. The relationship between these measures has not been evaluated quantitatively. We conducted a series of simulations demonstrating that the method-related pregnancy rate is artificially decreased in direct proportion to the proportion of cycles with intermediate use (any use other than correct use to avoid or targeted use to conceive), which also increases the total pregnancy rate. Thus, as the total pregnancy rate rises (related to intermediate use), the method-related pregnancy rate falls artificially while the correct use pregnancy rate remains constant. For practical application, we propose the core elements needed to assess correct use cycles in FABM studies.
Fertility awareness-based methods (FABMs) can be used by couples to avoid pregnancy, by avoiding intercourse on fertile days. Users want to know what the highest effectiveness (lowest pregnancy rate) would be if they use an FABM correctly and consistently to avoid pregnancy. In this simulation study, we (1) the method-related pregnancy rate; and (2) the correct use pregnancy rate. We show that the method-related pregnancy rate is biased too low if some users in the study are not using the method consistently to avoid pregnancy, while the correct use pregnancy rate obtains an accurate estimate. In FABM studies, the method-related pregnancy rate is biased too low, but the correct use pregnancy rate is unbiased.
Fertility AwarenessMedical TrainingCurriculum DevelopmentFABM Knowledge
Open Access
Fertility awareness-based methods (FABMs) are evidence-based means of tracking observable biomarkers of a woman's fertility for the purpose of reproductive health monitoring and family planning. However, medical education regarding FABMs is limited. The purpose of this study was to examine the effect of a 4-week, two-part online elective on students' knowledge of FABMs, confidence in explaining and offering them to patients, and anticipated behaviors in future practice. The online elective, "FABMs for Family Planning and Women's Health," was delivered from August 2020 to May 2023. Students completed preand postknowledge surveys. Paired t tests and the Wilcoxon signed rank test were used for analysis of the data. A total of 571 students completed the elective, and 462 students completed both preand posttest surveys (response rate=81%). Students' knowledge of FABMs increased significantly. Posttest scores increased by a mean of 9.02 for Part A and 5.95 for Part B. We identified a significant increase in students' confidence discussing FABMs to avoid pregnancy, achieve pregnancy, monitor reproductive health, and address reproductive health concerns. At the completion of the elective, students were significantly more likely to offer FABMs as an option for most or all women. This online elective addresses the knowledge gap in FABMs and was effective in improving students' knowledge of FABMs and their confidence and willingness to offer these methods to patients for family planning and management of common women's health conditions.
General OB/GYNLow-Dose NaltrexoneLDN ImmunomodulationDrug Repurposing
Open Access
Naltrexone (NTX) is a non-selective antagonist of opioid receptors, primarily used in the therapy of opioid and alcohol dependence. Low-dose naltrexone (LDN) exhibits antagonistic action against the opioid growth factor receptor (OGFr), whose signaling is associated with the survival, proliferation, and invasion of cancer cells. The mechanism of action of LDN depends on the dose and duration of the OGFr blockade, leading to a compensatory increase in the synthesis of the opioid growth factor (OGF), which has an inhibitory effect on carcinogenesis. Numerous studies on in vitro and in vivo models provide evidence of LDN's positive impact on inhibiting the OGF-OGFr axis in cancers. LDN's unique mechanism of action on cancer cells, lack of direct cytotoxic effect, and immunomodulating action form the basis for its use as an adjuvant in chemotherapy and immunotherapy of cancerous lesions.
Perimenopause/MenopauseHormone TrackingUrinary Hormone MonitoringPerimenopause
Open Access
The fertility tracking of menstrual cycles during perimenopause with a quantitative hormone monitor is a novel undertaking. Women in regular menstrual cycles have been tracking their fertility using different biomarkers since the 1960's. Presently, there are newer electronic hormonal devices used to track fertility that provide more exact and objective data to help delineate the fertile time frame of a woman's cycle. These devices measure quantitative levels of estrogen, the luteinizing hormone, progesterone, and follicle-stimulating hormone, all of which occur at varying levels during the menstrual cycle. As women advance toward menopause, their cycles vary in length, and their hormones fluctuate. In this retrospective analysis, forty-two women aged 40 to 50 tracked their cycles over time, and eight of these forty-two women used the quantitative hormonal device. With the use of this device, the perimenopausal period has revealed distinct hormonal cycle characteristics that are unique to this group of women. It is the purpose of this paper to discuss these cycle's characteristics during perimenopause, which were found with the use of the quantitative hormonal device.
RRM MethodsTeachingProfessional TrainingUnexplained
Open Access
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. 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. 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. s?
The level of knowledge, awareness, and positive perception of NaProTechnology among the pharmacy undergraduates students were poor prior to a video intervention but 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.
SurgeryModern Role and EvolutionSurgical vs ARTFertility Preservation
For years, reproductive surgery was the mainstay of reproductive care. With the evolution and ultimate success of in vitro fertilization (IVF), reproductive surgery became an adjuvant therapy, indicated mainly for severe symptoms or to enhance success rates with assisted reproductive technologies. As success rates for IVF have plateaued, and emerging data rekindles the enormous benefits of surgically correcting reproductive pathologies, there is renewed interest among reproductive surgeons in reviving research and surgical expertise in this area. In addition, new instrumentation and surgical techniques to preserve fertility have gained traction and will solidify the need to have skilled reproductive endocrinology and infertility surgeons in our practice.
Body LiteracyMedical School CurriculaPhysician TrainingMedical Education Gaps
Knowledge and competency in the topics of reproductive health and family planning are important for primary care physicians. Given the high rates of unintended pregnancy, increasing rates of infertility and other gynecologic conditions, it is important for medical students, many of whom will become primary care physicians, to receive good foundational knowledge of reproductive health topics. The objective of this research project was to investigate the current curricula at US medical schools to determine the breadth and extent of education that medical students receive in reproductive health. Medical students and faculty at 20 US medical schools shared all relevant materials from their required reproductive health curriculum used between 2016-2019, including syllabi, PowerPoint lectures, and official class handouts that were available to all students. From these, the number of mentions of 69 reproductive health-related terms were counted, including those related to family planning methods, abortion, ectopic pregnancy, reproductive counseling, and infertility. Of the over 9000 mentions of reproductive health terms, approximately half of mentions were related to family planning, with 10% related to abortion, 10% to infertility, and 6% to reproductive counseling. Family planning strategies emphasized oral contraceptives and long-acting reversible contraceptives with limited mentions of natural or fertility awareness-based methods. This data demonstrates opportunities for broadening reproductive health education in medical school so that future primary care physicians are prepared to discuss the full range of reproductive options for their patients.
What is the feasibility of a prospective protocol to follow subfertile couples being treated with natural procreative technology for up to 3 years at multiple clinical sites? Overall, clinical sites had missing data for about one-third of participants, the proportion of participants responding to follow-up questionnaires during time periods when participant compensation was available (about two-thirds) was double that of time periods when participant compensation was not available (about one-third) and follow-up information was most complete for pregnancies and births (obtained from both clinics and participants). Several retrospective single-clinic studies from Canada, Ireland and the USA, with subfertile couples receiving restorative reproductive medicine, mostly natural procreative technology, have reported adjusted cumulative live birth rates ranging from 29% to 66%, for treatment for up to 2 years, with a mean women's age of about 35 years. The international Natural Procreative Technology Evaluation and Surveillance of Treatment for Subfertility (iNEST) was designed as a multicenter, prospective cohort study, to enroll subfertile couples seeking treatment for live birth, assess baseline characteristics and follow them up for up to 3 years to report diagnoses, treatments and outcomes of pregnancy and live birth. In addition to obtaining data from medical record abstraction, we sent follow-up questionnaires to participants (both women and men) to obtain information about treatments and pregnancy outcomes, including whether they obtained treatment elsewhere. The study was conducted from 2006 to 2016, with a total of 10 clinics participating for at least some of the study period across four countries (Canada, Poland, UK and USA). The 834 participants were subfertile couples with the woman's age 18 years or more, not pregnant and seeking a live birth, with at least one clinic visit. Couples with known absolute infertility were excluded (i.e. bilateral tubal blockage, azoospermia). Most women were trained to use a standardized protocol for daily vulvar observation, description and recording of cervical mucus and vaginal bleeding (the Creighton Model FertilityCare System). Couples received medical and sometimes surgical evaluation and treatments aimed to restore and optimize female and male reproductive function, to facilitate in vivo conception. MAIN The mean age of women starting treatment was 34.0 years; among those with additional demographic data, 382/478 (80%) had 16 or more years of education, and 199/659 (30%) had a prior live birth. Across 10 clinical sites in four countries (mostly private clinical practices) with family physicians or obstetrician-gynecologists, data about clinic visits were submitted for 60% of participants, and diagnostic data for 77%. For data obtained directly from the couple, 59% of couples had at least one follow-up questionnaire, and the proportion of women and men responding to fill out the follow-up questionnaires was 69% and 67%, respectively, when participant financial compensation was available, compared to 38% and 33% when compensation was not available. Among all couples, 57% had at least one pregnancy and 44% at least one live birth during the follow-up time period, based on data obtained from clinic and/or participant questionnaires. All sites reported on female pelvic surgical procedures, and among all participants, 22% of females underwent a pelvic diagnostic and/or therapeutic procedure, predominantly laparoscopy and hysterosalpingography. Among the 643 (77%) of participants with diagnostic information, ovulation-related disorders were diagnosed in 87%, endometriosis in 31%, nutritional disorders in 47% and abnormalities of semen analysis in 24%. The mean number of diagnoses per couple was 4.7. LIMITATIONS The level of missing data was higher than anticipated, which limits both generalizability and the ability to study different components of treatment and prognosis. Loss to follow-up may also be differential and introduce bias for outcomes. Most of the participating clinicians were not surgeons, which limits the opportunity to study the impact of surgical interventions. Participants were geographically dispersed but relatively homogeneous with regard to socioeconomic status, which may limit the generalizability of current and future findings. Multicenter studies are key to understanding the outcomes of subfertility treatments beyond IVF or IUI in broader populations, and the association of different prognostic factors with outcomes. We anticipate that the iNEST study will provide insight for clinical and treatment factors associated with outcomes of pregnancy and live birth, with appropriate attention to potential biases (including adjustment for potential confounders, multiple imputation for missing data, sensitivity analysis and inverse probability weighting for potential differential loss to follow-up, and assessments for clinical site heterogeneity). Future studies adequate funding to compensate clinics and participants for robust data collection, including targeted randomized trials; or a scaled-down, registry-based approach with targeted data points, similar to the multiple national and regional ART registries. Funding for the study came from the International Institute for Restorative Reproductive Medicine, the University of Utah, Department of Family and Preventive Medicine, Health Studies Fund, the Primary Children's Medical Foundation, the Mary Cross Tippmann Foundation, the Atlas Foundation, the St. Augustine Foundation and the Women's Reproductive Health Foundation. The authors declare no competing interests. The iNEST study is registered at clinicaltrials.gov, NCT01363596.
Restorative reproductive medicine represents a comprehensive approach to subfertility (infertility and miscarriage) with investigations, diagnoses, and treatments combined with fertility charting to restore optimal reproductive function. Restorative reproductive medicine assumes that multiple factors need to be identified and treated (cycle optimization) for up to 12 cycles to achieve a successful pregnancy. Conception can occur during normal intercourse without intrauterine insemination or in vitro fertilization. A 35-year-old Croatian female presented for fertility treatment in May 2019 with a previous diagnosis of polycystic ovaries, infertility of 16 years duration, and 8 unsuccessful embryo transfers with in vitro fertilization and intracytoplasmic sperm injection. She was gravida 3 para 0, with 2 miscarriages after spontaneous conception at 5-6 weeks gestation in 2002 and 2004, followed by a miscarriage after in vitro fertilization at 12 weeks gestation in 2011. We initially found poor follicle function and suboptimal progesterone levels. Restorative reproductive medicine treatment resulted in conception after two cycles of treatment. This pregnancy ended in miscarriage at 7 weeks 4 days. Additional investigations found a balanced Robertsonian translocation (13, 14) and a uterine septum. We achieved repeat fertilization with restorative reproductive medicine after three cycles of treatment following resection of the uterine septum and ovulation induction with letrozole and human chorionic gonadotrophin. She had a full-term healthy pregnancy and live birth in 2021. We propose that a full evaluation of underlying factors, and up to 12 cycles of cycle optimization, should be offered to subfertile patients before considering in vitro fertilization treatment.
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.
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.
NaProTECHNOLOGYEffectiveness and EthicsDiagnostic Applications
NaProTECHNOLOGY – a chance for offspring or fraud? In the media space in Poland, you can meet the concept of Naprotechnology as an alternative to the in vitro procedure. Often, many myths and untruths appear in the discussion regarding this method of treatment. Naprotechnology is a new look at the health of women and men created by prof. Thomas Hilgers. It takes into account natural fertility biomarkers thanks to observation with the Creighton Model based on the female mucus. At every stage of diagnosis and treatment, Naprotechnology respects human life from the moment of conception and the mutual dignity of the spouses. It also does not use assisted reproductive procedures for ethical reasons. Naprotechnology is part of the broader scientific discipline of restorative medicine in infertility. Thanks to the accurate diagnosis and observation of the cycle, it is possible to correctly diagnose the cause of infertility. A proper diagnosis is the starting point for the implementation of specialized pharmacological and surgical treatment for both women and men. Properly used Naprotechnology and restorative medicine are highly effective in treating marital infertility. W przestrzeni medialnej w Polsce można spotkać pojęcie Naprotechnologii jako alternatywy dla procedury in vitro. Często w dyskusji pojawia się wiele mitów i nieprawdy dotyczących takiego sposobu leczenia. Naprotechnologia, stworzona przez prof. Thomasa Hilgersa, jest nowym spojrzeniem na zdrowie kobiety i mężczyzny. Uwzględnia ona naturalne biomarkery płodności dzięki obserwacji za pomocą Modelu Creighton bazującego na kobiecym śluzie. Na każdym etapie diagnostyki i leczenia Naprotechnologia szanuje ludzkie życie od samego poczęcia oraz wzajemną godność małżonków. Nie stosuje ona też procedur wspomaganego rozrodu z powodów etycznych. Naprotechnologia jest częścią szerszej dyscypliny naukowej, jaką jest przyczynowe leczenie niepłodności. Dzięki dokładnej diagnostyce i obserwacji cyklu możliwe jest postawienie prawidłowej diagnozy dotyczącej przyczyny niepłodności. Właściwa diagnoza jest punktem wyjścia dla wdrożenia specjalistycznego leczenia farmakologicznego i chirurgicznego zarówno wobec kobiety, jak i mężczyzny. Prawidłowo stosowana Naprotechnologia i przyczynowe leczenie niepłodności cechują się wysoką skutecznością leczenia niepłodności małżeńskiej.
While we agree with many of the points stated by Dyer et al. in their recent commentary inRBMO(Dyer et al., 2020), we believe their conclusions are focused too narrowly. Limiting the indicator of access to, and utilization of, fertility treatment to assisted reproductive technology (ART) excludes information that is of key importance for subfertile couples, populations, and policymakers. Even in countries where access to ART is widespread, there are more births in subfertile couples through non-ART treatment than through ART (Stanford et al., 2016).
While ART is necessary for some couples to have a child, it is not required for many subfertile couples, and overuse of ART may potentially be harmful (Annual Capri Workshop Group 2019). Focusing solely on ART as a metric may unnecessarily encourage overutilization (Boltz et al., 2017).
We believe the focus on ART and its outcomes for national and international registries of fertility treatment has stunted the scientific development of non-ART treatments, including those which seek to address underlying health conditions (Boyle et al., 2018). There is a pressing and critical need to develop robust registries of couples treated with non-ART treatments, for the improvement of outcomes and the promotion of robust consumer choice. (Spandorfer, 2020).
The ultimate measure of access to fertility care should be determined by the proportion of those with a desire for fertility who achieve a healthy live birth, whether or not ART is required to do so (Mascarenhas et al., 2012). Therefore, notwithstanding methodologic challenges, registry assessments should be developed and supported for all fertility treatments, not only ART.
One aspect of the progressive secularization of biotechnology is the use of the by-products from abortion and the use of human embryos. These morally illicit cells and tissue create a significant moral and economic challenge for Catholics at different stages of their career. A practicing Catholic physician or scientific professional will face the dilemma of how to reconcile their Catholic identity with their profession. While the Catechism is clear on what actions Catholics should not pursue, there has been less religious guidance on what activities Catholics should proactively pursue in their professional life to advance the Catholic culture. This essay will examine these themes through the lens of a true story of the author's experience in starting Catholic for-profit and nonprofit biotechnology organizations.
Abortion and the destruction of human embryos create a moral dilemma for Catholics at different stages of a physician or scientist's career. A practicing Catholic physician or scientist must reconcile their Catholic identity with their profession. While there is little professional guidance on how to advance the culture, Jesus says that one must take up the cross and direct their God-given gifts towards His name. The only way to succeed and thrive in a secular healthcare environment is to emulate Jesus by putting aside their own self-interest; pray for courage against ridicule; accept risk; and pursue scientific and medical excellence.
Mirkes R, 2020·The National Catholic Bioethics Quarterly
This How does the Catholic Church guide infertile couples to exercise their right to build a family? Part One examines the principal tenets of Catholic social teaching on human rights in general. Part Two focuses in particular on the Church’s guidelines regarding the right to family planning for infertile couples. And Part Three contrasts NaProTechnology protocols for infertility with in vitro fertilization and concludes that NaPro provides infertile couples not only a responsible means of conceiving a baby that remedies the injustice of in vitro fertilization but also a medical embodiment of the Church’s teaching on the right to family planning.
NaProTECHNOLOGYOverview and Clinical ApplicationsWomen's Healthcare
A special course on Marriage, the Family and Human Sexuality was established at Kenrick-Glennon Seminary in St. Louis so as to assist the seminarians in their better understanding of the Church's teaching relative to natural methods of family planning and women's health care. This article compares the response at the beginning of this three-credit semester course to the same seven-item questionnaire given at the conclusion of the course. The preand postcourse scores were calculated for each of the questions. The scores obtained after the course were all significantly higher than they were before the course with p values ranging from 0.01 to <0.0001. Four of the items showed marked improvement including an understanding of the church's teaching related to natural methods, current methods of natural family planning, the impact of a natural method on a couple's marriage, and also the impact of a natural method on family life. Statistically significant improvement was also seen in their understanding of the topic of natural family planning and the Creighton Model System and its relevance toward the seminarian's vocation, the use of the methods to either achieve or avoid pregnancy, and how contraception and abortion are linked. In these last three items, the level of statistical significance was quite high, although not as high as the other four items. There were 104 seminarians over an eight-year period of time, who provided answers to these questions, both before and after the course. This course was modeled after a course that was initiated at the Pope Paul VI Institute for the Study of Human Reproduction, which was for priests, seminarians, and Catholic leaders, titled Love & Life Unlimited. This is an evaluation of a ten-point, seven-question questionnaire that was utilized at the beginning of a course at Kenrick Seminary in Marriage, Sexuality, Creighton Model and NaProTECHNOLOGY. The same questionnaire was given to the students at the beginning of the course and then two to three months later at the conclusion of the three-credit course. The results show that there is a significant improvement in the seminarians' knowledge and general attitude about natural methods of family planning and suggests that such courses would be beneficial to establish in seminaries throughout the country.
Identifying the return of fertility with cervical mucus observations is challenging during the postpartum period. Use of urinary measurements of estrogen and progesterone can assist in understanding the return to fertility during this period. The purposes of this study were to describe the postpartum return of fertility by an analysis of total estrogen (TE) and pregnanediol glucuronide (PDG) profiles and to correlate these profiles with cervical mucus observations. Twenty-six participants collected urine samples during the postpartum period and recorded mucus scores. TE and PDG hormones were analyzed and compared with mucus scores. During amenorrhea, mucus reflected TE changes in only 35 percent of women; after amenorrhea, typical mucus patterns were seen in 33 percent of cycles. We concluded that postpartum mucus and hormone profiles are significantly dissociated but that monitoring urinary hormones may assist in identifying the return of fertility. We also identified different hormonal patterns in the return to fertility. The postpartum period is a challenging time for identifying the return of fertility. The purposes of this study were to describe the hormonal patterns during the return of fertility and to correlate these patterns with cervical mucus observations. Twenty-six postpartum women collected urine samples and recorded mucus scores. Urinary estrogen and progesterone hormones were analyzed and compared with mucus scores. Before the return of menses, mucus reflected hormonal changes in only 35 percent women and after first menses in 33 percent of cycles. We found that hormone profiles do not correlate well with mucus observations during the postpartum return of fertility.
Fertility AwarenessNFP Science State AssessmentModern NFP EffectivenessFuture Research Priorities
A one-day meeting of physicians, professional nurses, and scientists actively involved in Natural Family Planning (NFP) research was held to review the state of the science of NFP and consider future priorities. The (i) determine the gaps in research evidence for secure methods of NFP among women of all reproductive categories, (ii) determine the gaps in the research and development of new technology for providing NFP services, (iii) determine the gaps in the research that determine the benefits and challenges with use of NFP among married couples, and (iv) provide prioritized ideas for future research needs from the analysis of evidence gaps from objectives above. This article summarizes the discussion and conclusions drawn from topics reviewed. While much has been accomplished in the fifty years since Humane vitae, there are still many gaps to address. Five areas for future research in NFP were (1) well-designed method effectiveness studies among various reproductive categories including important subpopulations (postpartum, perimenopause, posthormonal contraceptive), normally cycling women (especially US women), and comparative studies between NFP methods; (2) validation studies to establish the benefit of charting fertility signs (both currently known and potential new indicators) as a screening tool for women's health issues; (3) ongoing independent evaluation of fertility monitoring apps to provide users perspective on the relative merits of each and to identify those most worthy of further effectiveness testing; (4) studies evaluating the impact of new technologies on NFP adoption, use, and persistence; and (5) creation of a shared database across various NFP methods to collaborate on shared research interests, longitudinal studies, and so on. This summarizes a meeting to review the scientific and medical progress related to natural family planning made in the 50 years since Humane Vitae and to define priorities for future work. Areas reviewed included the evidence for avoiding pregnancy in normally cycling, postpartum, and perimenopausal women, the impact of new technology, including fertility charting apps, on NFP, and the impact on relationships and personal well-being from use of NFP. Five priority focus areas for future research were also identified.
NaProTECHNOLOGYPost-IVF RRM TreatmentLive Birth RatesRRM vs IVF Outcomes
Open Access
To determine the live birth rate for patients who chose to undergo treatment with Restorative Reproductive Medicine (RRM) after previous IVF (includes ICSI). To look at birth outcomes with RRM after IVF, particularly rates of twin and higher order pregnancies, premature birth, low birth weight, and potential cost savings achieved with RRM. Two outpatient clinics in Ireland providing advanced RRM treatment of infertility. All patients presenting between January 2004 and January 2010, with a history of infertility and previous IVF treatment were included if they proceeded beyond the initial consultation and began treatment. Main outcome is live birth per couple calculated using life table analysis. 403 patients met the study criteria, among which 74 had a subsequent live birth. These women had significant negative predictive characteristics for advanced reproductive age (average 37.2 years), an average of 5.8 years of infertility with 2.1 (range 1-9) previous IVF attempts, with only 5% having previously had a live birth from IVF. Despite these undesirable prognostic indicators, the overall RRM live birth rate was 32.1% (crude 18.4%). Women aged 35-38 had a live birth rate of 37.5% (crude 23.6%) and older women over 40 had a live birth rate of 27.4% (crude 16.0%). The average birth weight was 3374g (7lb 7oz) with 92% being born at 37+ weeks and no very low birth weight babies. There was only one twin pregnancy in the study population; the potential health care savings for avoidable multiple pregnancies in these patients was estimated at £205 672 (USD$284 915). Patients who have already tried IVF can achieve comparable live birth outcomes with RRM compared to another cycle of IVF. RRM has a low risk of twin or multiple births, and very good neonatal outcomes with a potential cost savings to the health care system.
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.
Fertility AwarenessQuarterly Evidence SummaryMethod Comparison UpdatesReproductive Health Digest
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.
Reproductive EndocrinologyHormonal Predictors of DeficiencyPreovulatory-Luteal Phase RelationshipsCycle Hormone Pattern Analysis
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 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.
InfertilityTamoxifen for Thin EndometriumEndometrial Thickness ImprovementClomiphene Alternative Approaches
Open Access
Gonadotropin stimulation is used as the second line of treatment in patients with thin endometrium following clomiphene citrate (CC) administration, which is associated with higher cost, multiple births, and ovarian hyperstimulation syndrome. Tamoxifen (TMX), a selective estrogen receptor modulator, acts as an agonist on the endometrium. The objective of the present study was to compare the efficacy of low-dose CC, TMX, and gonadotropins in women with thin endometrium (<7 mm) following Clomiphene in intrauterine insemination (IUI) cycles. A prospective observational study between December 2011 and June 2013 was carried out in a tertiary infertility center. Women (n = 502) undergoing IUI with endometrium <7 mm after 100 mg CC were included in the study and divided into three treatment groups. Women in Group A (n = 182, cycles = 364) received clomiphene (50 mg/day from day 3 to 7), Group B (n = 179, cycles = 342) received TMX (40 mg/day from day 3 to 7), and Group C (n = 141, cycles = 226) received continuous urine-derived follicle-stimulating hormone 75-150 IU from day 3 onward until human chorionic gonadotropin injection. Endometrial thickness (ET), pregnancy rate, and live birth rate were considered as main outcome measures. Multiple comparisons using one-way ANOVA and Schiff's test were performed. Pregnancy and live birth rate were significantly higher (P < 0.004) in TMX and gonadotropin groups compared to clomiphene. A number of follicles in the TMX group were found to be lower (P < 0.001) compared to other two groups. In polycystic ovary syndrome patients, ovulation induction with TMX resulted in inadequate response in more than half of the cycles. TMX can improve ET and live birth rate in patients with thin endometrium after clomiphene.
Fertility AwarenessFertile Window IdentificationPrimary Care Pregnancy AchievementNatural Fertility Indicator Effectiveness
Open Access
To determine the effectiveness of achieving pregnancy with focused intercourse in the fertile window identified using natural fertility indicators. 24-cycle prospective effectiveness study.
A North American web-based fertility monitoring service. 256 North American women aged 20-43 (mean age 29.2 years) seeking to achieve pregnancy. Participants identified their fertile window with either electronic hormonal fertility monitoring or cervical mucus monitoring, or both, and recorded their observations on an online fertility tracking system. Pregnancies were validated by nurses with an online self-assessed pregnancy evaluation form. Survival analysis was used to determine pregnancy rates. There were 150 pregnancies among the 256 participants with an overall pregnancy rate of 78 per 100 women over 12 menstrual cycles. There were 54 pregnancies (68%) among the 80 women using the fertility monitor, 11 pregnancies (46%) among the 24 women using mucus monitoring, and 90 (63%) among the 143 women using both mucus and monitor. The 12-cycle pregnancy rates per 100 women were 83 (monitor group), 72 (mucus group), and 75 (mucus and monitor group). Pregnancy rates reached 100% at 24 cycles of use for those women using the hormonal fertility monitor. Use of the hormonal fertility monitor alone seems to offer the best natural estimate of the fertile phase of the menstrual cycle for women wishing to achieve a pregnancy. Focusing intercourse through 24 menstrual cycles can be beneficial for achieving pregnancy.
RRM MethodsCEIBA Study Enrollment and MotivationsNFP Couple IntentionsCreighton Model Effectiveness Study
Open Access
The Creighton Model FertilityCare(TM) System (CrM) is a standardized approach for educating women about the biomarkers of their fertility. Couples can use this information for timing intercourse during "fertile" or "infertile" days in order to try to conceive or to avoid pregnancy. The study of Creighton Model Effectiveness, Intentions, and Behaviors Assessment (CEIBA) was conducted to assess fertility motivations, intentions, fertility-related sexual behaviors, and their impact on effectiveness to avoid and to conceive among new users of the CrM. This paper reports enrollment baseline characteristics. We conducted this prospective cohort study at 17 CrM FertilityCare(TM) Centers; 16 in the USA and one in Toronto, Canada. Couples who were new or returning users of the CrM were eligible. Couples who were initially trying to conceive or had a history of subfertility were excluded. Couples were enrolled and followed prospectively by their CrM instructors and also by CEIBA study staff. They completed baseline questionnaires. 1,132 new couples were assessed; 1,090 (96%) couples were screened; 429 (39%) couples were eligible; 305 women (71%) and 290 (95%) male partners were enrolled. The majority of women was engaged (39%) or married (51%), college graduates (77%), Caucasian non-Hispanic (80%), and Roman Catholic (80%). The most common reasons for learning CrM (women) were to use a natural method for family planning (91%), for moral/ethical/religious reasons (70%), the lack of side effects (71%), or insight into the menstrual cycle and fertility (62%). Women and men intended to have a mean of three and two additional children, respectively. Of women, 21% intended to have a child within a year and 60% between 1 and 3 years. The mean positive childbearing motivation score was 3.3 for both women and men (range 1-4, with 4 being most positive). Couples beginning use of the CrM to avoid pregnancy have high levels of motivation, desire, and intention for future childbearing. The CEIBA study has prospective measures of desires, intentions, and sexual/fertility behaviors for up to 1 year. We will assess the impact of desires, intentions, and behaviors on the pregnancy rates among these couples.
InfertilityAffordability and AccessFertility TreatmentComparison with ART
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.
To analyze cumulative pregnancy rates of subfertile couples after fertility awareness training. A prospective observational cohort study followed 187 subfertile women, who had received training in self-observation of the fertile phase of the menstrual cycle with the Sensiplan method, for 8 months. The women, aged 21-47 years, had attempted to become pregnant for 3.5 years on average (range 1-8 years) before study entry. Amenorrhea, known tubal occlusion and severe male factor had been excluded. An additional seven women, who had initially been recruited, became pregnant during the cycle immediately this is taken to be the spontaneous pregnancy rate per cycle in the cohort in the absence of fertility awareness training. The cumulative pregnancy rate of subfertile couples after fertility awareness training was 38% (95% CI 27-49%; 58 pregnancies) after eight observation months, which is significantly higher than the estimated basic pregnancy rate of 21.6% in untrained couples in the same cohort. For couples who had been seeking to become pregnant for 1-2 years, the pregnancy rate increased to 56% after 8 months. A female age above 35 (cumulative pregnancy rate 25%, p = 0.06), couples who had attempted to become pregnant for more than 2 years (cumulative pregnancy rate 17%, p < 0.01), all significantly reduce the chances of conceiving naturally at some point. Training women to identify their fertile window in the menstrual cycle seems to be a reasonable first-line therapy in the management of subfertility.
The topic of how the menstrual cycle is a vital sign which could signal pathophysiologic process has received considerable attention in the past decade. The current recommendations of various academic groups will be discussed as well as the FertilityTMM Care method of charting and the Naprotechnology approach to evaluating abnormalities of the menstrual cycle. Two clinical scenarios seen in adolescent medicine, PCOS and AUB, will be analyzed looking at the pathophysiology of these clinical scenarios and their management. The approach will be one that conducts an evaluation to try to find the underlying problem and aims to restore the normal physiology of the menstrual cycle.
The American Academy of Pediatrics, the American College of Obstetrics and Gynecology and the New York Academy of Sciences have published academic statements during the past ten years emphasizing the need for providers to teach patients how to chart and the important clinical ramifications of using this charting as a vital sign. In 2006 the American Academy of Pediatrics published in the Pediatrics Journal a "Menstruation Using the Menstrual Sign as a Vital Sign." In 2015, the American College of Obstetrics and Gynecology published a Committee Opinion emphasizing the need to teach women the charting of their menses and the important pathophysiologic process that could be detected with the charting.
RRM MethodsClinical OutcomesClinical ApplicationProfessional Training
Fehring RJ et al., 2016·MCN Am J Matern Child Nurs
The aims of this study were to determine and compare extended use-effectiveness of an online nurse-managed fertility education service program among women (and subgroups of women) seeking to avoid pregnancy. This was a 24-month prospective study of a university-based online Web site with 663 nonbreastfeeding women using an online charting system to avoid pregnancy. Participants tracked their fertility online with either cervical mucus monitoring, electronic hormonal fertility monitoring, or both fertility indicators. Unintended pregnancies were validated by professional nurses. Participants had a mean age of 30.4 years (SD = 6.3) and mean 1.7 children (SD = 2.0). Among the 663 nonbreastfeeding participants there were 2 unintended pregnancies per 100 at 24 cycles of correct use and 15 pregnancies at 24 cycles of typical use. However, the 212 women using the electronic fertility monitor had a typical use unintended pregnancy rate of 6 at 24 cycles of use in comparison with the 118 women using cervical mucus monitoring that had a typical use pregnancy rate of 19 at 24 cycles and with the 333 women using both fertility indicators that had a pregnancy rate of 18 at 24 cycles of use. Use of the fertility monitor to estimate fertility among nonbreastfeeding women provides the most secure method of avoiding pregnancy.
Various fertility indicators are used by natural family planning methods to identify the fertile and infertile phases of a woman's mucus observations, cycle-day probabilities, basal body temperature readings, and hormonal measures of LH and estrogen. Simplified NFP methods generally make use of a single fertility indicator such as cycle-day probabilities (Standard Days Method) or mucus observations (Billings Ovulation Method). The Couple Bead Method integrates the two simplest fertility indicators, cycle-day probabilities and mucus observations, expanding its applicability to all women, regardless of cycle regularity and length. In determining cycle-day probabilities, the Couple Bead Method relies on a new data set from ultrasound-derived determinants of gestational age that more directly define the day of conception and the fertile window. By using a visual-based system of inexpensive colored beads, the Couple Bead Method can be used by couples of all educational and income levels. Natural family planning methods provide education in regard to the signs of a woman's body which indicate if she is possibly fertile or not. Two important signs are the day of her menstrual cycle and her observations of bleeding and cervical mucus or dryness. The Couple Bead Method teaches a couple how to observe these signs and chart them with a system of colored beads. The Couple Bead Method can be used by women with regular or irregular cycles. The bead sets are inexpensive and consist of a length of plastic cord, colored "pony beads" and safety pins.
NaProTECHNOLOGYInfertility TreatmentDeveloping Countries
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.
SurgeryTubal Repair vs IVFTreatment OptionsFallopian Tube Restoration
American Society for Reproductive Medicine, 2015·Fertil Steril
This document reviews surgical options for achieving patency in obstructed fallopian tubes and the factors that must be considered when deciding between surgical repair and IVF. This document replaces the document of the same name, last published in 2012 (Fertil Steril 2012;97:539–45).
Luteal phase deficiency (LPD), while commonly observed and managed in stimulated in-vitro fertilisation cycles, is a more contentious phenomenon in natural cycles. The challenge arises in the definition and diagnosis of LPD. Controversy regarding the clinical significance of LPD is due in part to the lack of a reliable test to diagnose the disorder.2 Jones first described LPD based on temperature criteria, urinary pregnanediol studies and histological appearance of the endometrium in 1949. 3 In current practice, timing of the luteal phase from which an evaluation of its length and hormonal parameters can be made are problematic. Ovulation and thereby the length of the luteal phase can reliably and reproducibly be determined by teaching women to identify their Peak Symptom Day (PSD) of cervical mucus (the last day of any mucus discharge that is clear, stretchy, or lubricative). 4 There is an abrupt and dramatic change in the characteristic fertile pattern of pre-ovulatory mucus that is due to the effects of progesterone post-ovulation. Correlation with ultrasound and hormonal evaluation indicates that the mucus observation occurs within 2 days of ovulation. Using such a fertility awareness based method, the American Academy of Fertility Care Professionals has defined a luteal phase deficiency as a deficiency in the length of the luteal phase, or a deficiency of the hormones progesterone and oestradiol that occurs during the luteal phase. Women presenting with infertility or recurrent miscarriages to the Fertility Assessment and Research Clinic of the Mater Mothers' Hospital (Brisbane, Australia) were instructed in the Sympto-Thermal Method. This allowed for accurate documentation of ovulation and the luteal phase. Luteal phase hormone levels were collected 5, 7 and 9 days after ovulation. Women were allocated a luteal phase status using the definition below for luteal phase defect. This data is part of the recruitment phase of the Pregnancy Achieving Trials (Mater Health Services HREC no. 1618M). By the definition above, a luteal phase deficiency exists in 36% (100) of 279 infertile couples who presented to our clinic, in preparation for involvement in the Pregnancy Achieving Trials. Of 16 infertile women who had previously experienced both a miscarriage and an ectopic pregnancy, 75% (12) met the criteria for a luteal phase deficiency. Ectopic pregnancy is known to be associated with infectious history, smoking, age, previous spontaneous miscarriage, history of infertility, previous use of an intrauterine device and prior history of medical termination of pregnancy (mifepristone + misoprostol). Previous research has suggested an association between luteal phase defect (LPD) and ectopic pregnancy in subfertile couples." All stimulated cycles of in-vitro fertilisation have abnormal luteal phases.' There exists a high rate of ectopic pregnancy among women undergoing in-vitro fertilization. The high proportion of ectopic pregnancies among women who fall pregnant on progestogen-only contraceptives also suggests an hormonal association." Women who are heavy smokers, another risk factor associated with ectopic pregnancy, has been shown to have lower urinary progesterone metabolite levels in the luteal phase compared with non-smokers. 10 There appears to be an association between prior miscarriage, prior ectopic pregnancy and luteal phase deficiency in subfertile couples. Could luteal phase deficiency, an hormonal disorder, be useful in the definition of ectopic pregnancy risk?
Fehring RJ et al., 2013·MCN Am J Matern Child Nurs
To determine the influence of mutual motivation on unintended pregnancy rates of couples who used natural family planning (NFP) methods to avoid pregnancy. Using an online taught NFP method, 358 women and (their male partners) indicated "how much" and "how hard" they wished to avoid pregnancy on a scale of 0 to 10 before each menstrual cycle charted over 12 month of use. This motivation scale is used in the National Survey of Family Growth as a measure of motivation. All pregnancies were verified with an online pregnancy evaluation and urine-based pregnancy test. A combined motivation score was used in analysis. There were 28 pregnancies among the low-motivation participants (N = 60) and 16 among the high-motivation participants (N = 298). At 12 months of use, there were 75 pregnancies per 100 users for the low-motivation group and only 8 for the high-motivation group. There was an 80% greater likelihood of a pregnancy with the low-motivation group (χ = 25.5, p < .001, odds ratio = 1.80; 95% confidence interval = 1.61-1.90).
High motivation to avoid pregnancy by both the female user of a behavioral method of family planning and her male partner is required for high efficacy. Assessing motivation of both the woman and her male partner before prescribing NFP methods is recommended.
Body LiteracyClinician Training and PerspectivesTitle X Clinic ImplementationProvider Barriers and Facilitators
Natural family planning (NFP) methods are effective for contraception with proper and consistent use. However, only 1% of patients at federally funded Title X family planning clinics select NFP as a contraceptive method. The goal of this study was to understand from clinicians' perspectives the barriers and facilitators to providing NFP methods. Six telephone focus groups were conducted with 29 clinicians from Title X clinics across the United States and Puerto Rico. A hermeneutic method was used to analyze data for related themes. The overarching theme from the study was that participants had a strong desire to teach their patients how their bodies work and to empower them to learn to control fertility. patient misinformation and misunderstanding about fertility; provider ideas about ideal types of candidates for NFP; inconsistent patient teaching strategies; and lack of time to teach NFP methods. There is a need for increased NFP training for providers and efficient NFP patient teaching strategies to meet the needs of patients with limited knowledge about fertility.
SurgeryTechniques and OutcomesSurgical TreatmentTubal Reconstruction
The diminished role of tubal surgery in infertile women following widespread access to IVF is now being reviewed as more patients and surgeons today consider tubal surgery as an effective alternative to assisted reproduction treatment in certain circumstances. The limitations of and lack of patient acceptance of assisted reproduction treatment for ethical and moral reasons have contributed to this change as well as advances in surgical techniques and instrument technology, notably developments in endoscopic surgery. Strategies in tubal surgery are largely unchanged but the mini-invasive nature of the endoscopic approach has added value because of less tissue trauma, better visualization of the operative field and more rapid healing, which make surgery using today's techniques an integral part of the treatment strategy in infertile couples.
Fehring RJ et al., 2011·J Obstet Gynecol Neonatal Nurs
To evaluate the efficacy, knowledge of fertility, and acceptability of a web-based natural family planning (NFP) education and service program.
A 6-month repeated measure longitudinal evaluation pilot study.
A university based online website. The website was piloted with 468 volunteer women seeking NFP services. Of these participants, 222 used the automatic online fertility charting system to avoid pregnancy. The 222 charting participants had a mean age of 29.9 years (SD=5.6), 2.2 children (SD=1.9), 37% were postpartum, and 47% had regular menstrual cycle lengths. Nurse-managed web-based NFP education and service program. Pregnancies were confirmed by an online self-assessed pregnancy evaluation form. A 10-item fertility quiz and 10-item acceptability survey was administered online. Among the 222 users avoiding pregnancy, at 6 months of use, there were two correct-use unintended pregnancies that provided a pregnancy rate of 2% and seven total unintended pregnancies providing a typical use pregnancy rate of 7%. Mean knowledge of fertility increased significantly from time of registration (8.96, SD=1.10) to 1 month of use (9.46, SD=.10), t=4.60, p<.001). Acceptability increased nonsignificantly from 1 month of use (45.6; SD=8.98) to 6 months of use (48.4; SD=8.77). The nurse-managed online NFP system seems to provide adequate knowledge of fertility and help participants meet pregnancy intentions. Acceptability of such a system of NFP is still in question.
Boyle PC et al., 2011·Biomedicina (Sveikatos Mokslai/Health Sciences)
Infertility is usually a consequence of multiple chronic conditions rather than a single acute condition. We propose that it is erroneous to apply acute medical interventions to a condition that is chronic in nature.
Retrospective analysis of 3 case studies which demonstrate the multifactorial and chronic nature of infertility that were previously managed unsuccessfully with acute intervention using IVF (in Vitro Fertilisation) or ART (Assisted Reproductive Technology).
Demonstration of the multifactorial approach and 3 successful singleton live births using NPT (Natural Procreative Technology or NaProTechnology). Infertility can be treated successfully with a multifactorial approach which takes into account the chronic nature of infertility and targets treatment to manage multiple factors responsible for the condition. Infertility is not a diagnosis but is often the expression of several underlying ill health conditions which if diagnosed and treated correctly will result in restoration of normal reproductive function. Physicians ought to consider broader diagnostic possibilities in their evaluation of infertile couples. A multifactorial treatment strategy for the chronic condition of infertility may be more effective than the widespread acute strategy employed by ART. Further study is required to investigate this possibility in more detail. Future studies looking at NPT and ART outcomes must be cohort studies comparing populations with similar patient characteristics.
Fertility AwarenessNFP Efficacy and EffectivenessCatholic Healthcare IntegrationBarriers and Adoption
Relatively few Catholic couples in the United States use modern methods of natural family planning (NFP). So too, few Catholic physicians and health professionals prescribe the use of NFP methods for their patients. Reasons for low use of NFP methods include their perceived low efficacy; the complexity of learning, using, and teaching these methods; and the prolonged (and often unnecessary) required abstinence. Newer and simplified methods of NFP have been developed by physicians and scientists that are less complex and use modern technologies of detecting fertility and communicating instructions. Catholic physicians and scientists need to continue to answer the call by the Holy Fathers (from Pius XII to Benedict XVI) to develop secure and scientifically sound methods of NFP.
Fehring RJ et al., 2008·MCN Am J Matern Child Nurs
To determine the effectiveness of the Marquette Method (MM) of natural family planning (NFP) as a method of avoiding pregnancy. This was a 12-month retrospective evaluation of the MM system of NFP. Two hundred and four women (mean age, 28.6 years) and their male partners (mean age, 30.3 years) who sought to learn a method for avoiding pregnancy with the MM from four clinical sites were taught to track their fertility by self-observation of cervical mucus, by use of an electronic monitor that measures urinary levels of estrone-3-glucuronide and luteinizing hormone, and by use of basal body temperature. All unintended pregnancies were evaluated by professional nurses as to whether they were intended or not. Pregnancy rates over 12 months of use were determined by survival analysis. There were a total of 12 unintended pregnancies, only 1 with correct use. The 12-month "correct use" pregnancy rate was 0.6 (i.e., 99.4% effective) and the "typical use" (total pregnancy rate) was 10.6 (i.e., 89.4% effective) per 100 users.
When used correctly, the MM system of NFP is an effective means of avoiding pregnancy. The efficacy of the MM system includes proper preparation of the professional nurse NFP teachers.
Fertility AwarenessScientific EvidenceNatural Family PlanningResearch Overview
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.
Body LiteracyProfessional Training ProgramsHealthcare Provider EducationDistance Education
Nurses and other health care professionals often have little knowledge of methods of natural family planning (NFP) and do not readily prescribe natural methods for their patients. One reason for this is that little or no information on NFP is provided in nursing or medical schools. The holistic, informational, and integrative nature of NFP fits well with professional nursing practice. A university online distance education NFP teacher training program, which offers academic credit and includes theory, practice, and the latest developments in fertility monitoring, has been developed for health care professionals. Professional NFP services in the United States need to meet worldwide standards and include documenting and assessing pregnancy outcomes, tailoring NFP services to the client or couple, and simplifying them for ease of use in a standard health care practice.
The purpose of this study was to evaluate the effect of prophylactic vaginal progesterone in decreasing preterm birth rate in a high-risk population. A randomized, double-blind, placebo-controlled study included 142 high-risk singleton pregnancies. Progesterone (100 mg) or placebo was administered daily by vaginal suppository and all patients underwent uterine contraction monitoring with an external tocodynamometer once a week for 60 minutes, between 24 and 34 weeks of gestation. Progesterone (n = 72) and placebo (n = 70) groups were compared for epidemiologic characteristics, uterine contraction frequency, and incidence of preterm birth. Data were compared by chi(2) analysis and Fisher exact test. The preterm birth rate was 21.1% (30/142). Differences in uterine activity were found between the progesterone and placebo groups (23.6% vs 54.3%, respectively; P <.05) and in preterm birth between progesterone and placebo (13.8% vs 28.5%, respectively; P <.05). More women were delivered before 34 weeks in the placebo group (18.5%) than in the progesterone group (2.7%) (P <.05). Prophylactic vaginal progesterone reduced the frequency of uterine contractions and the rate of preterm delivery in women at high risk for prematurity.
In an otherwise excellent editorial that appeared in this journal concerning the problems created by failure of the Health Insurance Industry to provide coverage for infertility, the author, a noted academician and clinician, repeatedly referred to infertility as a disease (1). The mistaken idea that infertility is a disease is commonplace among not only academicians and clinicians but also among third-party payers and the general public and is one of the reasons that infertility is not covered by most insurance plans.
The facts are that infertility and its frequent companion, anovulation, are not diseases; they are symptoms of underlying, sometimes serious disease in one or both marital partners. One result of considering infertility and anovulation as diseases rather than as symptoms is that unnecessarily powerful and expensive treatments may be used to obtain an immediate pregnancy, whereas chronic disease that may affect lifelong health is overlooked.
Just as the symptoms chronic headache, chronic stomach pain, and chronic chest pain may be caused by underlying disease, so may infertility be caused by underlying disease. Endometriosis, uterine fibroids, benign ovarian tumors, and pelvic adhesive disease are causes of infertility that can be treated by laparoscopy, if detected early, but may require more extensive surgery later if they remain undiagnosed. Anovulation may be due to insulin resistance that can result in diabetes or cardiovascular disease later in life (2) or any of a number of other endocrine disorders with lifelong effects.
A 1991 study from the Centers for Disease Control and prevention (CDC) found that the lifetime risk of developing endometrial cancer was increased not only in patients with polycystic ovary syndrome but also in infertile patients with hypothyroidism, uterine fibroids, and endometriosis (3). Infertile women with any of these conditions who conceived a term pregnancy did not have an increased risk of endometrial cancer.
A major obstacle to the treatment of infertility as a symptom by the Health Insurance Industry is the way it is characterized in the International Classification of Diseases, Volume 9 (ICD). In the ICD, female infertility (Code 628.0) and male infertility (606.0) are classified as diseases but are clearly treated as symptoms. Female infertility is listed as “associated with,” “due to,” or “having its origin in” 30 other conditions. Similarly, male infertility is listed as “due to” 12 other conditions. Anovulation is given the same diagnostic code number as female infertility (628.0) and is not classified further as to its underlying causes. Health insurers have taken advantage of this to deny coverage for endocrine evaluation of patients with anovulation on the basis that it is synonymous with infertility.
The ICD needs to be revised according to modern understanding of anovulation and the causes of female and male infertility, as was done in the 1999 edition for complications of pregnancy and childbirth. Health insurers must acknowledge that anovulation is a symptom separate from infertility that requires diagnosis and treatment irrespective of a desire to become pregnant. All of us, practicing physicians and academicians, should make establishment of an accurate and complete diagnosis our first goal when presented with an infertile couple.
de Leizaola MA, 1998·J Gynecol Obstet Biol Reprod (Paris)
A Belgian pilot-study conducted in the framework of the prospective European multi-center study (University of Düsseldorf) tried to establish the use-effectiveness (a sine qua non condition for its acceptance in Europe) of natural family planning. 84 participants provided data (sympto-thermal chart and related information) on 1,750 cycles where family planning intention was to avoid a pregnancy. The average age of the women was 32 years. A contraceptive method (mainly oral contraceptives) was employed previously by 61% of them. The sympto-thermal method used by the test group highlights the beginning and the end of the menstrual cycle's fertile period by a double check. As to the start of the fertile period, a calculation on the length of the previous twelve cycles and the first sign of mucus at either the vulva or the cervix. Indicators the third day of high temperature and the fourth evening after either the peak mucus day or the peak cervix day. 75% of the women involved generally use the cervical auto-palpation. No method failure at all has been detected. Two unplanned pregnancies occurred due to user failure. The total Pearl index for the study was 1.4. When examining only those cycles (85% of the reported cycles) where no protected sexual intercourse occurred during the fertile phase, practical efficacy of the method analysed was 1.8 according to Pearl index. Furthermore, taking into account protected and unprotected sexual intercourse occurred during the fertile phase, we observed that sexual abstinence was practised during the "risk" period of 75% of the cycles. The results of this test study demonstrate the practical efficiency of a modern natural family planning method. The high level of cycles during which periodic abstinence was employed testify to the acceptability of the method used.
To verify the occurrence of preferential distribution of vaginally administered progesterone to the uterus compared with extrapelvic regions in vivo and in humans. Prospective clinical study. University medical school. PATIENT(S): Twenty postmenopausal women undergoing transabdominal hysterectomy for benign pathologies. INTERVENTION(S): Forty-five minutes before surgery, the women received a single vaginal administration of an oil-based micronized progesterone (100 mg) solution currently available on the market for IM use. During the operation, parallel blood samples were drawn from the uterine and radial arteries. MAIN OUTCOME MEASURE(S): Plasma levels of progesterone were measured by RIA. RESULT(S): Mean (+/- SD) plasma levels of progesterone were significantly higher in the uterine artery than in the radial artery (9.75 +/- 3.21 vs. 5.12 +/- 2.06 ng/mL, respectively). CONCLUSION(S): Vaginal administration allows a preferential distribution of progesterone to the uterus, which confirms the existence of the so-called "first uterine pass effect."
Patients suffering from normogonadotrophic anovulation and infertility are initially treated with clomiphene citrate. Those who do not respond to clomiphene citrate usually receive gonadotrophin treatment which is labour-intensive, expensive, and associated with an increased risk of multiple pregnancies and ovarian hyperstimulation syndrome. We treated 22 patients with clomiphene resistant normogonadotrophic anovulation with naltrexone (an opioid receptor blocker) alone or naltrexone in combination with an antioestrogen. In 19 patients ovulation and resumption of a regular menstrual cycle was achieved and in 12 out of 19 a singleton pregnancy was observed. In conclusion, ovulation can be induced successfully using naltrexone alone or naltrexone in combination with an anti-oestrogen in clomiphene citrate resistant anovulatory patients. Compared to gonadotrophin induction of ovulation, this method is safe, simple and inexpensive.
Fertility AwarenessProvider Perspectives and BarriersNFP in Family PlanningNFP Service Expansion
Despite the recognized benefits for clients and programs of providing natural family planning (NFP) services, few family planning programs offer NFP and few provide fertility awareness education. Furthermore, many non-governmental organizations (NGOs) that provide only NFP actually reach a very small percentage of the potential NFP users in the areas they serve. This paper discusses the results of interviews with selected family planning providers that were conducted to explore reasons why NFP and fertility awareness education are not offered in their programs, and with NFP providers to get their opinions on how to improve service delivery. The interviews were structured around some of the lessons learned from the successful incorporation of the lactational amenorrhea method (LAM) into several multimethod family planning programs. There is agreement that the need for NFP services* is far from being met and that most clients lack the information and skills they could learn through fertility awareness education. The providers interviewed also acknowledged that offering these services would improve the quality of reproductive health services in general. Presented here are some ideas about why these services are not offered, as well as suggestions for integrating NFP and fertility awareness education into existing family planning programs.
Fertility AwarenessCalendar-Based MethodsPilot StudiesStandard Days Method
Natural methods of fertility regulation are acceptable in most cultures. Many couples worldwide do not wish to use contraceptives or do not have access to them but wish to limit their family size or lengthen the time between births. Barriers to expanding use of natural family planning (NFP) methods include a lack of providers who can teach NFP and a lack of time to teach and follow couples during the initial months of NFP use. If simple yet effective methods of NFP are available, then NFP could be introduced to a wider audience. Recently, calendar rules have been revised that use a set interval to identify fertile days. These new rules provide better coverage of fertile days and require less abstinence than the rules traditionally used with the calendar method. One of these new rules is being field tested in a pilot study in Brazil. Couples are asked to abstain from day 9-19 (inclusive) of the menstrual cycle, using a beaded necklace (the 'collar') as a mnemonic device. Focus groups with the teacher-monitors and in-depth interviews with female and male users were carried out to evaluate the acceptability of the 'collar' method. A preliminary analysis of these focus groups and interviews from the first site is presented.
Menstrual CycleHypothalamic Amenorrhea TreatmentOpioid Antagonist TherapyNaltrexone for Amenorrhea
To evaluate whether the efficacy of naltrexone administration in patients with hypothalamic amenorrhea correlates to the response to an acute naloxone test.
Thirty patients with hypothalamic amenorrhea associated with weight loss were studied. After naloxone test (4 mg in bolus IV) patients group A, nonresponsive (n = 15) and group B, responsive (n = 15). Group A underwent two cycles of hormonal replacement therapy with E2 patches and medroxyprogesterone acetate. Then all patients were administered naltrexone at the dosage 50 mg/d orally for 6 months. A third group of 10 amenorrheic patients were treated with oral placebo with the same schedule. Plasma gonadal steroid levels increased in all patients and in 24 of 30 patients the menstrual bleeding occurred within 90 days from the beginning of treatment. After 6 months from naltrexone discontinuation, 18 of 24 patients still showed the occurrence of menstrual cycles. Luteinizing hormone plasma levels and LH pulse amplitude increased after 3 months of treatment and remained unchanged 6 months after naltrexone suspension. Plasma FSH levels did not show any change in any patient. The body mass index increased after 3 months in all patients who menstruated. Patients treated with placebo did not show any significant change in gonadotropins and gonadal steroid plasma levels. The present study supports the efficacy of naltrexone therapy for patients with hypothalamic amenorrhea either responsive or nonresponsive to naloxone test.
Vaginal progesterone suppositories are an accepted treatment for infertility attributed to luteal phase defects. Although oral micronized progesterone may be preferable to suppositories for many patients, there are no studies on its use for patients with luteal phase defects. This study evaluated the efficacy of oral micronized progesterone for the treatment of luteal phase defects. Seven women with luteal phase defects previously corrected by vaginal suppositories were administered oral micronized progesterone (200 mg by mouth three times a day). Endometrial biopsies were performed to evaluate treatment efficacy. Questionnaires were used to assess side effects, including sedation. On oral micronized progesterone, all patients had in-phase endometrial biopsies. Despite complaints of drowsiness, the majority of patients preferred the oral formulation over the vaginal route of administration. We conclude that oral micronized progesterone is efficacious in the treatment of luteal phase defects.
good of all, and above all, for the protection of the weak."2I submit that, no matter how appealing a marketplace model may seem for the NHS, it is a business model.As such the destruction of either purchaser or provider is eventually certain, with the barbarisation of the survivor.It is not too late for consortiums of purchasers and consortiums of providers to join forces and become one NHS again.
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.
An improved delivery method to achieve sustained physiological P levels would be useful. Based on this single-dose pharmacokinetic study, micronized P prepared in a nonliquefying vaginal cream holds promise as a convenient method to achieve this goal with a single daily application.
Fertility AwarenessOverviewClinical ReviewPrimary Care
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 deficiency in follicle stimulating hormone (FSH) levels during the early follicular phase of the menstrual cycle has been shown to result in luteal phase defect (LPD). A short course of human urinary FSH (uFSH) (Metrodin, Serono Laboratories) was given for a maximum of six cycles to 18 women with endometrial-biopsy-proven (EBX-proven) LPD. Adjunctive therapy in the form of midcycle human chorionic gonadotropin was given after the third therapy cycle. The uFSH therapy reduced the mean EBX lag time (2.0 +/- 0.6 days with therapy vs. 4.1 +/- 0.4 pretherapy, P less than .01), normalized the follicular phase length (15 +/- 0.4 days vs. 17.2 +/- 0.8 pretherapy, P less than .25) and increased the luteal phase length (12.7 +/- 0.4 days vs. 10.8 +/- 0.2 pretherapy, P less than .001). Twelve of 46 cycles (26%) in which uFSH was given without adjunctive therapy were anovulatory. Seven patients conceived; the result was seven viable pregnancies, all delivered at term. The cumulative pregnancy rate approached 48% by the sixth therapy cycle. uFSH therapy is useful for the correction of LPD and yields an acceptable pregnancy rate.
The bioavailability of micronized progesterone (P) was studied by measuring sequential serum P concentrations after a single bolus of 50-200 mg P given sublingually, orally (capsule and tablet), vaginally and rectally (suppositories) during the follicular phase in a group of normally menstruating women. When compared to other modes of P administration, the area under the curve during the first eight hours was twice as high with the rectal route. With 50 and 100 mg P given sublingually and 100 and 200 mg ingested as tablets, peak levels and area under the curve were twice as high with the higher dosage. The response was more sustained with the higher dosage. All subjects exhibited a significant increase in serum P levels over baseline that persisted for at least eight hours. P levels were still increased over baseline at 24 hours in all subjects after the administration of 100-mg vaginal and rectal suppositories and 200-mg tablets. These findings are in general agreement with previous reports showing that luteal phase serum P concentrations can be reached easily with non-parenteral modes of administering micronized P and that oral P administration could become an attractive alternative to the currently used oral mode of administering synthetic progestins.
A study was designed to see if the use of prophylactic progesterone vaginal suppositories (PVS) reduced the risk of spontaneous abortions in women with a history of at least one spontaneous abortion. PVS was employed during the luteal phase to the end of the first trimester. The dosage was initially 50 mg/day, but was increased according to the endometrial biopsy and doubled as soon as pregnancy was established. Only 10 women (10%) aborted, and 8 of these 10 were successful in their next PVS-treated pregnancies. Overall there were 12 losses in 132 pregnancies (9%) in these PVS-treated patients. Forty-two percent of untreated controls aborted (10/24). The results suggest that PVS is effective in reducing the risk of spontaneous abortions in high-risk patients.
NaProTECHNOLOGYProfessional TrainingNFP EducationService Development
There is no information available about the effect of iron in formula on the development of gastrointestinal humoral immune response in early human infancy. We compared standard Enfamil to iron-fortified formula during the first 8 weeks of human life on the development of local gastrointestinal humoral immune response by measuring fecal secretory immunoglobulin A (SIgA). Thirty children were studied and classified according plain Enfamil (n = 15) and Enfamil with iron (n = 15). Fecal specimens were analyzed at birth, 2 weeks, 4 weeks, and 8 weeks of age. Fecal SIgA was assayed by RID (radial-immune diffusion) during these four infantile periods in the two groups. Marked SIgA changes were detected in the group with iron-fortified formula versus non-iron-fortified formula. These changes appeared to have statistical significance in all the three infantile periods (2 weeks, 4 weeks, and 8 weeks). There were no observed clinical side effects with the use of iron-fortified formula as detected by appropriate questionnaire. The possible role of iron in earlier and enhanced development of immunologic competence and host defense is discussed. These data may suggest a beneficial effect of low-dose iron in formula during early infantile human life by the protective role of the earlier and enhanced production of SIgA in the gut.
Menstrual CycleCervical MucusClinical OutcomesProfessional Training
Leyendecker G et al., 1980·J Clin Endocrinol Metab
In previous studies it could be demonstrated that in severe hypothalamic amenorrhea, which is associated with absent or deficient hypothalamic secretion of Gn-RH, ovarian function could be restored by chronic intermittent (pulsatile) administration of Gn-RH. In order to apply chronic intermittent administration of Gn-RH as a new mode of treatment of infertility in hypothalamic amenorrhea on an outpatient basis a portable device ("Zyklomat") was constructed consisting of a peristaltic pump, a computerized timing device and a Gn-RH containing bag, which delivers 50 microliters of a Gn-RH containing solution once every 90 minutes via an i.v. catheter into the circulation. It is the purpose of this communication to present this new method of treatment and the successful induction of the first two pregnancies with this method in two patients with severe hypothalamic amenorrhea.
NFP (natural family planning) has replaced the term of rhythm method in the last decade as a designation for those methods of fertility regulation based on periodic abstinence. A graph presents the symptoms observable during the menstrual cycle and the ways in which these symptoms coincide with the fertile and infertile periods within the cycle. NFP counseling aims at teaching couples how to recognize the beginning and end of the fertile period within the menstrual cycle. Each of the following types of NFP are discussed 1) calendar or calculation method; 2) temperature method; 3) symptothermal methods; and 4) cervical mucus methods. All of these involve detection of the time of ovulation combined with abstinence during the fertile period of the cycle. The symptoms to recognize are taught with each method. Findings from 5 retrospective and 12 prospective studies on the effectiveness of NFP are tabulated. Current research and suggested areas for future research in the field of NFP are mentioned. In the last 20 years, NFP has been popularized through more popular-oriented educational programs. Governments have taken over funding of some NFP programs. Now that NFP effectiveness has been well established, motivation and counseling will be the most important elements in NFP education in the future.
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.