Fertility Awareness-Based Methods for Family Planning: A Literature Review.

A review of 23 research articles to examine fertility awareness-based methods revealed biologic indicators and tracking methods to identify the fertile window in reproductive-aged women. This literature review indicated that a woman's cycle regularity is a major determinant of which method is best. Additionally, the woman's desire to achieve a pregnancy and her preference regarding the intensity of training are factors in method choice. Some evidence suggests that use of at least two biologic indicators is most effective for determining the fertility window. Recommended web and mobile applications also are discussed.

'Innate Nature' and 'Complete Nature': The Catholic Natural Family Planning Program and the Competition of Natural Methods in Mid-1970s Korea.

This article reviews the competition of two natural family planning methods in the mid-1970s when the Catholic Natural Family Planning program was underway in Korea. The Catholic Church, emphasizing the natural law, has recommended Natural Family Planning (NFP), a method of regulating childbirth by abstinence during the fertile period, since the mid-twentieth century. However, a group of gynecologists working at St. Mary's Hospital, a Catholic general hospital in Korea, questioned the utility of NFP. As an alternative, they proposed the method of Ovulation Regulation (OR), which regulates the menstrual cycle by inducing ovulation with steroids agents. This seemed to be no different than contraception with oral contraceptives disapproved of by the Catholic Church, but many doctors who advocated OR thought that this could be a new 'natural' family planning method to replace NFP. What is noteworthy here is the fact that not only NFP advocates, but also OR advocates attempted to justify their methods based on the authority of the 'nature.' In the debate over natural family planning methods, nature's legitimacy was given premise, not the object of doubt. Rather, the issue was the definition of nature. First, 'nature' in NFP signifies 'innate nature,' which excludes human intervention. According to this point of view, OR with steroids agents could not be natural. On the contrary, a group of doctors who advocated OR considered nature 'primal completeness.' If the natural order of the menstrual cycle could be restored, the artificial intervention of the administration of steroids was not a problem. Thus, both groups defended their arguments by redefining nature, rather than raising an issue of nature itself. The competition between 'innate nature' and 'complete nature,' a proxy war between NFP and OR, resulted in the victory of the former as the meaning of nature became fixed. Advocates of NFP pointed out that OR inhibits other physiological functions in the process of inducing ovulation, suggesting that the idea of 'complete nature' could never be achieved. The meaning of nature could no longer be controversial. Since the intervention was unnatural, nature meant innateness, the absence of intervention. Accordingly, the Catholic Bishops of Korea approved the Billings Method, a kind of the NFP, as the official family planning method, and gynecologists at St. Mary's Hospital of Korea also focused on the development and supplementation of the Billings Method. In short, the debate over the methods of natural family planning in mid1970s Korea was a clash of 'innate nature' and 'complete nature.' As a result, this confirmed the limitations of medical practice and reconfirmed the power of magisterium, the church's authority over medical practice.

Evaluation of Mobile Applications Intended to Aid in Conception Using a Systematic Review Framework.

Objective: This review identified and evaluated apps intended to aid women in conception that were available across major mobile platforms; secondary objectives were to highlight additional criteria and considerations when evaluating conception-related apps. Data Sources: Apple iTunes and Google Play stores were searched using the keywords conception, fertility, and pregnant. Data Selection: Included apps were as follows: contained in the first 50 search results; presented in English; intended for layperson use; updated July 1, 2018, or after; marketed as a conception aid; and used a defined fertility tracking method. Excluded apps were intended for men only, marketed for contraception only, promoted a single fertility service or branded product, or not found in both app stores. Data Extraction: Apps were evaluated using the adapted APPLICATIONS Scoring System. Two additional criteria were assessed: inclusion of a privacy policy and inclusion of a search function, medical terminology glossary, or Frequently Asked Questions section. Data Synthesis: A total of 300 apps were screened; 7 app pairs were analyzed. Scores ranged from 9 to 13 of a possible 15 points (mean = 11; median = 11). No app reported advisement from a health professional during development. Relevance to Patient Care in Clinical Practice: Widely available apps that score highly per the adapted APPLICATIONS Scoring System may be considered for use by and recommended to women seeking apps useful for conception. Conclusion: Evaluation tools should evolve as app features change. Criteria related to privacy and search functions that promote health literacy should be considered for future app evaluation tools.

Advantages of determining the fertile window with the individualised Natural Cycles algorithm over calendar-based methods.

Purpose: This study aims to compare the accuracy of fertile window identification with the contraceptive app Natural Cycles against the Rhythm Method and Standard Days Method (SDM).Materials and methods: Menstruation dates, basal body temperature (BBT), and luteinising hormone (LH) test results were collected anonymously from Natural Cycles app users. The fraction of green days (GDs) and wrong green days (WGDs) allocated by the various algorithms was determined over 12 cycles. For comparison of Natural Cycles and the Rhythm Method, 26,626 cycles were analysed.Results: Natural Cycles' algorithms allocated 59% GDs (LH, BBT) in cycle 12, while the fraction of WGDs averaged 0.08%. The Rhythm Method requires monitoring of six cycles, resulting in no GDs or WGDs in cycle 1-6. In cycle 7, 49% GDs and 0.26% WGDs were allocated. GDs and WGDs decreased to 43% and 0.08% in cycle 12. The probabilities of WGDs on the day before ovulation with Natural Cycles were 0.31% (BBT) and 0% (LH, BBT), and 0.80% with the Rhythm Method. The probability of WGDs on the day before ovulation was 6.90% with the SDM.Conclusions: This study highlights that individualised algorithms are advantageous for accurate determination of the fertile window and that static algorithms are more likely to fail during the most fertile days.

Mobile technology for family planning.

PURPOSE OF REVIEW: To evaluate the recent literature on mobile health applications available to patients for contraception and abortion care. RECENT FINDINGS: Women are increasingly interested in contraceptive tools utilizing mobile technology, and a majority of women expect them to be science-based. The largest number of available mobile apps supports natural family planning methods, which is recognized as the least effective contraceptive method. Many available apps cannot be relied on for accurate, science-based pregnancy prevention methods. Further, there is a paucity of data regarding use of mobile technology for women seeking or receiving abortion. SUMMARY: Further research is needed to evaluate mobile health apps and how they can best provide patient consumers with accurate, evidence-based information to support the prevention of unintended pregnancy.

Perfect- and typical-use effectiveness of the Dot fertility app over 13 cycles: results from a prospective contraceptive effectiveness trial.

OBJECTIVE: Dynamic Optimal Timing (Dot) is a smartphone application (app) that estimates the menstrual cycle fertile window based on the user's menstrual period start dates. Dot uses machine learning to adapt to cycles over time and informs users of 'low' and 'high' fertility days. We investigated Dot's effectiveness, calculating perfect- and typical-use failure rates. METHODS: This prospective, 13 cycle observational study (ClinicalTrials.gov NCT02833922) followed 718 women who were using Dot to prevent pregnancy. Participants contributed 6616 cycles between February 2017 and October 2018, providing data on menstrual period start dates, daily sexual activity and prospective intent to prevent pregnancy. We determined pregnancy through participant-administered urine pregnancy tests and/or written or verbal confirmation. We calculated perfect- and typical-use failure rates using multi-censoring, single-decrement life-table analysis, and conducted sensitivity, attrition and survival analyses. RESULTS: The perfect-use failure rate was calculated to be 1.0% (95% confidence interval [CI]: 0.9%, 2.9%) and the typical-use failure rate was 5.0% (95% CI: 3.4%, 6.6%) for women aged 18-39 (n = 718). Survival analyses identified no significant differences among age or racial/ethnic groups or women in different types of relationships. Attrition analyses revealed no significant sociodemographic differences, except in age, between women completing 13 cycles and those exiting the study earlier. CONCLUSION: Dot's effectiveness is within the range of other user-initiated contraceptive methods.

Estimating six-cycle efficacy of the Dot app for pregnancy prevention.

OBJECTIVE: To assess six-cycle perfect and typical use efficacy of Dynamic Optimal Timing (Dot), an algorithm-based fertility app that identifies the fertile window of the menstrual cycle using a woman's period start date and provides guidance on when to avoid unprotected sex to prevent pregnancy. STUDY DESIGN: We are conducting a prospective efficacy study following a cohort of women using Dot for up to 13 cycles. Study enrollment and data collection are being conducted digitally within the app and include a daily coital diary, prospective pregnancy intentions and sociodemographic information. We used data from the first six cycles to calculate life-table failure rates. RESULTS: We enrolled 718 women age 18-39 years. Of the 629 women 18-35 years old, 15 women became pregnant during the first six cycles for a typical use failure rate of 3.5% [95% CI 1.7-5.2]. All pregnancies occurred with incorrect use, so we did not calculate a perfect use failure rate. CONCLUSIONS: These findings are promising and suggest that the 13-cycle results will demonstrate high efficacy of Dot. IMPLICATIONS: While final 13-cycle efficacy results are forthcoming, 6-cycle results suggest that Dot's guidance provides women with useful information for preventing pregnancy.

Assessing the Competency and Acceptability of Community Health Worker Provision of Standard Days Method® in Family Planning Services in Gisagara District, Rwanda.

This study assesses the competency and acceptability of community-based provision of Standard Days Method® (SDM) to first-time users in Rwanda. The national strategy equips community health workers (CHWs) to resupply pills, injectables and condoms to existing clients. With the aim of expanding access, SDM provision to first-time users was added to the method mix in Gisagara district and assessed with a 12 month prospective, mixed methods study. Thirty percent of SDM clients had never used a method of family planning and 58 percent had not been using a method for at least three months. Eighty-seven percent of CHWs correctly screened clients to use SDM and 92 percent accurately explained how to use CycleBeads to prevent pregnancy. After being counseled by the CHWs, 89 percent of clients reported knowledge of all key steps required in using SDM to prevent pregnancy. Nearly all SDM clients (99 percent) believed that CHWs were able to counsel them adequately. These results suggest that CHWs were able to offer SDM as part of their family planning responsibilities, and the study adds to the evidence on the role of CHWs in expanding contraceptive access and choice.

Can apps and calendar methods predict ovulation with accuracy?

OBJECTIVE: The accuracy of prediction of ovulation by cycle apps and published calendar methods was determined by comparing to true probability of ovulation. METHODS: A total of 949 volunteers collected urine samples for one entire menstrual cycle. Luteinizing hormone was measured to assign surge day, enabling probability of ovulation to be determined across different cycle lengths. Cycle-tracking apps were downloaded. As none provided their methodology, four published calendar-based methods were also examined: standard days, rhythm, alternative rhythm and simple calendar method. The volunteer ovulation data was applied to the app/calendar methods to determine their accuracy. RESULTS: Mean cycle length was 28 days (range: 23-35); 34% of women believed they had a 28-day cycle, but only 15% did. No LH surge was seen for 99 women. Most likely day of ovulation for a 28-day cycle was day 16 (21%). Accuracy of ovulation prediction was no better than 21% by the apps. The standard days and rhythm methods were most likely to predict ovulation (70% and 89%, respectively) but had very low accuracy. CONCLUSIONS: Ovulation day varies considerably for any given menstrual cycle length, thus it is not possible for calendar/app methods that use cycle-length information alone to accurately predict the day of ovulation. National Clinical Trial Code: NCT01577147. Registry website: www.clinicaltrials.gov .

Finding the Fertile Phase: Low-Cost Luteinizing Hormone Sticks Versus Electronic Fertility Monitor.

PURPOSE: To investigate if generic Wondfo ovulation sticks (WLH) are sufficiently sensitive to the luteinizing hormone (LH) surge in urine when used with the Marquette Fertility Algorithm. The electronic hormonal fertility monitor (EHFM) is highly accurate in detecting the LH surge but cost of the monitor and the accompanying test sticks has increased over the last several years. The EHFM is sensitive to detect the LH surge at 20 milli-international units per milliliter (mIU/mL); the WLH sticks are slightly less sensitive at 25 mIU/mL. STUDY DESIGN AND METHODS: A convenience sample of women using the Marquette Method of Natural Family Planning with the EHFM to avoid pregnancy were recruited (N = 54). Each participant used the EHFM every morning after cycle day 6 and tested morning and evening urine with the WLH stick until the day following detection of the LH surge on the EHFM. RESULTS: Forty-two women provided 219 cycles. Frequency of LH surge detection was 182/219 (83.1%) for EHFM and 203/219 (92.7%) for WLH sticks. Agreement between the EHFM and the WLH on the day of the LH surge was 97.7%. High fertility readings providing a warning of peak fertility at least 5 days before peak was 67% for the WLH; the EHFM was 47.7%. Paired sample correlations for high fertility was .174 (p = .014) and paired sample differences t was -4.729 (p = .000). CLINICAL IMPLICATIONS: The WLH stick is sufficiently sensitive to use in place of the EFHM for determining peak fertility and with the Marquette Fertility algorithm. Even with minimal use, WLH sticks cost about half the price of the monitor strips and provide more flexibility of use. Cost differences increase with the number of sticks used per cycle. Further research with a larger sample is needed to verify results.

Perfect-use and typical-use Pearl Index of a contraceptive mobile app.

OBJECTIVES: The Natural Cycles application is a fertility awareness-based contraceptive method that uses dates of menstruation and basal body temperature to inform couples whether protected intercourse is needed to prevent pregnancies. Our purpose with this study is to investigate the contraceptive efficacy of the mobile application by evaluating the perfect- and typical-use Pearl Index. STUDY DESIGN: In this prospective observational study, 22,785 users of the application logged a total of 18,548 woman-years of data into the application. We used these data to calculate typical- and perfect-use Pearl Indexes, as well as 13-cycle pregnancy rates using life-table analysis. RESULTS: We found a typical-use Pearl Index of 6.9 pregnancies per 100 woman-years [95% confidence interval (CI): 6.5-7.2], corrected to 6.8 (95% CI: 6.4-7.2) when truncating users after 12months. We estimated a 13-cycle typical-use failure rate of 8.3% (95% CI: 7.8-8.9). We found that the perfect-use Pearl Index was 1.0 pregnancy per 100 woman-years (95% CI: 0.5-1.5). Finally, we estimated that the rate of pregnancies from cycles where the application erroneously flagged a fertile day as infertile was 0.5 (95% CI: 0.4-0.7) per 100 woman-years. We estimated a discontinuation rate over 12months of 54%. CONCLUSIONS: This study shows that the efficacy of a contraceptive mobile application is higher than usually reported for traditional fertility awareness-based methods. The application may contribute to reducing the unmet need for contraception. IMPLICATIONS: The measured typical- and perfect-use efficacies of the mobile application Natural Cycles are important parameters for women considering their contraceptive options as well as for the clinicians advising them. The large available data set in this paper allows for future studies on acceptability, for example, by studying the efficacy for different cohorts and geographic regions.

Effectiveness of an Online Natural Family Planning Program for Breastfeeding Women.

OBJECTIVE: To analyze the effectiveness of an online, nurse-managed natural family planning (NFP) program among breastfeeding women and subgroups of these women. DESIGN: Longitudinal comparative cohort study. SETTING: A university-based online NFP education program and menstrual cycle charting system. PARTICIPANTS: Women (N = 816) with a mean age of 30.3 years (standard deviation = 4.5) who registered to use the online NFP system and indicated they were breastfeeding. METHODS: Participants tracked their fertile times with an electronic hormone fertility monitor (EHFM), cervical mucus monitoring, or both. All unintended pregnancies were evaluated by professional nurses. RESULTS: The correct use pregnancy rates were 3 per 100 users over 12 cycles of use, and typical rates were 14 per 100 at 12 cycles of use. At 12 cycles of use, total pregnancy rates were 16 per 100 for electronic hormone fertility monitor users (n = 380), 81 per 100 among mucus-only users (n = 45), and 14 per 100 for electronic hormone fertility monitor plus mucus users (n = 391). CONCLUSION: Use of a nurse-managed online NFP program for women can be effective to help women avoid pregnancy while breastfeeding, especially with correct and consistent use.

Preventing Pregnancy in Kenya Through Distribution and Use of the CycleBeads Mobile Application.

CONTEXT: Given the proportion of Kenyan women not using hormonal contraceptives, the country appears to have a substantial need for a modern, natural family planning option. The CycleBeads® mobile phone application (app), a digital platform for the Standard Days Method® of family planning, could help address this issue. METHODS: After the CycleBeads app was promoted in Kenya in May-June 2015, a three-month pilot study was conducted to collect quantitative and qualitative data from 185 female app users. Chi-square testing, binary logistic regression and thematic content analysis were used to assess whether the app brought new users to family planning, to understand users' experiences and to assess how user experiences vary by distribution channel. RESULTS: Participants learned about the app through nongovernmental organizations (17%), via digital media (33%) or from family or friends (50%). Most used the app to track their periods (54%) or prevent pregnancy (37%); a few used it to plan a pregnancy (7%) or for other reasons (2%). The main reason for choosing the Standard Days Method was fear of side effects from hormonal methods (64%). The majority of women found the app and method easy to use (53%). Among those preventing pregnancy, 42% had never before used a method. By midline, all participants knew when fertile days occurred, and most (97%) knew the method's cycle-length requirements. Women reported high rates of condom use (88%), abstinence (68%) and withdrawal (46%) on fertile days. CONCLUSION: Offering the CycleBeads app to support women in use of the Standard Days Method may expand family planning options, reduce unmet need and make family planning more widely available.

The Performance of Fertility Awareness-based Method Apps Marketed to Avoid Pregnancy.

INTRODUCTION: In recent years there has been an explosion in the development of medical apps, with more than 40,000 apps now available. Nearly 100 apps allow women to track their fertility and menstrual cycles and can be used to avoid or achieve pregnancy. Apps offer a convenient way to track fertility biomarkers. However, only some use evidence-based fertility awareness-based methods (FABMs), which with ideal use have rates of effectiveness similar to those of commonly used forms of hormonal birth control. Since having a baby or preventing a pregnancy are important responsibilities, it is critical that women and couples have access to reliable, evidence-based apps that allow them to accurately track their fertility. METHODS: We developed a tool to evaluate and rate fertility apps. This tool is specifically designed to help couples avoid pregnancy. RESULTS: Results showed that the majority of fertility apps are not based on evidence-based FABMs or include a disclaimer discouraging use for avoiding pregnancy. However, at least 1 app in each FABM category (except symptohormonal methods) had a perfect score on accuracy. CONCLUSION: Relying solely on an app to use an FABM, without appropriate training in the method, may not be sufficient to prevent pregnancy.

Personalised estimation of a woman's most fertile days.

OBJECTIVES: We propose a new, personalised approach of estimating a woman's most fertile days that only requires recording the first day of menses and can use a smartphone to convey this information to the user so that she can plan or prevent pregnancy. METHODS: We performed a retrospective analysis of two cohort studies (a North Carolina-based study and the Early Pregnancy Study [EPS]) and a prospective multicentre trial (World Health Organization [WHO] study). The North Carolina study consisted of 68 sexually active women with either an intrauterine device or tubal ligation. The EPS comprised 221 women who planned to become pregnant and had no known fertility problems. The WHO study consisted of 706 women from five geographically and culturally diverse settings. Bayesian statistical methods were used to design our proposed method, Dynamic Optimal Timing (DOT). Simulation studies were used to estimate the cumulative pregnancy risk. RESULTS: For the proposed method, simulation analyses indicated a 4.4% cumulative probability of pregnancy over 13 cycles with correct use. After a calibration window, this method flagged between 11 and 13 days when unprotected intercourse should be avoided per cycle. Eligible women should have cycle lengths between 20 and 40 days with a variability range less than or equal to 9 days. CONCLUSIONS: DOT can easily be implemented by computer or smartphone applications, allowing for women to make more informed decisions about their fertility. This approach is already incorporated into a patent-pending system and is available for free download on iPhones and Androids.

The Accuracy of Web Sites and Cellular Phone Applications in Predicting the Fertile Window.

OBJECTIVE: To evaluate the validity of fertility web sites and applications (apps) by comparing the predicted fertile window of these modalities to the actual fertile window of a standard 28-day cycle. METHODS: This was a descriptive study. The top resulting free web sites and electronic apps downloadable to a cellular phone that provide calendars for fertility and ovulation prediction were assessed. Cycles were standardized to 28 days in length, 4 days of menses, and the last menstrual period was set to January 1, 2015. The predicted date of ovulation and fertility window generated were compared with an actual estimated date of ovulation on cycle day 15, January 15, and a fertile window consisting of cycle day 10 to cycle day 15, the day of ovulation plus the preceding 5 cycle days, January 10-15. RESULTS: Data from 20 web sites and 33 apps were collected. Of all the web sites and apps used, one web site and three apps predicted the precise fertile window. CONCLUSION: Web sites and electronic apps used by the general public to predict fertile windows are generally inaccurate, although the clinical effect of this inaccuracy is unknown. Although they all include the most fertile cycle day, the range of the fertility window varies widely. Patients who are trying to conceive with the assistance of calendars generated from web sites and electronic apps should be counseled on the inaccuracy of these modalities.

Evaluation of the effectiveness of selected natural fertility symptoms used for contraception: estimation of the Pearl index of Lady-Comp, Pearly and Daysy cycle computers based on 10 years of observation in the Polish market.

OBJECTIVES: Cycle computers are medical devices which use sophisticated statistical methods in addition to a comprehensive on-board database. Their main function is to precisely indicate the fertile and infertile phases of the menstrual cycle, based on daily basal body temperature measurements. A recent medical research program aimed at evaluating the EFFECTIVENESS of cycle computers for contraceptive purposes was conducted. MATERIAL AND METHODS: This study was conducted between May and June 2016 on 3,450 Polish women. The Polish distributor sent an anonymous questionnaire to the participants. To date, 361 women, representing 17,322 cycles have returned accurately completed questionnaires. RESULTS: In the resultant group only 4 unintended pregnancies were observed, resulting in a Pearl index of 0.4989. This suggests that fewer than 5 in 1000 women, who use a cycle computer correctly over a period of one year, may become pregnant unintentionally. This result is slightly better than the results from 2010, when the Pearl index was 0.64. CONCLUSIONS: The results obtained from the study indicate that the effectiveness of cycle computers for contraceptive purposes is comparable with other methods, such as hormonal contraception, and therefore cycle computers can be recommended for women who either cannot use or do not wish to use traditional contraception. These results confirm the effectiveness of using natural fertility symptoms, such as basal body temperature changes in the context of cycle computer technology for the purposes of contraception.

Transition from the Lactational Amenorrhea Method to other modern family planning methods in rural Bangladesh: barrier analysis and implications for behavior change communication program intervention design.

The timely transition from Lactational Amenorrhea Method (LAM)(2) to another modern family planning method contributes to healthy spacing of pregnancies by increasing the adoption of family planning during the first year postpartum. Yet, literature suggests challenges in completing a timely LAM transition. To guide program implementation in Bangladesh, this study identified factors influencing women's transition decisions. Eighty postpartum women, comprising 40 who transitioned from LAM(3) and 40 who did not,(4) participated. Half of each group participated in in-depth interviews to explore the decision-making process. All participants responded to a "Barrier Analysis" questionnaire to identify differences in eight behavioral determinants. More than half of transitioners switched to another modern method before or within the same month that LAM ended. Of the 18 transitioners who delayed,(5) 15 waited for menses to return. For non-transitioners, key barriers included waiting for menses to return, misconceptions on return to fertility, and perceived lack of familial support. The LAM transition can help women prevent unintended pregnancy during the first year postpartum. Increased emphasis on counseling women about the risk of pregnancy, and misconceptions about personal fertility patterns are critical for facilitating the transition. Strategies should also include interventions that train health workers and improve social support.

Identification and prediction of the fertile window using NaturalCycles.

OBJECTIVES: The aim of the study was to evaluate the ability of a novel web and mobile application to identify a woman's ovulation day and fertile window, in order to use it as a method of natural birth control. METHODS: A retrospective study was performed on 1501 cycles of 317 women aged 18 to 39 years. Women entered their basal body temperatures, ovulation test results and date of menstruation into the application. RESULTS: The mean delay from the first positive ovulation test to the temperature-based estimation of the ovulation day was 1.9 days; the length of the luteal phase varied on average by 1.25 days per user. Only 0.05% of non-fertile days were falsely attributed and found within the fertile window. CONCLUSIONS: The method is effective at identifying a user's ovulation day and fertile window and can therefore be used as a natural method of birth control.