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.

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.

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.

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.

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.

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.

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.

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.

Natural family planning.

Natural family planning methods provide a unique option for committed couples. Advantages include the lack of medical adverse effects and the opportunity for participants to learn about reproduction. Modern methods of natural family planning involve observation of biologic markers to identify fertile days in a woman's reproductive cycle. The timing of intercourse can be planned to achieve or avoid pregnancy based on the identified fertile period. The current evidence for effectiveness of natural family planning methods is limited to lower-quality clinical trials without control groups. Nevertheless, perfect use of these methods is reported to be at least 95 percent effective in preventing pregnancy. The effectiveness of typical use is 76 percent, which demonstrates that motivation and commitment to the method are essential for success. Depending on the method, couples can learn about natural family planning methods in a single office visit, through online instruction, or from certified instructors.

Female genital cutting and other intra-vaginal practices: implications for TwoDay Method use.

This report examines the implications of female genital cutting and other intra-vaginal practices for offering the TwoDay Method® of family planning.This fertility awareness-based method relies on the identification of cervicovaginal secretions to identify the fertile window. Female genital cutting and traditional vaginal practices, such as the use of desiccants, may affect the presence or absence of secretions and therefore the woman's perception of her fertility. These issues and their implications for service delivery of the method are discussed.

Continued use of the Standard Days Method.

OBJECTIVE: To examine the long-term effectiveness and continuation of the Standard Days Method (SDM)®, a fertility awareness-based method of family planning that identifies Days 8-19 (inclusive) of the cycle as the fertile window. On these days users avoid unprotected sexual intercourse to prevent pregnancy. The method works best for women with cycles that are usually in the range of 26-32 days, which is an important reason for method discontinuation in the first year of use. The authors determine if this continues to be an issue in the second and third years of method use. METHODS: Participants in an earlier efficacy study (478 women in three countries) and method introduction studies (1181 women in four countries) were followed for 2 years beyond the original 1-year study period, to determine their continued use of the method, intended and unintended pregnancies, and reasons for discontinuation. Life-tables were used to approximate typical use pregnancy rates. RESULTS: The method continues to be effective in the second and third years of use, and compares favourably to other user-directed family planning methods. Women with no more than two cycles outside the 26-32-day range within a year are likely to continue having cycles within this range. CONCLUSIONS: Women who complete the first year of SDM use are likely to continue to be able to use the method successfully and effectively. The method presents a viable longer-term option for women who prefer this approach to family planning.

The Standard Days Method: an addition to the arsenal of family planning method choice in Ethiopia.

BACKGROUND AND METHODOLOGY: The Standard Days Method ® (SDM) is a fertility awareness-based method of family planning that helps users to identify the fertile days of the reproductive cycle (Days 8-19). To prevent pregnancy users avoid unprotected sexual intercourse during these days. A cross-sectional community-based study was conducted from December 2007 to June 2008 in four operational areas of Pathfinder International Ethiopia. A total of 184 SDM users were included in the study. Quantitative and qualitative methods of data collection were used. The aim of the study was to examine the experience of introducing the SDM at community level in Ethiopia. RESULTS: Of the 184 participants, 80.4% were still using the SDM at the time of the survey, with 35% having used it for between 6 and 12 months, while 42% had used it for more than a year. The majority (83%) knew that a woman is most likely to conceive halfway through her menstrual cycle, and nearly 91% correctly said that the SDM does not confer protection from sexually transmitted infections/AIDS. A substantial majority (75%) had correctly identified what each colour-coded bead represents in the CycleBeads ®, and an aggregate of 90.5% of women practised all the elements of correct use. DISCUSSION AND CONCLUSIONS: This study demonstrates the importance of the SDM in increasing the availability and accessibility of family planning, and the potential to improve family planning method choice and method mix by expanding use of the SDM.

[Family planning methods based on fertility awareness]. / Métodos de planificación familiar basados en el conocimiento de la fertilidad.

The desire to limit fertility is recognized both by individuals and by nations. The concept of family planning is based on the right of individuals and couples to regulate their fertility and is based in the area of health, human rights and population. Despite the changes in policies and family planning programs worldwide, there are large geographic areas that have not yet met the minimum requirements in this regard, the reasons are multiple, including economic reasons but also ideological or religious. Knowledge on the physiology of the menstrual cycle, specifically ovulation process has been further enhanced due to the advances in reproductive medicine research. The series of events around ovulation are used to detect the "fertile window", this way women will look for the possibility of postponing their pregnancy or actually start looking for it. The aim of this article is to review the current methods of family planning based on fertility awareness, from the historical methods like the core temperature determination and rhythm, to the most popular ones like the Billings ovulation method, the Sympto-thermal method and current methods like the two days, and the standard days method. There are also mentioned methods that require electronic devices or specifically computer designed ones to detect this "window of fertility". The spread and popularity of these methods is low and their knowledge among physicians, including gynecologists, is also quite scarce. The effectiveness of these methods has been difficult to quantify due to the lack of well designed, randomized studies which are affected by small populations of patients using these methods. The publications mention high effectiveness with their proper use, but not with typical use, what indicates the need for increased awareness among medical practitioners and trainers, obtaining a better use and understanding of methods and reducing these discrepancies.

State-of-the-art of non-hormonal methods of contraception: IV. Natural family planning.

Despite the popularity of 'modern' contraceptives, natural family planning (NFP), including fertility awareness-based (FAB) methods and withdrawal, are practised in most countries. Worldwide FAB methods and withdrawal are used, respectively, by about 3.6% and 2.9% of all couples of reproductive age. This article describes the underpinnings of the different NFP methods, their rationales, histories, rules for use, efficacy and in broad categories their prevalence. Pregnancy rates of FAB methods with perfect use have ranged between 0.3 and 5.0 per 100 users per year, but typical use rates rises into the teens or higher. Withdrawal requires the male partner to be aware of his impending climax and to pull out of the vagina before ejaculation. Perfect use and typical pregnancy rates for withdrawal are estimated to be 4 and 27 per 100 per year, respectively. Many couples find NFP in accord with their own beliefs, satisfactory in its effectiveness and useful in planning a desired pregnancy. Many prize their self-control in practising NFP or withdrawal. In our research we used Medline, Popline and the Cochrane Library search engines in English, local institutional libraries, our own files in our native languages, the literature references contained therein, and source recommendations from colleagues.

[Calculation of the Pearl Index of Lady-Comp, Baby-Comp and Pearly cycle computers used as a contraceptive method]. / Indeks Pearl'a komputerów cyklu Lady-Comp, Baby-Comp i Pearly stosowanych jako metoda antykoncepcji.

INTRODUCTION: Lady-Comp, Baby-Comp and Pearly cycle computers are medical devices that use sophisticated statistical gathering methods, as well as a comprehensive database, to precisely determine fertile and infertile phases of a menstrual cycle on the basis of everyday basal body temperature measurements. They have been produced and distributed worldwide by Valley Electronics GmbH (Eschenlohe, Bavaria, Germany) for over 25 years. OBJECTIVES: The aim of the study was to calculate the Pearl Index of cycle computers in order to determine their contraceptive effectiveness. MATERIAL AND METHODS: 510 Polish women, randomly chosen from the database of the distributor, who had been using the device for over one year or during 13 menstrual cycles, received the questionnaire. The Pearl Index was calculated as a quotient of the number of unplanned pregnancies and the total number of cycles during which cycle computers were used and the obtained value was then multiplied by 1300. Statistical methods were applied to analyze data from the questionnaires and to calculate the Pearl Index. Unplanned pregnancy odds ratio for women using additionally condoms during the fertile phase of the cycle was also calculated. RESULTS: 139 properly filled questionnaires were the source of data about 3332 cycles. After the initial analysis, 290 cycles were declined because the respondents had not complied with the computer indications and 1021 cycles were declined because the respondents had been using other contraceptive methods at the same time--no unplanned pregnancy was noted in that group. In the investigated group of 2040 cycles of correct cycle computers use, one unplanned pregnancy was observed. Calculated Pearl Index for this group amounted to 0.64; it means, that less than 7 out of 1000 users of cycle computer as a contraceptive method may become pregnant within one year The odds of pregnancy in women using a cycle computer and condoms on fertile days amounted to 1.035%; it means that 1 out of 100 users of the combined methods may become pregnant within one year. CONCLUSIONS: The Pearl Index value of cycle computers is comparable with the Pearl Index of hormonal contraceptives. Cycle computers offer an effective and drug-free method of contraception to all women who wish to limit interventions in their bodily functions and do not want or cannot use other contraceptive methods.

'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.

Cohort comparison of two fertility awareness methods of family planning.

OBJECTIVE: To determine if an electronic hormonal fertility monitor aided method (EHFM) of family planning is more effective than a cervical mucus only method (CMM) in helping couples to avoid pregnancy. STUDY DESIGN: Six hundred twenty-eight women were taught how to avoid pregnancy with either the EHFM (n=313) or the CMM (n = 315). Both methods involved standardized group teaching and individual follow-up. All pregnancies were reviewed and classified by health professionals. Correct use and total unintended pregnancy rates over 12 months of use were determined by survival analysis. Comparisons of unintended pregnancies between the 2 methods were made by use of the Fisher exact test. RESULTS: There were a total of 28 unintended pregnancies with the EFHM and 41 with the CMM. The 12-month correct use pregnancy rate of the monitor-aided method was 2.0%, and the total pregnancy rate was 12.0%. In comparison, the 12-month correct use pregnancy rate of the CMM was 3.0%, and the total pregnancy rate was 23.0%. There was a significant difference in total pregnancies between the 2 groups (p<0.05). CONCLUSION: EFHM is more effective than CMM. Further research is needed to verify the results.

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.