Understanding the perspective of women who use the Billings Ovulation Method®: a focus group study.

BACKGROUND: The Billings Ovulation Method®(the Billings Method) is a fertility awareness-based method (FABM) of family planning that relies on the observation of patterns of fertility and infertility based on vulvar sensations and appearance of discharges. This allows people to choose when to have intercourse, depending on whether they want to avoid or achieve pregnancy. Few studies have documented user experiences with FABMs. METHODS: We conducted four virtual focus groups (FGs) in May and June 2021 with current adult women users of the Billings Method. We asked questions about users' reasons for selecting a FABM and the Billings Method, positive experiences and challenges learning and using the Billings Method, and suggestions for improving the user experience. We performed a content analysis of the transcribed FGs to explore key themes from the discussions. COREQ guidelines were followed. RESULTS: Twenty women between the ages of 23 and 43 participated in the FGs. Reasons women described choosing a FABM included to follow religious beliefs, to avoid side effects of hormonal contraception, and/or to learn more about their bodies. Reasons for selecting the Billings Method included perceiving it as more precise and easier to understand than other FABMs, having a scientific basis, and being recommended by family and friends. Experiences related to learning and using the Billings Method were mainly positive. They included finding the method easy to use and learn, successfully using it to either postpone or achieve a pregnancy and increasing their awareness of their bodies. Challenges for participants included the inherent learning curve for identifying sensations at the vulva and the required periods of abstinence. Participants provided suggestions and recommendations for improving users' experience, including raising awareness of the Billings Method among healthcare providers. CONCLUSIONS: Users of the Billings Method expressed an overall positive experience when learning and using it for family planning and body awareness. Some challenges were identified that offer opportunities to improve how the Billings Method is taught and delivered. These findings can also enhance healthcare providers' interactions with FABM users, including those of the Billings Method.

The performance of a fertility tracking device.

OBJECTIVE: Fertility tracking devices offer women direct-to-user information about their fertility. The objective of this study is to understand how a fertility tracking device algorithm adjusts to changes of the individual menstrual cycle and under different conditions. METHODS: A retrospective analysis was conducted on a cohort of women who were using the device between January 2004 and November 2014. Available temperature and menstruation inputs were processed through the Daysy 1.0.7 firmware to determine fertility outputs. Sensitivity analyses on temperature noise, skipped measurements, and various characteristics were conducted. RESULTS: A cohort of 5328 women from Germany and Switzerland contributed 107,020 cycles. Mean age of the sample was 30.77 [SD 5.1] years, with a BMI of 22.07 kg/m^2 [SD 2.4]. The mean cycle length reported was 29.54 [SD 3.0] days. The majority of women were using the device 80-100% of the time during the cycle (53.1%). For this subset of women, the fertility device identified on average 41.4% [SD 6.4] possibly fertile (red) days, 42.4% [SD 8.7] infertile (green) days and 15.9% [SD 7.3] yellow days. The number of infertile (green) days decreases proportionally to the number of measured days, whereas the number of undefined (yellow) days increases. CONCLUSION: Overall, these results showed that the fertility tracker algorithm was able to distinguish biphasic cycles and provide personalised fertility statuses for users based on daily basal body temperature readings and menstruation data. We identified a direct linear relationship between the number of measurements and output of the fertility tracker.

A Novel Fertility Indicator Equation Using Estradiol Levels for Assessment of Phase of the Menstrual Cycle.

Background and Objectives: Urinary hormone home monitoring assays are now available for fertility awareness methods (FAMs) of family planning, but lack sensitivity and precision in establishing the start of the fertile phase. We hypothesized that with a suitable algorithm, daily serum or blood estradiol (E2) levels could serve as a better analyte to determine the phase of the ovulatory cycle and the fertile start day (FSD). Materials and Methods: Published day-specific serum E2 levels, indexed to the serum luteinizing hormone (LH) peak, were analyzed from three independent laboratories for a threshold for a FSD. A fertility indicator quation (FIE) was discovered and tested with these data and a FSD was determined using the mean or median and variance ranges of the day-specific E2 data. Results: The considerable variance of day-specific serum E2 levels made an absolute serum E2 indicator for phase of cycle problematic. However, a FIE was discovered which maps the day-specific E2 levels of the ovulatory cycle enabling the fertile phase and transition to the luteal phase to be signaled. In this equation, FIE(D) is the value of FIE on day, D, of the cycle and has both a magnitude and sign. The magnitude of FIE(D) is the product of the normalized change in day-specific E2 levels over two consecutive intervals, (D-2, D-1) and (D-1, D), multiplied by 100, and is formulated as: (E2 (on D-1) - E2 (on D-2))/E2 (on D-2) × (E2(on D) - E2 (on D-1))/E2 (on D-1) × 100. The sign of FIE(D) is either + or - or ind (indeterminate) and is assigned on the basis of the direction of this product. Using a FIE threshold of ≥2.5 as the start of the fertile phase, the FSDs were Day -5 or Day -6, with FSD Day -4 for an outlier set of E2 levels. The maximum FIE value ranged 9.5-27.8 and occurred most often on Day -2. An inflection point with a large change in FIE magnitude and change in sign from + to - always occurred at Day 0 for all sets of day-specific E2 data signaling transition to the luteal phase. Conclusions: The fertility indicator equation, a product of two sequential normalized changes in serum E2 levels with a sign indicating confidence in direction of change, is powerful in identifying the fertile phase and subsequent transition to the postovulatory phase and may serve as a useful algorithm for FAMs of family planning.

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.

Improving usability and pregnancy rates of a fertility monitor by an additional mobile application: results of a retrospective efficacy study of Daysy and DaysyView app.

BACKGROUND: Daysy is a fertility monitor that uses the fertility awareness method by tracking and analyzing the individual menstrual cycle. In addition, Daysy can be connected to the application DaysyView to transfer stored personal data from Daysy to a smartphone or tablet (IOS, Android). This combination is interesting because as it is shown in various studies, the use of apps is increasing patients´ focus on their disease or their health behavior. The aim of this study was to investigate if by the additional use of an App and thereby improved usability of the medical device, it is possible to enhance the typical-use related as well as the method-related pregnancy rates. RESULT: In the resultant group of 125 women (2076 cycles in total), 2 women indicated that they had been unintentionally pregnant during the use of the device, giving a typical-use related Pearl-Index of 1.3. Counting only the pregnancies which occurred as a result of unprotected intercourse during the infertile (green) phase, we found 1 pregnancy, giving a method-related Pearl-Index of 0.6. Calculating the pregnancy rate resulting from continuous use and unprotected intercourse exclusively on green days, gives a perfect-use Pearl-Index of 0.8. CONCLUSION: It seems that combining a specific biosensor-embedded device (Daysy), which gives the method a very high repeatable accuracy, and a mobile application (DaysyView) which leads to higher user engagement, results in higher overall usability of the method.

Hormonal Contraception and the Informed Consent.

Since the 1960s, hormonal contraceptives have become the most commonly used method of pregnancy prevention in the United States and the world. Oral contraceptives are used by a large percentage of women, including Christian women. There are known health risks to women demonstrated in research published since Pope Paul VI's prophetic encyclical Humanae vitae in 1968. These risks include venous thrombosis, cardiovascular risks, and an increased risk of cancer. These risks are medically recognized with continued scientific debate on the degree. The risks are significantly increased with preexisting conditions and in certain demographic groups. Discussing known and potential treatment risks is a standard that is both accepted by the medical community and is increasingly expected by patients. This discussion can be accomplished by the mechanism and principle of informed consent. Depending on the circumstances, abstinence or fertility awareness-based methods (FABMs) should be presented to patients. FABMs are licit, safe, and effective methods of pregnancy prevention. Informed consent is the most effective means of providing patients with pertinent information on the significant risks of contraception. SUMMARY: This article discusses the use of the informed consent to provide patients with information on the medical and ethical risks of oral contraceptives. FABMs and abstinence are presented as effective, safe, and licit preferences to oral contraceptives. Discussing known and potential treatment risks is accepted by the medical community and expected by patients (shared decision making). The authors discuss the historical context of Pope Paul VI's encyclical Humanae vitae in relationship to the development and rapid adoption of oral contraceptives.

Factors Used by Mobile Applications to Predict Female Fertility Status and Their Reported Effectiveness: A Scoping Review.

Family planning, whether for pregnancy prevention or conception, is of pivotal importance to women of reproductive age. As hormonally driven methods, such as oral contraceptive pills, are widely used but have numerous side effects, women often seek alternative non-hormonal, non-invasive options, including fertility-tracking mobile applications (apps). However, the effectiveness of these apps as a method of contraception and conception planning has not been extensively vetted. The goal of this scoping review is to identify the various factors used by apps marketed as a method of contraception and/or family planning to predict a woman's fertility status, as well as their documented effectiveness. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines, a literature search was performed in CINAHL, MEDLINE, and Alt HealthWatch databases for articles published between October 1, 2017, and October 4, 2022. Quality assessment of eligible full-text articles was conducted using the Joanna Briggs Institute critical appraisal tools. A total of 629 articles were screened. Overall, 596 articles were excluded and the remaining 33 articles underwent full-text review. Seven articles were included in the final analysis, yielding data on the following five apps: Natural Cycles, Ava Fertility, Clearblue Connected, Ovia Fertility, and Dynamic Optimal Timing (DOT). Data supporting the effectiveness of these apps is limited. All apps provided predictions on fertility status throughout a woman's menstrual cycle using proprietary algorithms, biometric data, and self-reported menstrual cycle data. Further research, particularly independent research following a randomized controlled design, on the efficacy of these apps is needed to produce more robust results.

Fertility awareness-based methods of family planning.

Fertility awareness-based methods (FABMs) of family planning involve monitoring various signs and symptoms of fertility during the menstrual cycle to identify the "fertile window," or the days of the cycle when unprotected intercourse is most likely to result in pregnancy. Signs and symptoms include menstrual cycle length, basal body temperature, urinary hormone measurements, and/or cervical fluid and may be used alone or in combination. Fertility signs reflect both physiological changes during the menstrual cycle and the life cycle of the ovum and sperm. Women learn to observe or measure and interpret these signs according to the instructions of their chosen FABM and avoid unprotected intercourse on fertile days. FABMs are appropriate for those who choose to use them, are able and willing to observe one or more fertility signs, and are in relationships that support the use of a coitus-related method such as a condom or abstaining from intercourse on fertile days.

Medical Students' Knowledge of Fertility Awareness-Based Methods of Family Planning.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.