Abstract STUDY QUESTION To what extent does the use of mobile computing apps to track the menstrual cycle and the fertile window influence fecundability among women trying to conceive? SUMMARY ANSWER After adjusting for potential confounders, use of any of several different apps was associated with increased fecundability ranging from 12% to 20% per cycle of attempt. WHAT IS KNOWN ALREADY Many women are using mobile computing apps to track their menstrual cycle and the fertile window, including while trying to conceive. STUDY DESIGN, SIZE, DURATION The Pregnancy Study Online (PRESTO) is a North American prospective internet-based cohort of women who are aged 21–45 years, trying to conceive and not using contraception or fertility treatment at baseline. PARTICIPANTS/MATERIALS, SETTING, METHODS We restricted the analysis to 8363 women trying to conceive for no more than 6 months at baseline; the women were recruited from June 2013 through May 2019. Women completed questionnaires at baseline and every 2 months for up to 1 year. The main outcome was fecundability, i.e. the per-cycle probability of conception, which we assessed using self-reported data on time to pregnancy (confirmed by positive home pregnancy test) in menstrual cycles. On the baseline and follow-up questionnaires, women reported whether they used mobile computing apps to track their menstrual cycles (‘cycle apps’) and, if so, which one(s). We estimated fecundability ratios (FRs) for the use of cycle apps, adjusted for female age, race/ethnicity, prior pregnancy, BMI, income, current smoking, education, partner education, caffeine intake, use of hormonal contraceptives as the last method of contraception, hours of sleep per night, cycle regularity, use of prenatal supplements, marital status, intercourse frequency and history of subfertility. We also examined the impact of concurrent use of fertility indicators: basal body temperature, cervical fluid, cervix position and/or urine LH. MAIN RESULTS AND THE ROLE OF CHANCE Among 8363 women, 6077 (72.7%) were using one or more cycle apps at baseline. A total of 122 separate apps were reported by women. We designated five of these apps before analysis as more likely to be effective (Clue, Fertility Friend, Glow, Kindara, Ovia; hereafter referred to as ‘selected apps’). The use of any app at baseline was associated with 20% increased fecundability, with little difference between selected apps versus other apps (selected apps FR (95% CI): 1.20 (1.13, 1.28); all other apps 1.21 (1.13, 1.30)). In time-varying analyses, cycle app use was associated with 12–15% increased fecundability (selected apps FR (95% CI): 1.12 (1.04, 1.21); all other apps 1.15 (1.07, 1.24)). When apps were used at baseline with one or more fertility indicators, there was higher fecundability than without fertility indicators (selected apps with indicators FR (95% CI): 1.23 (1.14, 1.34) versus without indicators 1.17 (1.05, 1.30); other apps with indicators 1.30 (1.19, 1.43) versus without indicators 1.16 (1.06, 1.27)). In time-varying analyses, results were similar when stratified by time trying at study entry (<3 vs. 3–6 cycles) or cycle regularity. For use of the selected apps, we observed higher fecundability among women with a history of subfertility: FR 1.33 (1.05–1.67). LIMITATIONS, REASONS FOR CAUTION Neither regularity nor intensity of app use was ascertained. The prospective time-varying assessment of app use was based on questionnaires completed every 2 months, which would not capture more frequent changes. Intercourse frequency was also reported retrospectively and we do not have data on timing of intercourse relative to the fertile window. Although we controlled for a wide range of covariates, we cannot exclude the possibility of residual confounding (e.g. choosing to use an app in this observational study may be a marker for unmeasured health habits promoting fecundability). Half of the women in the study received a free premium subscription for one of the apps (Fertility Friend), which may have increased the overall prevalence of app use in the time-varying analyses, but would not affect app use at baseline. Most women in the study were college educated, which may limit application of results to other populations. WIDER IMPLICATIONS OF THE FINDINGS Use of a cycle app, especially in combination with observation of one or more fertility indicators (basal body temperature, cervical fluid, cervix position and/or urine LH), may increase fecundability (per-cycle pregnancy probability) by about 12–20% for couples trying to conceive. We did not find consistent evidence of improved fecundability resulting from use of one specific app over another. STUDY FUNDING/COMPETING INTEREST(S) This research was supported by grants, R21HD072326 and R01HD086742, from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, USA. In the last 3 years, Dr L.A.W. has served as a fibroid consultant for AbbVie.com. Dr L.A.W. has also received in-kind donations from Sandstone Diagnostics, Swiss Precision Diagnostics, FertilityFriend.com and Kindara.com for primary data collection and participant incentives in the PRESTO cohort. Dr J.B.S. reports personal fees from Swiss Precision Diagnostics, outside the submitted work. The remaining authors have nothing to declare. TRIAL REGISTRATION NUMBER N/A.
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Characterizing physiological and symptomatic variation in menstrual cycles using self-tracked mobile-health data
The menstrual cycle is a key indicator of overall health for women of reproductive age. Previously, menstruation was primarily studied through survey results; however, as menstrual tracking mobile apps become more widely adopted, they provide an increasingly large, content-rich source of menstrual health experiences and behaviors over time. By exploring a database of user-tracked observations from the Clue app by BioWink GmbH of over 378,000 users and 4.9 million natural cycles, we show that self-reported menstrual tracker data can reveal statistically significant relationships between per-person cycle length variability and self-reported qualitative symptoms. A concern for self-tracked data is that they reflect not only physiological behaviors, but also the engagement dynamics of app users. To mitigate such potential artifacts, we develop a procedure to exclude cycles lacking user engagement, thereby allowing us to better distinguish true menstrual patterns from tracking anomalies. We uncover that women located at different ends of the menstrual variability spectrum, based on the consistency of their cycle length statistics, exhibit statistically significant differences in their cycle characteristics and symptom tracking patterns. We also find that cycle and period length statistics are stationary over the app usage timeline across the variability spectrum. The symptoms that we identify as showing statistically significant association with timing data can be useful to clinicians and users for predicting cycle variability from symptoms, or as potential health indicators for conditions like endometriosis. Our findings showcase the potential of longitudinal, high-resolution self-tracked data to improve understanding of menstruation and women’s health as a whole.
more » « less- NSF-PAR ID:
- 10156220
- Publisher / Repository:
- Nature Publishing Group
- Date Published:
- Journal Name:
- npj Digital Medicine
- Volume:
- 3
- Issue:
- 1
- ISSN:
- 2398-6352
- Format(s):
- Medium: X
- Sponsoring Org:
- National Science Foundation
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Background The physical and emotional well-being of women is critical for healthy pregnancy and birth outcomes. The Two Happy Hearts intervention is a personalized mind-body program coached by community health workers that includes monitoring and reflecting on personal health, as well as practicing stress management strategies such as mindful breathing and movement. Objective The aims of this study are to (1) test the daily use of a wearable device to objectively measure physical and emotional well-being along with subjective assessments during pregnancy, and (2) explore the user’s engagement with the Two Happy Hearts intervention prototype, as well as understand their experiences with various intervention components. Methods A case study with a mixed design was used. We recruited a 29-year-old woman at 33 weeks of gestation with a singleton pregnancy. She had no medical complications or physical restrictions, and she was enrolled in the Medi-Cal public health insurance plan. The participant engaged in the Two Happy Hearts intervention prototype from her third trimester until delivery. The Oura smart ring was used to continuously monitor objective physical and emotional states, such as resting heart rate, resting heart rate variability, sleep, and physical activity. In addition, the participant self-reported her physical and emotional health using the Two Happy Hearts mobile app–based 24-hour recall surveys (sleep quality and level of physical activity) and ecological momentary assessment (positive and negative emotions), as well as the Perceived Stress Scale, Center for Epidemiologic Studies Depression Scale, and State-Trait Anxiety Inventory. Engagement with the Two Happy Hearts intervention was recorded via both the smart ring and phone app, and user experiences were collected via Research Electronic Data Capture satisfaction surveys. Objective data from the Oura ring and subjective data on physical and emotional health were described. Regression plots and Pearson correlations between the objective and subjective data were presented, and content analysis was performed for the qualitative data. Results Decreased resting heart rate was significantly correlated with increased heart rate variability (r=–0.92, P<.001). We found significant associations between self-reported responses and Oura ring measures: (1) positive emotions and heart rate variability (r=0.54, P<.001), (2) sleep quality and sleep score (r=0.52, P<.001), and (3) physical activity and step count (r=0.77, P<.001). In addition, deep sleep appeared to increase as light and rapid eye movement sleep decreased. The psychological measures of stress, depression, and anxiety appeared to decrease from baseline to post intervention. Furthermore, the participant had a high completion rate of the components of the Two Happy Hearts intervention prototype and shared several positive experiences, such as an increased self-efficacy and a normal delivery. Conclusions The Two Happy Hearts intervention prototype shows promise for potential use by underserved pregnant women.more » « less
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Abstract STUDY QUESTION Can we derive adequate models to predict the probability of conception among couples actively trying to conceive?
SUMMARY ANSWER Leveraging data collected from female participants in a North American preconception cohort study, we developed models to predict pregnancy with performance of ∼70% in the area under the receiver operating characteristic curve (AUC).
WHAT IS KNOWN ALREADY Earlier work has focused primarily on identifying individual risk factors for infertility. Several predictive models have been developed in subfertile populations, with relatively low discrimination (AUC: 59–64%).
STUDY DESIGN, SIZE, DURATION Study participants were female, aged 21–45 years, residents of the USA or Canada, not using fertility treatment, and actively trying to conceive at enrollment (2013–2019). Participants completed a baseline questionnaire at enrollment and follow-up questionnaires every 2 months for up to 12 months or until conception. We used data from 4133 participants with no more than one menstrual cycle of pregnancy attempt at study entry.
PARTICIPANTS/MATERIALS, SETTING, METHODS On the baseline questionnaire, participants reported data on sociodemographic factors, lifestyle and behavioral factors, diet quality, medical history and selected male partner characteristics. A total of 163 predictors were considered in this study. We implemented regularized logistic regression, support vector machines, neural networks and gradient boosted decision trees to derive models predicting the probability of pregnancy: (i) within fewer than 12 menstrual cycles of pregnancy attempt time (Model I), and (ii) within 6 menstrual cycles of pregnancy attempt time (Model II). Cox models were used to predict the probability of pregnancy within each menstrual cycle for up to 12 cycles of follow-up (Model III). We assessed model performance using the AUC and the weighted-F1 score for Models I and II, and the concordance index for Model III.
MAIN RESULTS AND THE ROLE OF CHANCE Model I and II AUCs were 70% and 66%, respectively, in parsimonious models, and the concordance index for Model III was 63%. The predictors that were positively associated with pregnancy in all models were: having previously breastfed an infant and using multivitamins or folic acid supplements. The predictors that were inversely associated with pregnancy in all models were: female age, female BMI and history of infertility. Among nulligravid women with no history of infertility, the most important predictors were: female age, female BMI, male BMI, use of a fertility app, attempt time at study entry and perceived stress.
LIMITATIONS, REASONS FOR CAUTION Reliance on self-reported predictor data could have introduced misclassification, which would likely be non-differential with respect to the pregnancy outcome given the prospective design. In addition, we cannot be certain that all relevant predictor variables were considered. Finally, though we validated the models using split-sample replication techniques, we did not conduct an external validation study.
WIDER IMPLICATIONS OF THE FINDINGS Given a wide range of predictor data, machine learning algorithms can be leveraged to analyze epidemiologic data and predict the probability of conception with discrimination that exceeds earlier work.
STUDY FUNDING/COMPETING INTEREST(S) The research was partially supported by the U.S. National Science Foundation (under grants DMS-1664644, CNS-1645681 and IIS-1914792) and the National Institutes for Health (under grants R01 GM135930 and UL54 TR004130). In the last 3 years, L.A.W. has received in-kind donations for primary data collection in PRESTO from FertilityFriend.com, Kindara.com, Sandstone Diagnostics and Swiss Precision Diagnostics. L.A.W. also serves as a fibroid consultant to AbbVie, Inc. The other authors declare no competing interests.
TRIAL REGISTRATION NUMBER N/A.
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null (Ed.)Dimensions of human mood, behaviour and vital signs cycle over multiple timescales. However, it remains unclear which dimensions are most cyclical, and how daily, weekly, seasonal and menstrual cycles compare in magnitude. The menstrual cycle remains particularly understudied because, not being synchronized across the population, it will be averaged out unless menstrual cycles can be aligned before analysis. Here, we analyse 241 million observations from 3.3 million women across 109 countries, tracking 15 dimensions of mood, behaviour and vital signs using a women’s health mobile app. Out of the daily, weekly, seasonal and menstrual cycles, the menstrual cycle had the greatest magnitude for most of the measured dimensions of mood, behaviour and vital signs. Mood, vital signs and sexual behaviour vary most substantially over the course of the menstrual cycle, while sleep and exercise behaviour remain more constant. Menstrual cycle effects are directionally consistent across countries.more » « less
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Abstract Endometriosis is a systemic and chronic condition in women of childbearing age, yet a highly enigmatic disease with unresolved questions: there are no known biomarkers, nor established clinical stages. We here investigate the use of patient-generated health data and data-driven phenotyping to characterize endometriosis patient subtypes, based on their reported signs and symptoms. We aim at unsupervised learning of endometriosis phenotypes using self-tracking data from personal smartphones. We leverage data from an observational research study of over 4000 women with endometriosis that track their condition over more than 2 years. We extend a classical mixed-membership model to accommodate the idiosyncrasies of the data at hand, i.e., the multimodality and uncertainty of the self-tracked variables. The proposed method, by jointly modeling a wide range of observations (i.e., participant symptoms, quality of life, treatments), identifies clinically relevant endometriosis subtypes. Experiments show that our method is robust to different hyperparameter choices and the biases of self-tracking data (e.g., the wide variations in tracking frequency among participants). With this work, we show the promise of unsupervised learning of endometriosis subtypes from self-tracked data, as learned phenotypes align well with what is already known about the disease, but also suggest new clinically actionable findings. More generally, we argue that a continued research effort on unsupervised phenotyping methods with patient-generated health data via new mobile and digital technologies will have significant impact on the study of enigmatic diseases in particular, and health in general.
