A Prospective Observational Study on the Contraceptive Effectiveness of the Natural Cycles Application (The VENUS Study)
Natural Cycles
Summary
The goal of this observational study is to measure the effectiveness of the Natural Cycles digital birth control application at preventing pregnancy in sexually active women aged 18 to 35 with no known history of infertility. The main questions it aims to answer are: * What is the pregnancy rate of the application over one year, for all users? * What is the pregnancy rate of the application over one year, for users who follow the application's instructions perfectly? Participants will: * Use the Natural Cycles application for birth control for up to one year. * Log information about daily sexual activity in the app. * Complete a questionnaire at the beginning and end of their participation. * Perform urine pregnancy tests (provided by mail) upon entry to the study, at the start of every cycle during the study, and upon exit from the study.
Description
Background: Natural Cycles (NC°) is a mobile-based application for contraception and fertility monitoring, cleared by the FDA and certified for contraceptive use in Europe, Brazil, Canada, Australia, Singapore, and South Korea. Based on user input of body temperature, menstruation dates, and optional urine luteinizing hormone tests, the application's algorithm estimates likely ovulation dates, fertile windows, and upcoming menstruation. In NC° Birth Control mode, potentially fertile days are flagged as "red" and labeled "Use protection", informing users to abstain or use barrier protection. D…
Eligibility
- Age range
- 18–35 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Wants to avoid pregnancy for 13 cycles. * Is willing to rely solely on Natural Cycles as their sole contraception method for 13 cycles. * Is not currently using permanent contraceptive methods, such as sterilization (of either the user or their partner), or hormonal methods, such as the hormonal contraceptive implant or IUD. * Has an intact uterus, both ovaries and both fallopian tubes to the best of their knowledge. * Has an average cycle length between 21 and 35 days. The user anticipates heterosexual intercourse at least once a month in the next year. * Is willing to…
Interventions
- BehavioralLog daily intercourse information
For the duration of their participation in the study, participants will use the contraceptive app as usual but will be prompted to diligently log daily intercourse information and to regularly test for pregnancy. Upon exiting the study for any reason, all participants will complete a urine pregnancy test and an online Exit Questionnaire.
- DeviceNatural Cycles application
Users will receive daily fertility status from Natural Cycles application
Location
- Natural Cycles USA CorpNew York, New York