A Prospective Observational Study on the Contraceptive Effectiveness of the Natural Cycles Application (The VENUS Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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. Days not estimated to be fertile are shown as "green" and labeled "Not fertile".
Rationale:
This is a prospective, observational study designed to evaluate the contraceptive effectiveness of the Natural Cycles application under real-world conditions. While previous large-scale studies have established the effectiveness of NC°, they were largely observational analyses of passively logged user data. To meet evolving regulatory standards for contraceptive trials, particularly those mandated by the U.S. Food and Drug Administration (FDA), this prospective study has been designed to systematically capture intercourse and pregnancy outcomes on a cycle-by-cycle basis. This methodology overcomes the limitations of purely passive data collection and will yield a more complete and robust dataset for effectiveness calculations.
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 enter data on a daily basis and perform pregnancy tests as requested by protocol.
- •Is willing to complete a satisfaction survey at the end of her study participation.
排除标准
- •Has EU-citizenship
- •Has had a Depo-Provera injection in the last 10 months or has had less than three consecutive, spontaneous menstrual cycles since their last injection.
- •Has had less than three consecutive, spontaneous menstrual cycles after removing a hormonal implant.
- •Has had less than three consecutive, spontaneous menstrual cycles after the end of a pregnancy.
- •Has had less than three consecutive, spontaneous menstrual cycles since she last breastfed.
- •Has (or partner has) known fertility issues, such as infertility and sterilization, or have been advised by a healthcare professional that they may have difficulty conceiving for any reason.
- •Has a medical condition possibly impacting fertility, i.e. endometriosis, a history of Pelvic Inflammatory Disease (PID), significant uterine fibroids or adenomyosis, or another diagnosed medical condition that they have been told affects fertility.
- •Is regularly taking one of the following prescribed pharmaceutical medications known to be teratogenic (i.e., a medication that can cause birth defects):
- •Isotretinoin (like Accutane, Absorica, Claravis, or Myorisan) for severe acne Valproic acid or divalproex sodium (like Depakote, Depakene, or Topamax) for seizures (epilepsy), migraines, or bipolar disorder Methotrexate (Trexall, Rheumatrex) or leflunomide (Arava) for autoimmune conditions ACE Inhibitors (like Lisinopril, Enalapril) or Angiotensin II Receptor Blockers (ARBs) (like Losartan, Valsartan) for high blood pressure or heart conditions Warfarin (Coumadin, Jantoven) for blood clot prevention
研究组 & 干预措施
NC° Users Participating in Study
An individual who has recently registered to the Natural Cycles app will be screened based on the information routinely collected at registration and invited to the study if they meet specific screening criteria. After informed consent, the onboarding survey will explicitly verify further inclusion and exclusion criteria with participants.
干预措施: Natural Cycles application (Device)
NC° Users Participating in Study
An individual who has recently registered to the Natural Cycles app will be screened based on the information routinely collected at registration and invited to the study if they meet specific screening criteria. After informed consent, the onboarding survey will explicitly verify further inclusion and exclusion criteria with participants.
干预措施: Log daily intercourse information (Behavioral)