1. What is this study about?
This clinical research study is evaluating a mobile application, called FabVue, which uses a fertility awareness based algorithm to help women understand their daily risk of pregnancy. The study will assess how effective the app is at helping users avoid pregnancy when used as directed over the course of one year.
2. Is this a birth control product that is already approved?
No. FabVue is an investigational digital health tool. It is being tested in this study and is not yet approved for use as a contraceptive product. This clinical trial is designed to collect safety and effectiveness data.
3. What is involved if I participate in the study?
If eligible and enrolled, you will be asked to:
- Wear a ring device (provided by the study)
- Use the FabVue mobile app daily to view your individual pregnancy risk (“low” or “high”)
- Log your menstrual cycle and sexual activity in the app
- Complete periodic surveys over 12 months
- Use the guidance in the app as your primary birth control method
4. What kind of birth control is this?
The FabVue app uses fertility awareness which means it helps you understand when you're more or less likely to get pregnant, based on your personal cycle and data from the smart ring. On “high risk” days, backup contraception will be recommended.
5. Is the ring a form of birth control?
No, the ring (a wearable device) is used to collect biometric data, which helps inform the app’s algorithm. It is not a contraceptive device on its own.
6. What happens if I become pregnant during the study?
If you become pregnant during the study, you will no longer participate in study activities but may be asked to complete an exit survey. Your safety and well-being remain our top priority.
7. Will I be compensated?
Yes. Participants who complete study requirements may receive compensation of up to $405 over the course of the study.
8. Can I still participate if I’ve used hormonal birth control in the past?
You may participate as long as you are not currently using or have not used any hormonal contraception (including pills, implants, patches, IUDs, etc.) within the past 3 months.
9. Is the study entirely virtual?
Yes. This is a decentralized clinical trial, meaning all activities can be completed from home using your smartphone and the study app.
10. Who is eligible to participate?
You may be eligible if you:
- Are assigned female at birth
- Are 18–45 years old
- Are currently sexually active with a male partner
- Have regular menstrual cycles (21–35 days)
- Want to avoid pregnancy for at least one year
- Have not been diagnosed with infertility
- Are not currently pregnant, breastfeeding, or using hormonal contraception or non-hormonal copper IUD.
11. Will my data be kept confidential?
Yes. All personal and health information collected during the study will be stored securely and only used for study purposes. It will not be shared or sold to third parties.
12. How do I get started?
You can begin by completing the online pre-screener to see if you qualify.