TRACY - Track My Cycle
Completed
- Conditions
- Fertility MonitorCycle Tracking
- Registration Number
- NCT04065464
- Lead Sponsor
- Center for Epidemiology and Health Research, Germany
- Brief Summary
The primary aim of the pilot study is to collect data for the fine-tuning and evaluation of the Ava algorithm. Secondary outcomes are the estimation of the accuracy in detecting the fertility status of each cycle day.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 303
Inclusion Criteria
- Aged between 18 and 40 at the time of admission
- Not pregnant and no pregnancy wish during the pilot study period
- Have a regular sleep pattern (sleep at least four hours per night and not working nightshift)
- Have regular menstrual cycles
Exclusion Criteria
- Pregnant at study admission
- Currently breastfeeding or have breastfed in the past 6 months before study admission
- Currently using hormonal contraception or hormonal medication
- Health-related conditions that may affect menstrual cycle length and variability (e.g. PCOS, menopause, thyroid dysfunction)
- Unable to understand study instructions and/or not able to understand English or German
- More than one international overseas travel per month
- Unwilling to sign the ICF.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fine-tuning Ava algorithm 5 months Number of days within a menstrual cycle that are correctly predicted as 'fertile' by the Ava algorithm.
Number of study participants who have their 'fertile window' accurately predicted by the Ava AG app.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ZEG Berlin
🇩🇪Berlin-Mitte, Berlin, Germany