Status:
COMPLETED
TRACY - Track My Cycle
Lead Sponsor:
Center for Epidemiology and Health Research, Germany
Collaborating Sponsors:
Ava AG
Conditions:
Fertility Monitor
Cycle Tracking
Eligibility:
FEMALE
18-40 years
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 3 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 10 2020
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT04065464
Start Date
July 3 2019
End Date
January 10 2020
Last Update
September 28 2020
Active Locations (1)
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1
ZEG Berlin
Mitte, State of Berlin, Germany, 10115