TRACY - Track My Cycle

Center for Epidemiology and Health Research, Germany

Status: Completed

Conditions: Cycle Tracking; Fertility Monitor

Treatments: Device: Ava Fertility Tracker

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04065464

ZEG2019_01

Details and patient eligibility

About

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.

Enrollment: 303 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.