TRACY - Track My Cycle

Cycle Tracking Clinical Trial

— TRACY  

Official title:

TRACY - Track My Cycle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065464
• Other study ID #: ZEG2019_01
• Status: Completed
• Start date: July 3, 2019
• Est. completion date: January 10, 2020

Study information

• Verified date: September 2020
• Source: Center for Epidemiology and Health Research, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: January 10, 2020
• Est. primary completion date: December 20, 2019
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cycle Tracking
• Fertility Monitor

Intervention

Device:
• Ava Fertility Tracker
All women aged 18 to 40 years using Ava Fertility Tracker to track their cycles.

Locations

Country	Name	City	State
Germany	ZEG Berlin	Berlin-Mitte	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Center for Epidemiology and Health Research, Germany	Ava AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fine-tuning Ava algorithm	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.	5 months