TRACY - Track My Cycle (TRACY)

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.

Study Overview

• Status: Completed
• Conditions: Fertility Monitor; Cycle Tracking
• Intervention / Treatment: Device: Ava Fertility Tracker

• Study Type: Observational
• Enrollment (Actual): 303

Contacts and Locations

Study Locations

• Germany
  • Berlin
    • Berlin-Mitte, Berlin, Germany, 10115
      • ZEG Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All women aged 18 to 40 years matching the eligibility criteria can be enrolled in the pilot study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Center for Epidemiology and Health Research, Germany
• Collaborators: Ava AG

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): January 10, 2020

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 22, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2020
• Last Update Submitted That Met QC Criteria: September 25, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ZEG2019_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No