TRACY - Track My Cycle (TRACY)

September 25, 2020 updated by: Clare Barnett, MBBS (Hons) MPH, Center for Epidemiology and Health Research, Germany
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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

303

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: 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.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Epidemiology and Health Research, Germany

Collaborators

Ava AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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