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TRACY - Track My Cycle (TRACY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065464
Recruitment Status : Active, not recruiting
First Posted : August 22, 2019
Last Update Posted : September 2, 2019
Sponsor:
Collaborator:
Ava AG
Information provided by (Responsible Party):
Clare Barnett, MBBS (Hons) MPH, Center for Epidemiology and Health Research, Germany

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 of each cycle day.

Condition or disease Intervention/treatment
Fertility Monitor Cycle Tracking Device: Ava Fertility Tracker

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TRACY - Track My Cycle
Actual Study Start Date : July 3, 2019
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : November 30, 2019

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


Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065464


Locations
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Germany
ZEG Berlin
Berlin-Mitte, Berlin, Germany, 10115
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Ava AG

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Responsible Party: Clare Barnett, MBBS (Hons) MPH, Director of Project Management, Principal Investigator, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT04065464     History of Changes
Other Study ID Numbers: ZEG2019_01
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No