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OpenTrials
Completed

NCT Number: NCT04065464

TRACY - Track My Cycle

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.

Completed

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Key information

Conditions

Fertility Monitor Cycle Tracking

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

ZEG Berlin

Mitte, State of Berlin, 10115, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ava Fertility Tracker

Device

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Center for Epidemiology and Health Research, Germany

Other

Collaborators

  • Ava AG

Registry information

Acronym: TRACY

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 22, 2019
Registry last updated
Sep 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.