NCT04065464CompletedNot Applicable
TRACY - Track My Cycle
Center for Epidemiology and Health Research, Germany1 site in 1 country303 target enrollmentStarted: July 3, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 303
- Locations
- 1
- Primary Endpoint
- Fine-tuning Ava algorithm
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Clare Barnett, MBBS (Hons) MPH
Director of Project Management, Principal Investigator
Center for Epidemiology and Health Research, Germany
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Evaluation of the Eversense Continuous Glucose Monitoring System in Type I Diabetic YouthSelf CareNCT03815552Kinderkrankenhaus auf der Bult15
Completed
Not Applicable
Pilot Study: AI Algorithm for Dermatology Referral OptimizationSkin DiseasesSkin ConditionNCT06228014AI Labs Group S.L200
Recruiting
Not Applicable
Telematics Device for Daily Monitoring of Vital Signs in CancerCardiovascular DiseasesRespiratory DiseaseCancerNCT05650814Fondazione ANT Italia ONLUS50
Completed
Not Applicable
The Development of a System for Measurement of TremorEssential TremorDystoniaNCT05956223The Bionics Institute of Australia43
Completed
Not Applicable
Collection of Information by Tocography ExternalPregnancy RelatedNCT03444909BioSerenity35