Cycle Tracking, Fertility Monitor
Conditions
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.
Interventions
DEVICEAva Fertility Tracker
All women aged 18 to 40 years using Ava Fertility Tracker to track their cycles.
Sponsors
Ava AG
Center for Epidemiology and Health Research, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fine-tuning Ava algorithm | 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. |
Countries
Germany
Outcome results
None listed