NCT04065464

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

August 5, 2019

Last Update Submit

September 25, 2020

Conditions

Fertility MonitorCycle Tracking

Outcome Measures

Primary Outcomes (1)

  • Fine-tuning Ava algorithm

    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

Interventions

Ava Fertility TrackerDEVICE

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

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All women aged 18 to 40 years matching the eligibility criteria can be enrolled in the pilot study.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZEG Berlin

Mitte, State of Berlin, 10115, Germany

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Project Management, Principal Investigator

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 22, 2019

Study Start

July 3, 2019

Primary Completion

December 20, 2019

Study Completion

January 10, 2020

Last Updated

September 28, 2020

Record last verified: 2020-09

Locations

DE(1)