TRACY - Track My Cycle | NCT04065464

Studies
TRACY - Track My Cycle

NCT04065464

Sponsor

Center for Epidemiology and Health Research, Germany

Status

Completed

Last Update Posted

Sep 28, 2020Actual

Enrollment

303Actual

Phase

Not provided

Conditions

Fertility Monitor
Cycle Tracking

Interventions

Ava Fertility Tracker

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 3, 2019Actual

Primary Completion Date

Dec 20, 2019Actual

Completion Date

Jan 10, 2020Actual

First Submitted Date

Aug 5, 2019

First Submission Date that Met QC Criteria

Aug 20, 2019

First Posted Date

Aug 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2020

Last Update Posted Date

Sep 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Clare Barnett, MBBS (Hons) MPH, Director of Project Management, Principal Investigator, Center for Epidemiology and Health Research, GermanyPrincipal Investigator

Lead Sponsor

Center for Epidemiology and Health Research, GermanyOTHER

Collaborators

Name	Class
Ava AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

303Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ava Fertility Tracker	Device	All women aged 18 to 40 years using Ava Fertility Tracker to track their cycles.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ZEG Berlin		Mitte	State of Berlin	10115	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided