NCT03128983

Brief Summary

Research results suggest changes of physiological parameters such as heart rate, respiration, skin conductance response, sleep duration, sleep quality and skin perfusion during the menstrual cycle. Latest fitness trackers allow to conveniently and non-invasively record these parameters. The present study aims to evaluate whether there is a correlation between physiological parameters and the menstrual cycle i.e. ovulation as measured by a urine ovulation test and the onset of menses. To collect data women will wear two smartwatches and a smartshirt at night. All three devices are CE-approved for sports and fitness.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

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

February 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

1.9 years

First QC Date

April 21, 2017

Last Update Submit

November 6, 2018

Conditions

Fertility

Outcome Measures

Primary Outcomes (1)

  • Correlation between menstrual cycle dynamics and physiology

    Correlation between a combination of the physiological parameters heart rate, respiration, skin conductance response, sleep duration, sleep quality and skin perfusion and menstrual cycle dynamics.

    During 1 menstrual cycle between 24 days and 35 days

Interventions

Participants wear a sensor bracelet for collecting physiological data and conducted urine tests to estimate the day of ovulationDEVICE

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe monitoring of menstrual cycles requires female participants.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A maximum of 50 healthy, 20-40 years old, non-pregnant women will be included in the study.

You may qualify if:

  • Healthy, non-pregnant women aged 20-40 years (healthy volunteers)
  • Regular cycling (28 days +/- 2)
  • Non-hormonal contraception methods used
  • German-speaking
  • Written informed consent to participate in the study

You may not qualify if:

  • Any health-related issues that may affect menstrual cycle
  • Any consumption of medication or other substances that may affect the menstrual cycle or any of the physiological parameters investigated
  • Frequent travel between time zones
  • Sleeping disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2017

First Posted

April 25, 2017

Study Start

February 1, 2015

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

November 7, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share