Physiological Data in the Menstrual Cycle

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.

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Key information

Conditions

Fertility

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Device

Primary outcomes

Correlation between menstrual cycle dynamics and physiology

Time frame: During 1 menstrual cycle between 24 days and 35 days

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.

Sponsors and collaborators

Lead sponsor

Ava AG

Industry

Collaborators

Centre Suisse d'Electronique et de Microtechnique (CSEM), Switzerland
Empa, Swiss Federal Laboratories for Materials Science and Technology
University Hospital, Zürich

Registry information

Official study title

Variations of Physiological Data Throughout the Menstrual Cycle

Acronym: PDMC

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Apr 25, 2017
Registry last updated: Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed