Physiological Data in the Menstrual Cycle (PDMC)

Variations of Physiological Data Throughout 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.

Study Overview

• Status: Completed
• Conditions: Fertility
• Intervention / Treatment: Device: Participants wear a sensor bracelet for collecting physiological data and conducted urine tests to estimate the day of ovulation

• Study Type: Observational
• Enrollment (Actual): 41

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ava AG
• Collaborators: University Hospital, Zürich; Empa, Swiss Federal Laboratories for Materials Science and Technology; Centre Suisse d'Electronique et de Microtechnique (CSEM), Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: April 21, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Emilia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No