Physiological Data in the Menstrual Cycle

Fertility Clinical Trial

— PDMC  

Official title:

Variations of Physiological Data Throughout the Menstrual Cycle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03128983
• Other study ID #: Emilia
• Status: Completed
• Start date: February 1, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: November 2018
• Source: Ava AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Ava AG	Centre Suisse d’Electronique et de Microtechnique (CSEM), Switzerland, Eidgenössische Materialprüfungs- und Forschungsanstalt (EMPA), Switzerland, University Hospital, Zürich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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