Fertility Clinical Trial
— PDMCOfficial title:
Variations of Physiological Data Throughout the Menstrual Cycle
NCT number | NCT03128983 |
Other study ID # | Emilia |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2015 |
Est. completion date | December 31, 2016 |
Verified date | November 2018 |
Source | Ava AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ava AG | Centre Suisse d’Electronique et de Microtechnique (CSEM), Switzerland, Eidgenössische Materialprüfungs- und Forschungsanstalt (EMPA), Switzerland, University Hospital, Zürich |
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 |
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