Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)
- Conditions
- Early PregnancyFertility Disorders
- Registration Number
- NCT03161873
- Lead Sponsor
- University of Zurich
- Brief Summary
In this study physiological data is measured using wearable sensors as well as hormonal and ultrasound measurements of growing follicles/ ovulation in a group of endocrinologically healthy women with regular cycles, who aim for a spontaneous pregnancy. These women were recruited to generate reliable data on changes of the measured physiological parameters in a healthy menstrual cycle, as well as to evaluate physiological changes associated with early pregnancy.
All pregnancies beginning during the study period are to be monitored to their natural end, in order to evaluate how the same nine physiological parameters are changing during pregnancy, how strong the variations of the parameters during pregnancy are, and whether they could be associated with early onsets of pregnancy complications such as premature birth or pre-eclampsia. This will be highly valuable to develop study protocols for the specific evaluation of the screening potential of pregnancy complications.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 194
- women aged 20-40 years
- regular menstrual cycle (28 days+/-)
- no hormonal therapy
- German-speaking
- written informed consent to participate in the study
- 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
- unsuccessfully trying to conceive for > 12 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation between the physiology and the menstrual cycle dynamics November 2016 - November 2020 Correlation between a the following physiological parameters (individually or in combination), pulse rate, respiration, skin conductance response, sleep duration and quality, and skin perfusion with the menstrual cycle dynamics
- Secondary Outcome Measures
Name Time Method Correlation between the physiology measured using a wearable device and the occurrence of pregnancy November 2016 - November 2020 Correlation between the following physiological parameters (individually or in combination), pulse rate, respiration, skin conductance response, sleep duration and quality, and skin perfusion with the occurrence of pregnancy.
Correlation between physiology and pregnancy complications November 2016 - November 2020
Related Research Topics
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Trial Locations
- Locations (1)
Clinic for Reproductive Endocrinology
🇨🇭Zürich, Switzerland
Clinic for Reproductive Endocrinology🇨🇭Zürich, Switzerland