Early Pregnancy, Fertility Disorders
Conditions
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.
Interventions
DEVICEAva
Ava is a fertility monitoring bracelet that collects various physiological parameters
Sponsors
Ava AG
CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
University of Zurich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* women aged 20-40 years * regular menstrual cycle (28 days+/-) * no hormonal therapy * 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 * unsuccessfully trying to conceive for \> 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Switzerland
Outcome results
None listed