Clinical trial NCT03161873: Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)
Official title: Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertility Disorders
Early Pregnancy
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Ava AG
name: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
First posted: 2017-05-22
Enrollment: 194
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study we want to conduct measurements of physiological data as well as hormonal and ultrasound measurements of growing follicles/ ovulation in a group of endocrinologically healthy women with a regular cycle, who aim for a spontaneous pregnancy. We choose these women 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 the initiation of pregnancy.

We want to continue measurements in all pregnancies beginning during the study period 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 preeclampsia. This will be highly valuable to develop study protocols for the specific evaluation of the screening potential of one of the pregnancy complications.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Correlation between the physiology and the menstrual cycle dynamics
timeFrame: November 2016 - November 2020
Secondary outcomes:
measure: Correlation between the physiology measured using a wearable device and the occurrence of pregnancy
timeFrame: November 2016 - November 2020
measure: Correlation between physiology and pregnancy complications
timeFrame: November 2016 - November 2020
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Clinic for Reproductive Endocrinology
Study officials:
affiliation: University of Zurich
name: Brigitte Leeners, Prof
role: PRINCIPAL_INVESTIGATOR
References: