NCT03161873

Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 194 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fertility Disorders
• Early Pregnancy

Interventions

Type	Name	Description
DEVICE	Ava	Ava is a fertility monitoring bracelet that collects various physiological parameters

Timeline

• Start date: 2016-11-01
• Primary completion: 2020-11-01
• Completion: 2020-11-01
• First posted: 2017-05-22
• Last updated: 2022-09-28

Locations

1 site across 1 country: Switzerland

Regulatory

• FDA-regulated device study