Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)

Completed

• Conditions: Early Pregnancy; Fertility Disorders
• Interventions: Device: Ava

• 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

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-22
• Primary Completion: 2020-11
• Study Completion: 2020-11
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 194

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
avaSalivaUS	Ava	Participants will measure with Ava bracelet and determine ovulation with a home LH urine test. In addition participants will collect saliva for the measurements of estrogen and progesterone. Moreover ultrasound will be used to observe the day at which the ovum is released.
avaSaliva	Ava	Participants will measure with Ava bracelet and determine ovulation with a home LH urine test. In addition participants will collect saliva for the measurements of estrogen and progesterone.
avaOnly	Ava	Participants will measure with Ava bracelet and determine ovulation with a home (luteinizing hormone) LH urine test
avaBBT	Ava	Participants will measure with Ava bracelet and determine ovulation with a home LH urine test. In addition, participants will measure their basal body temperature (BBT) daily.

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

Trial Locations

Locations (1)

Clinic for Reproductive Endocrinology; 🇨🇭 Zürich, Switzerland