Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA) (SUSAVA)

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.

Study Overview

• Status: Completed
• Conditions: Fertility Disorders; Early Pregnancy
• Intervention / Treatment: Device: Ava

• Study Type: Observational
• Enrollment (Actual): 194

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8091
    • Clinic for Reproductive Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
avaOnly; Participants will measure with Ava bracelet and determine ovulation with a home (luteinizing hormone) LH urine test	Device: Ava; Ava is a fertility monitoring bracelet that collects various physiological parameters
avaSaliva; 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.	Device: Ava; Ava is a fertility monitoring bracelet that collects various physiological parameters
avaSalivaUS; 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.	Device: Ava; Ava is a fertility monitoring bracelet that collects various physiological parameters
avaBBT; 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.	Device: Ava; Ava is a fertility monitoring bracelet that collects various physiological parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the physiology and the menstrual cycle dynamics	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	November 2016 - November 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the physiology measured using a wearable device and the occurrence of pregnancy	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.	November 2016 - November 2020
Correlation between physiology and pregnancy complications		November 2016 - November 2020

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement; Ava AG
• Investigators: Principal Investigator: Brigitte Leeners, Prof, University of Zurich

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ACTUAL): November 1, 2020
• Study Completion (ACTUAL): November 1, 2020

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (ACTUAL): May 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: S_US_Ava

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No