Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)

NCT03161873 | Completed FDA Device

• 1 other identifier: S_US_Ava
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility Disorders; Early Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Correlation between the physiology measured using a wearable device and the occurrence of pregnancy

  November 2016 - November 2020

• Correlation between physiology and pregnancy complications

  November 2016 - November 2020

Study Arms (4)

avaOnly

Participants will measure with Ava bracelet and determine ovulation with a home (luteinizing hormone) LH urine test

Device: Ava

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

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

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

Interventions

Ava DEVICE

Ava is a fertility monitoring bracelet that collects various physiological parameters

avaBBT; avaOnly; avaSaliva; avaSalivaUS

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• women aged 20-40 years
• regular menstrual cycle (28 days+/-)
• no hormonal therapy
• German-speaking
• written informed consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Ava AG: collaborator
• CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement: collaborator

Study Sites (1)

Clinic for Reproductive Endocrinology

Zurich, 8091, Switzerland

Location

Study Officials

• Brigitte Leeners, Prof

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 22, 2017
• Study Start: November 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)