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

Sponsor
University of Zurich (Other)
Overall Status
Unknown status
CT.gov ID
NCT03161873
Collaborator
Ava AG (Industry), CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement (Industry)
430
Enrollment
1
Location
48
Anticipated Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ava

Study Design

Study Type:
Observational
Anticipated Enrollment :
430 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)
Actual Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Nov 1, 2020
Anticipated Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. Correlation between physiology and pregnancy complications [November 2016 - November 2020]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinic for Reproductive Endocrinology Zürich Switzerland 8091

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Brigitte Leeners, Prof, University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Zurich
ClinicalTrials.gov Identifier:
NCT03161873
Other Study ID Numbers:
  • S_US_Ava
First Posted:
May 22, 2017
Last Update Posted:
Jan 27, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of Jan 27, 2020