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

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ClinicalTrials.gov Identifier: NCT03161873
Recruitment Status : Recruiting
First Posted : May 22, 2017
Last Update Posted : January 30, 2019
Sponsor:
Collaborators:
Ava AG
Centre Suisse d'Electronique et Microtechnique SA
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Fertility Disorders Early Pregnancy Device: Ava

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

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




Primary Outcome Measures :
  1. Correlation between the physiology and the menstrual cycle dynamics [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: November 2016 - November 2020 ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161873


Contacts
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Contact: Brigitte Leeners, Prof +41-44 255 5001 Brigitte.Leeners@usz.ch

Locations
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Switzerland
Clinic for Reproductive Endocrinology Recruiting
Zürich, Switzerland, 8091
Contact: Brigitte Leeners, Prof    +41-44 255 5001    Brigitte.Leeners@usz.ch   
Sponsors and Collaborators
University of Zurich
Ava AG
Centre Suisse d'Electronique et Microtechnique SA
Investigators
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Principal Investigator: Brigitte Leeners, Prof University of Zurich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03161873     History of Changes
Other Study ID Numbers: S_US_Ava
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No