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OpenTrials
Completed

NCT Number: NCT03161873

Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Clinic for Reproductive Endocrinology

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ava

Device

Ava is a fertility monitoring bracelet that collects various physiological parameters

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

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

Registry information

Acronym: SUSAVA

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 22, 2017
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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