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Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)

NCT03161873 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 194

Last updated 2022-09-28

No results posted yet for this study

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

Interventions

DEVICE

Ava

Ava is a fertility monitoring bracelet that collects various physiological parameters

Sponsors & Collaborators

  • Ava AG

    collaborator INDUSTRY

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

    collaborator INDUSTRY

  • University of Zurich

    lead OTHER

Principal Investigators

  • Brigitte Leeners, Prof · University of Zurich

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2020-11-30
Completion
2020-11-30
FDA Device
Yes

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03161873 on ClinicalTrials.gov