Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)

Fertility Disorders Clinical Trial

— SUSAVA  

Official title:

Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03161873
• Other study ID #: S_US_Ava
• Status: Completed
• Start date: November 2016
• Est. completion date: November 2020

Study information

• Verified date: September 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Pregnancy
• Fertility Disorders

Intervention

Device:
• Ava
Ava is a fertility monitoring bracelet that collects various physiological parameters

Locations

Country	Name	City	State
Switzerland	Clinic for Reproductive Endocrinology	Zürich

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	Ava AG, CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation between the physiology measured using a wearable device and the occurrence of pregnancy	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.	November 2016 - November 2020
Secondary	Correlation between physiology and pregnancy complications		November 2016 - November 2020