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

University of Zurich (UZH)

Status: Completed

Conditions: Fertility Disorders; Early Pregnancy

Treatments: Device: Ava

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03161873

S_US_Ava

Details and patient eligibility

About

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.

Enrollment: 194 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

194 participants in 4 patient groups

avaOnly

Description:

Participants will measure with Ava bracelet and determine ovulation with a home (luteinizing hormone) LH urine test

Treatment:

Device: Ava

avaSaliva

Description:

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.

Treatment:

Device: Ava

avaSalivaUS

Description:

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.

Treatment:

Device: Ava

avaBBT

Description:

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.

Treatment:

Device: Ava