Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)

Study Overview
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Brief Summary
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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.

Official Title
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Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)

Conditions
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Fertility Disorders, Early Pregnancy

Intervention / Treatment
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* Device: Ava


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| avaOnly<br>Participants will measure with Ava bracelet and determine ovulation with a home (luteinizing hormone) LH urine test | Device: Ava<br>* Ava is a fertility monitoring bracelet that collects various physiological parameters<br>|
| avaSaliva<br>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<br>* Ava is a fertility monitoring bracelet that collects various physiological parameters<br>|
| avaSalivaUS<br>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<br>* Ava is a fertility monitoring bracelet that collects various physiological parameters<br>|
| avaBBT<br>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. | Device: Ava<br>* Ava is a fertility monitoring bracelet that collects various physiological parameters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Correlation between physiology and pregnancy complications |  | November 2016 - November 2020 |