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| Name | Class |
|---|---|
| Ava AG | INDUSTRY |
| CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| avaOnly | Participants will measure with Ava bracelet and determine ovulation with a home (luteinizing hormone) LH urine test |
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| avaSaliva | 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. |
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| avaSalivaUS | 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. |
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| avaBBT | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ava | Device | Ava is a fertility monitoring bracelet that collects various physiological parameters |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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In this study we want to conduct measurements of physiological data as well as hormonal and ultrasound measurements of growing follicles/ ovulation in a group of endocrinologically healthy women with a regular cycle, who aim for a spontaneous pregnancy. We choose these women 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 the initiation of pregnancy.
We want to continue measurements in all pregnancies beginning during the study period 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 preeclampsia. This will be highly valuable to develop study protocols for the specific evaluation of the screening potential of one of the pregnancy complications.
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| Name | Affiliation | Role |
|---|---|---|
| Brigitte Leeners, Prof | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Reproductive Endocrinology | Zurich | 8091 | Switzerland |
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| Correlation between physiology and pregnancy complications | November 2016 - November 2020 |