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| Name | Class |
|---|---|
| OTO US Fertility LP | UNKNOWN |
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The purpose of this study is to determine if physiological measures of stress, measured by the non-invasive OTO device, are significantly correlated with IVF outcome.
The OTO device is a wearable device that utilizes multiple methods of electrophysiology to identify the impact of stress on humans. The device consists of the OTO sensor, a belt with two electrode pads worn around the chest, one electrode placed on the thenar of the dominant hand and one electrode placed on the forehead; the sensor pairs with the OTO App via Bluetooth. It tracks 54 physiological properties including temperature, HRV, amplitude frequency analysis (AFA) of ECG and DC potential. This data is analyzed by the proprietary OTO Expert System which creates the overall conclusions on levels of stress, functional reserves, adaptive capacity and level of readiness to additional stressors.
Physiological data will be collected from the study participant using the OTO device for the duration of one IVF and frozen embryo transfer (FET) cycle. Study participants will complete questionnaires online related to perceived stress at the beginning and the end of study participation. Study participant's IVF cycle treatment and outcome data will be collected and analyzed in conjunction with the physiological data collected with the OTO device.
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| Measure | Description | Time Frame |
|---|---|---|
| Physiological Stress | Physiological stress will be measured using the non-invasive OTO device, which tracks 54 physiological properties including temperature, hear rate variability (HRV), amplitude frequency analysis (AFA) of electrocardiogram (ECG) and direct current (DC) potential. | 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Women between age 25-40 years old who are scheduled to undergo their first IVF and frozen embryo transfer cycle at one of the participating fertility clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Alice Domar, PhD | Inception Fertility Research Institute, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVFMD | Boca Raton | Florida | 33428 | United States | ||
| Center for Reproductive Medicine |
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| Label | URL |
|---|---|
| Inception Network Fertility Studies - OTO | View source |
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| Celebration |
| Florida |
| 34747 |
| United States |
| IVFMD | Cooper City | Florida | 33024 | United States |
| IVFMD | Jupiter | Florida | 33458 | United States |
| IVFMD | Miami | Florida | 33143 | United States |
| IVFMD | Naples | Florida | 34108 | United States |
| IVFMD | Viera | Florida | 32940 | United States |
| Center for Reproductive Medicine | Winter Park | Florida | 32789 | United States |
| Reproductive Biology Associates | Atlanta | Georgia | 30309 | United States |
| Reproductive Biology Associates | Atlanta | Georgia | 30342 | United States |
| Reproductive Biology Associates | Cumming | Georgia | 30041 | United States |
| Reproductive Biology Associates | Lawrenceville | Georgia | 30046 | United States |
| Reproductive Biology Associates | Marietta | Georgia | 30060 | United States |
| Advanced Fertility Center of Chicago | Chicago | Illinois | 60630 | United States |
| Advanced Fertility Center of Chicago | Crystal Lake | Illinois | 60014 | United States |
| Advanced Fertility Center of Chicago | Downers Grove | Illinois | 60515 | United States |
| Advanced Fertility Center of Chicago | Gurnee | Illinois | 60031 | United States |
| Indiana Fertility Institute | Indianapolis | Indiana | 46280 | United States |
| Main Line Fertility | Bryn Mawr | Pennsylvania | 19010 | United States |
| Main Line Fertility | Havertown | Pennsylvania | 19083 | United States |
| Main Line Fertility | Paoli | Pennsylvania | 19301 | United States |
| Main Line Fertility | Philadelphia | Pennsylvania | 19107 | United States |
| Main Line Fertility | West Chester | Pennsylvania | 19380 | United States |
| Tennessee Fertility Institute | Franklin | Tennessee | 37067 | United States |
| Tennessee Fertility Institute | Nashville | Tennessee | 37203 | United States |
| Aspire Fertility Austin | Austin | Texas | 78705 | United States |
| Aspire Houston Fertility Institute | Beaumont | Texas | 77706 | United States |
| Aspire Houston Fertility Institute | Cypress | Texas | 77433 | United States |
| Aspire Fertility Dallas | Dallas | Texas | 75001 | United States |
| Aspire Houston Fertility Institute - Memorial City | Houston | Texas | 77024 | United States |
| Aspire Houston Fertility Institute - Main Street | Houston | Texas | 77030 | United States |
| Aspire Houston Fertility Institute - Medical Center | Houston | Texas | 77054 | United States |
| Aspire Houston Fertility Institute - Piney Point | Houston | Texas | 77063 | United States |
| Aspire Houston Fertility Institute - Willowbrook | Houston | Texas | 77070 | United States |
| Aspire Houston Fertility Institute | Katy | Texas | 77494 | United States |
| Aspire Houston Fertility Institute | Kingwood | Texas | 77339 | United States |
| Aspire Fertility McAllen | McAllen | Texas | 78504 | United States |
| Aspire Houston Fertility Institute | Pearland | Texas | 77584 | United States |
| Aspire Fertility San Antonio - Medical Center | San Antonio | Texas | 78229 | United States |
| Aspire Fertility San Antonio - Sonterra | San Antonio | Texas | 78258 | United States |
| Aspire Houston Fertility Institute | Sugar Land | Texas | 77479 | United States |
| Aspire Houston Fertility Institute | The Woodlands | Texas | 77385 | United States |
| Aspire Houston Fertility Institute | Webster | Texas | 77598 | United States |
| ID | Term |
|---|---|
| D007246 | Infertility |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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