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To evaluate the clinical pregnancy rate (pregnancy defined as fetal heartbeat at 6-8 weeks) with the adjunctive use of the Hera System (Hera System used with traditional morphological grading) with embryos already deemed suitable for transfer compared to trained embryologists using standard morphology criteria alone.
To evaluate the clinical pregnancy rate (pregnancy defined as fetal heartbeat at 6-8 weeks) with the adjunctive use of the Hera System (Hera System used with traditional morphological grading) with embryos already deemed suitable for transfer compared to trained embryologists using standard morphology criteria alone.
To evaluate the performance and utilization of the Hera System as an adjunctive embryo grading and prioritization tool in an embryology lab setting with trained embryologists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Morphology | No Intervention | The embryo selection will be based on standard of care traditional morphology only. | |
| Device: Hera System | Experimental | For the Hera, the embryologist will use the consider both the standard morphology grade and the Hera System score on embryos that were already deemed suitable for transfer or freeze based on the standard morphology assessment to determine the most suitable embryo for transfer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hera Score | Device | The device uses patient metadata (patient age, day of image capture) and a software algorithm to analyze features of the blastocyst morphology to provide adjunctive information that may predict further development of the embryo to clinical pregnancy after embryo transfer. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | The primary study endpoint is clinical pregnancy - defined as a fetal heartbeat at 6-8 weeks. | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of disagreement | Incidence of disagreement for the top-ranked embryo between the Hera System and the embryologist. | week 1 |
| User Experience | Assessment of Hera System usability as reported by the embryologist using a user questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
All women undergoing IVF
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCRM | Menlo Park | California | 94025 | United States | ||
| Reproductive Science Center |
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Randomized Control Trial, 1:1 allocation in treatment and control group.
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|
| through study completion at 8 weeks |
| San Ramon |
| California |
| 94583 |
| United States |
| IVF Florida Reproductive Associates | Margate | Florida | 33063 | United States |
| Center for Reproductive Medicine | Winter Park | Florida | 32789 | United States |
| Ovation Fertility | Austin | Texas | 78731 | United States |
| Aspire Fertility | San Antonio | Texas | 78258 | United States |
| Reproductive Care Center | Sandy City | Utah | 84092 | United States |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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