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The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.
The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.
Primary Objectives Include:
To collect imaging data on embryos followed to blastocyst stage (Day 5-6)
Secondary Objectives Include:
To collect enrollment data: demographics, IVF and pregnancy history To collect Day 3, Day 5 and Day 6 embryo morphology data To collect pregnancy test and outcome data To collect pre-implantation genetic screening (PGS) data (if applicable) To collect Frozen Embryo Transfer (FET) data (if applicable)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eevaâ„¢ Test | Device | The Eeva System is indicated to provide adjunctive information on events occurring during the first two days of development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3 when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit. | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing in vitro fertilization treatment who fulfill all eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Sheua Shen, MD | Vice President, Scientific and Medical Affairs | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FCI (River North) | Chicago | Illinois | 60610 | United States | ||
| Midwest Fertility Specialists |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Carmel |
| Indiana |
| 46032 |
| United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Texas Fertility Center | Austin | Texas | 78731 | United States |
| Houston Fertility Institute | Houston | Texas | 77063 | United States |
| Seattle Reproductive Medicine | Seatlle | Washington | 98109 | United States |
| Fertility Associates | Wellington | 6011 | New Zealand |