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The purpose of this study is to demonstrate that the Eeva System may be used to identify embryos on Day 2 that are most likely to form blastocysts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women undergoing IVF treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eeva System Study | Device | The Eeva System will image embryos through cleavage and/or blastocyst stage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eeva System correctly predicts on day 2 those embryos that will reach blastocyst stage at day 5. | Imaging data will be manually analyzed to validate parameters previously determined to be predictive of blastocyst formation. | Embryos cultured through blastocyst stage (Day 5). |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Outcome | Chemical pregnancy outcome will be assessed using a serum pregnancy test at post transfer day 12-14. Clinical pregnancy outcome will be assessed using vaginal ultrasound at post transfer week 5-8 and week 9-12. Results will be recorded as positive or negative. | Assessed at post embryo transfer day 12-14, post transfer week 5-8, and post transfer week 9-12. |
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Inclusion Criteria:
Exclusion Criteria:
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Women in the United States who undergo IVF treatment and imaging of their embryos with the Eeva System.
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| Name | Affiliation | Role |
|---|---|---|
| Sheua Shen, MD, ELD | Progyny, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HRC Fertility | Encino | California | 91436 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20890283 | Background | Wong CC, Loewke KE, Bossert NL, Behr B, De Jonge CJ, Baer TM, Reijo Pera RA. Non-invasive imaging of human embryos before embryonic genome activation predicts development to the blastocyst stage. Nat Biotechnol. 2010 Oct;28(10):1115-21. doi: 10.1038/nbt.1686. Epub 2010 Oct 3. | |
| 24726214 | Derived | Athayde Wirka K, Chen AA, Conaghan J, Ivani K, Gvakharia M, Behr B, Suraj V, Tan L, Shen S. Atypical embryo phenotypes identified by time-lapse microscopy: high prevalence and association with embryo development. Fertil Steril. 2014 Jun;101(6):1637-48.e1-5. doi: 10.1016/j.fertnstert.2014.02.050. Epub 2014 Apr 14. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Palo Alto |
| California |
| 94304 |
| United States |
| Pacific Fertility Center | San Francisco | California | 94133 | United States |
| Fertility Physicians of Northern California | San Jose | California | 95124 | United States |
| Reproductive Science Center | San Ramon | California | 94583 | United States |