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This prospective study will evaluate the efficacy of Diafert as an adjunct to morphological assessment in predicting embryos' potential to develop to the blastocyst stage on Day 5.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non treatment group | This is a non-interventional study in which embryo selection is performed according to standard of care. The Diafert output, the granulocyte colony-stimulating factor (G-CSF) concentration in follicular fluid (FF), will be recorded but will not be used in patient management, ie, values will not be used for embryo selection in the assisted reproduction procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diafert | Device | The Diafert output, the G-CSF concentration in FF, will be recorded but will not be used in patient management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Embryos that achieve the blastocyst stage of development at Day 5 as determined by morphological assessment using the SART criteria | The status of each embryo will be assessed by an independent panel of 5 embryologists through visual inspection using the Society for Assisted Reproductive Technology (SART) criteria to determine if each embryo has achieved the blastocyst stage of development or not. | Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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Female outpatients involved in an assisted reproduction procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Fabian Somers, PhD | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntington Reproductive Center | Encino | California | 91436 | United States | ||
| Women's Medical Research Group |
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Human follicular fluid
| Clearwater |
| Florida |
| 33759 |
| United States |
| InVia Fertility Specialists | Hoffman Estates | Illinois | 60169 | United States |
| Institute for Reproductive Health | Cincinnati | Ohio | 45209 | United States |
| Main Line Fertility Center | Bryn Mawr | Pennsylvania | 19010 | United States |
| Dallas - Fort Worth Fertility Associates | Dallas | Texas | 75231 | United States |
| Houston Fertility Institute | Houston | Texas | 77063 | United States |
| Utah Fertiity Center | Pleasant Grove | Utah | 84062 | 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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