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The purpose of this study is to compare the development of human embryos grown in a conventional culture dish to those grown in a new embryo culture device known as the SMART System.
This study is a multi-center, randomized, performance study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental arm | Experimental | Embryos cultured in SMART System |
|
| Control | Active Comparator | Embryos cultured in microdrops in dishes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMART System | Device | microfluidic embryo culture system |
|
| Measure | Description | Time Frame |
|---|---|---|
| rate of development of human embryos | Day 3 (t=72 hrs) |
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Inclusion Criteria - All recruited subjects must meet all of the following inclusion criteria to be enrolled in the study:
Exclusion Criteria- Potential subjects are excluded from the study if any of the following conditions exist:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas B Pool, Ph.D., HCLD | Fertility Center of San Antonio | Principal Investigator |
| Joseph Conaghan, Ph.D., HCLD | Pacific Fertility Center | Principal Investigator |
| Rodney Wade, BSA, MS, ELD | Southeastern Fertility Center | Principal Investigator |
| Kelvin L Fry, B. SC. | Florida Fertility Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Fertility Center | San Francisco | California | 94133 | United States | ||
| Florida Fertility Institute |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Culture dish | Device | Standard IVF culture dish |
|
|
| Clearwater |
| Florida |
| 33759 |
| United States |
| Southeastern Fertility Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Fertility Center of San Antonio | San Antonio | Texas | 78229 | United States |