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Retrospective chart review of data on the use of traditional IVF and INVOcell IVC collected from clinics using both technologies. The retrospective data will be utilized for a comparison of the two methods.
The following aspects of data will be collected to support the analysis of the two methods
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INVOcell IVC | IVF using intravaginal incubation with INVOcell device for embryo development. |
| |
| Traditional IVF (tIVF) | Traditional IVF using laboratory equipment and incubators for embryo development |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVOcell IVC | Device | Embryo development in intravaginal incubation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Embryo development | Characteristics of embryo quality and phase of development and transfer rates | 5 days |
| Clinical pregnancy rate | Clinical pregnancy rate | 5 days |
| Live birth rate | Live birth rate | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Adverse Events | Adverse events noted by the women that received IVF and INVOcell IVC | 5 days |
| Offspring adverse events | Adverse events noted for the offspring |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects that have received infertility treatment with either INVOcell IVC or standard IVF during the same timeframe. All subjects treated with the standard of care IVF method during the same timeframe that the center used INVOcell IVC were included in the retrospective data collection.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina Conceptions | Raleigh | North Carolina | 27607 | United States | ||
| Piedmont Reproductive Endocrinology Group |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| 5 days |
| Greenville |
| South Carolina |
| 29615 |
| United States |
| CARE Fertility | Bedford | Texas | 76022 | United States |
| THE NEW HOPE CENTER for Reproductive Medicine | Virginia Beach | Virginia | 23452 | United States |