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| ID | Type | Description | Link |
|---|---|---|---|
| TST-1736-p | Other Identifier | Auxogyn, Inc. |
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The purpose of this study is to demonstrate that the Eevaâ„¢ System is compatible with the Eeva 12-well Dish.
This study is designed to demonstrate that the Eeva System Software successfully tracks the embryo images and identifies the timing of key developmental events using the Eeva 12-well Dish.
This is a prospective, observational, blinded, single arm, nonrandomized, single center clinical study. Images of developing embryos and Eeva predictions will be blinded to embryologists and physicians
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women undergoing IVF treatment | Women undergoing IVF treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-vitro fertilization using Eeva | Device | Eeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva results along with traditional morphological grading to assist in selecting embryo(s) for transfer or freezing. |
| Measure | Description | Time Frame |
|---|---|---|
| To validate and develop the Eeva Software. | The clinical image data (embryos images) will be used to develop the Eeva System Software. The Eeva software validation will consist in comparing the specificity of the Eeva System Software Blastocyst Prediction from the Eeva 12-well Dish to the specificity of the Eeva System Software from the Eeva 25-well Dish (the specificity of the Eeva System Software from the Eeva 25-well Dish was previously determined during the Eeva System Study TST-1788-r). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity and sensitivity and 95% confidence intervals of the Eeva System Software and the Embryologist Panel (also referred to as Panel) measurements will be computed. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The postive/negative (in-window/out-window) agreement of the Eeva Software and Panel measurements will be compared. | 3 months | |
| The Mean Absolute Difference (MAD) will be calculated between each observer (Eeva Software, Panelist 1, Panelist 2, and Panelist 3) |
Inclusion Criteria:
Exclusion Criteria:
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Women in the United States who undergo IVF treatment
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| Name | Affiliation | Role |
|---|---|---|
| Robert Boostanfar, MD | HRC Fertility | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HRC Fertility | Encino | California | 91436 | United States |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| 3 months |
| Bland Altman plots for the differences between each observer. | 3 months |