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This is an observational, prospective, single-arm, multi-center, clinical study to evaluate the performance of CHLOE, an Artificial Intelligence (AI)-based software application, as adjunct information to support identifying embryos on Day 3 that are most likely to form blastocysts.
The study is an observational, prospective, single-arm, multi-center, clinical study in order to evaluate the performance of CHLOE, an Artificial Intelligence (AI)-based software application, as adjunct information to support identifying embryos on Day 3 that are most likely to form blastocysts on Day 5.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHLOE | Device | CHLOE is designed to automatically analyze events related to embryo development from Time Lapse Incubator (TLI) images and provide prediction on the likelihood of embryos developing to the blastocyst. This information can assist embryologists and IVF professionals in the selection of the most viable embryo for transfer or freezing, when there are multiple embryos deemed suitable. |
| Measure | Description | Time Frame |
|---|---|---|
| The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for a subset of good/fair embryos | The prediction of blastocyst outcome using CHLOE algorithm, and the actual blastocyst outcome for a subset of good/fair embryos will be measured using odds ratio. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for all embryos | The prediction of blastocyst outcome using CHLOE algorithm, and the actual blastocyst outcome for all embryos will be measured using odds ratio. | 3 days |
| Blastocyst formation using traditional human morphology only for all embryos |
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Inclusion Criteria:
Exclusion Criteria:
Women undergoing IVF
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Women undergoing fresh IVF treatment
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| Name | Affiliation | Role |
|---|---|---|
| Yossi Gilgun-Sherki, PhD, MBA | Head of Clinical and Regulatory Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVF Florida | Margate | Florida | 33063 | United States | ||
| Mayo clinic |
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The prediction of blastocyst outcome using traditional human morphology only, and the actual blastocyst outcome for all embryos will be measured using odds ratio. |
| 3 days |
| Blastocyst formation based on the CHLOE algorithm prediction for a subset of good/fair embryos | The prediction of blastocyst outcome using the CHLOE algorithm for each individual embryologist will be measured using odds ratio for a subset of good/fair embryos. | 3 days |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Hadassah University Hospital | Jerusalem | 12000 | Israel |