A Study to Evaluate the Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation in Women Undergoing IVF [Cultivating Human Life Through Optimal Embryos]

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot, Observational, Prospective Study to Evaluate the Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation in Women Undergoing In-vitro Fertilization

Conditions
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Fertility Disorders

Intervention / Treatment
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* Device: CHLOE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing fresh IVF treatment using their own eggs At least 18 years of age Total antral follicle count (AFC) of at least 12 as measured by ultrasound prior to stimulation (in cases where AFC is performed) Basal day 3 follicle-stimulating hormone levels (FSH) < 10 IU At least 8 normally fertilized eggs at pronuclear (2PN) stage Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm At least 2 cells embryo At least part of the embryos were cultured until Day 5 (i.e., 114-116 hours) IVF treatment cycles were performed during 2020-2021 Exclusion Criteria: Use of re-inseminated eggs Embryos that underwent day 3 biopsy for preimplantation genetic testing (PGT) Gestational carriers Concurrent participation in another clinical study Previous enrollment in this clinical study (i.e., previous cycles of the same women) History of cancer Embryos that underwent biopsy at cleavage stage

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CHLOE|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |