Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation

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Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Fertility Disorders

Interventions

CHLOEDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

IVF Florida

Margate, Florida, United States

Mayo clinic

Rochester, Minnesota, United States

Hadassah University Hospital

Jerusalem, Israel

Outcomes

Primary Outcomes

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.

Time frame: 3 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 3 days

Data from ClinicalTrials.gov

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