Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation

NCT ID: NCT05455281

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-27

Study Completion Date

2023-07-27

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.

Conditions

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Fertility Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fairtility

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yossi Gilgun-Sherki, PhD, MBA

Role: STUDY_DIRECTOR

Head of Clinical and Regulatory Affairs

Locations

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IVF Florida

Margate, Florida, United States

Site Status

Mayo clinic

Rochester, Minnesota, United States

Site Status

Hadassah University Hospital

Jerusalem, , Israel

Site Status

Countries

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United States Israel

Other Identifiers

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FRT-01-22

Identifier Type: -

Identifier Source: org_study_id

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