Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation

Completed

• Conditions: Fertility Disorders

• Registration Number: NCT05455281
• Lead Sponsor: Fairtility

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-13
• Study Start: 2022-07-27
• Primary Completion: 2023-06-27
• Study Completion: 2023-07-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for a subset of good/fair embryos	3 days	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.

Secondary Outcome Measures

Name	Time	Method
The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for all embryos	3 days	The prediction of blastocyst outcome using CHLOE algorithm, and the actual blastocyst outcome for all embryos will be measured using odds ratio.
Blastocyst formation using traditional human morphology only for all embryos	3 days	The prediction of blastocyst outcome using traditional human morphology only, and the actual blastocyst outcome for all embryos will be measured using odds ratio.
Blastocyst formation based on the CHLOE algorithm prediction for a subset of good/fair embryos	3 days	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.

Trial Locations

Locations (3)

Hadassah University Hospital; 🇮🇱 Jerusalem, Israel

IVF Florida; 🇺🇸 Margate, Florida, United States

Mayo clinic; 🇺🇸 Rochester, Minnesota, United States