Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation

NCT05455281 | Completed FDA Device

• 1 other identifier: FRT-01-22
• Study Type: observational
• Target: 55
• Locations: 2 countries
• Sites: 3

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.

Conditions

Fertility Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for all embryos

  3 days

• Blastocyst formation using traditional human morphology only for all embryos

  3 days

• Blastocyst formation based on the CHLOE algorithm prediction for a subset of good/fair embryos

  3 days

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women undergoing IVF
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women undergoing fresh IVF treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fairtility: lead

Study Sites (3)

IVF Florida

Margate, Florida, 33063, United States

Location

Mayo clinic

Rochester, Minnesota, 55905, United States

Location

Hadassah University Hospital

Jerusalem, 12000, Israel

Location

Study Officials

• Yossi Gilgun-Sherki, PhD, MBA

  Head of Clinical and Regulatory Affairs

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 13, 2022
• Study Start: July 27, 2022
• Primary Completion: June 27, 2023
• Study Completion: July 27, 2023
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); US (2)