Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation (CHLOE)

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

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.

Study Overview

• Status: Completed
• Conditions: Fertility Disorders
• Intervention / Treatment: Device: CHLOE

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 Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 12000
    • Hadassah University Hospital
• United States
  • Florida
    • Margate, Florida, United States, 33063
      • IVF Florida
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Women undergoing fresh IVF treatment

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fairtility
• Investigators: Study Director: Yossi Gilgun-Sherki, PhD, MBA, Head of Clinical and Regulatory Affairs

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2022
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): July 27, 2023

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: FRT-01-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study protocol and Statistical Analysis Plan (SAP) will be shared
• IPD Sharing Time Frame: Once study will be completed.
• IPD Sharing Access Criteria: Once study will be completed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No