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

March 3, 2025 updated by: Fairtility

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 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.
3 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 3 days
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
Time Frame: 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.
3 days
Blastocyst formation based on the CHLOE algorithm prediction for a subset of good/fair embryos
Time Frame: 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.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fairtility

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yossi Gilgun-Sherki, PhD, MBA, Head of Clinical and Regulatory Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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