Pivotal Observational CHLOE Study

A Pivotal, Observational, Prospective Assessment Study to Assess the Performance of Fairtility CHLOE BLAST™ Algorithm for the Prediction of Blastocyst Formation in Women Undergoing In-vitro Fertilization

This pivotal study is an observational, prospective assessment, multi-center, databank based, clinical study aimed to evaluate the performance of CHLOE™ algorithm in prediction of blastocyst formation.

Study Overview

• Status: Completed
• Conditions: IVF
• Intervention / Treatment: Device: CHLOE

Detailed Description

This pivotal study is an observational, prospective assessment, multi-center, databank based, clinical study aimed to evaluate the performance of CHLOE™ algorithm in prediction of blastocyst formation.

Day 3 morphological grading will be performed by three clinical embryologists (hereafter "Assessors"), who will use standard embryo grading assessment techniques and will be blinded to the CHLOE™ information and to the actual blastocyte status (Yes/No).

Five independent embryologists (hereafter "Panelists") who will be masked to imaging data, to actual blastocyst status, and to each other evaluations will be provided with the morphological grading information performed earlier by the 3 assessors and with the age of subject or egg donor. All data will be presented to Panelists as full cohorts of embryos for each mother. Then they will provide their prediction on blastocyst status of each embryo twice: once the prediction will be based on morphology only and once on morphology plus CHLOE™ assigned score ("High", "Medium+", "Medium-", or "Low"). The two assessments will be done with a washout period of at least 2 weeks and no information will be provided to link the two assessments.

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44147
      • Cleveland Clinic Fertility
  • Texas
    • Dallas, Texas, United States, 75231
      • Dallas Fertility Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Women undergoing fresh IVF treatment using their own eggs or donor eggs

Description

Inclusion Criteria:

1. Women undergoing fresh IVF treatment using their own eggs or donor eggs.
2. Women at least 18 years of age; in case of a donor egg the donor shall be at least 18.
3. Total antral follicle count (AFC) of at least 12 as measured by ultrasound prior to stimulation (in cases where AFC is performed).
4. Basal follicle-stimulating hormone (FSH) level < 10 IU or AMH > 1.2 ng/ml
5. At least 8 normally fertilized eggs at bipronuclear (2PN) stage in this in-vitro fertilization cycle.
6. Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
7. At least 2 cells embryo.
8. Embryos were cultured in a Embryoscope ES-D (i.e., EmbryoScope model D - 6 spaces for patients, 12 wells each, resolution - 500*500). The EmbryoScope was configured to the default values provided by EmbryoScope manufacturer.

Exclusion Criteria:

1. Gestational carriers
2. Concurrent participation in another clinical study
3. Previous enrollment in this clinical study (i.e., previous cycles of the same women)
4. History of cancer
5. Use of re-inseminated eggs
6. Embryos that underwent day 3 biopsy for preimplantation genetic testing (PGT)
7. Embryos that underwent biopsy at cleavage stage
8. Non-2PN embryos
9. Embryos with video frames in which the embryo is not clearly visible. Namely, videos with empty well, Bad Focus, Cropped Embryo, Air Bubble (see Annotation protocol, embryos with "Technical Errors" states)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IVF; Women undergoing fresh IVF treatment using their own eggs or donor eggs	Device: CHLOE; the system will provide to the user a "CHLOE™ score", which is a blastocyst development prediction value, a discrete grading for blastocyst associated with the likelihood of the embryo reaching the blastocyst stage at Day 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Odds Ratio (OR) for the adjunct prediction of blastulation is required to be statistically significantly greater than 1	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.	day 5

Secondary Outcome Measures

Outcome Measure	Time Frame
The Odds Ratio (OR) for predicting blastocyst formation based on adjunct prediction with CHLOE for all embryos	Day 5
The Odds Ratio (OR) for predicting blastocyst formation using traditional morphology only	Day 5
The Odds Ratio (OR) for Good/Fair embryos predicting blastocyst formation for each individual embryologist	Day 5
Embryo level diagnostic performance measures (Specificity, Sensitivity, Negative predictive value (NPV), Positive predictive value (PPV), Negative likelihood ratio, Positive likelihood ratio)	Day 5

Collaborators and Investigators

• Sponsor: Fairtility

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Actual): August 12, 2024
• Study Completion (Actual): August 12, 2024

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 15, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: FRT-02-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data will be used for this research only

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