Pivotal Observational CHLOE Study

NCT06111365 | Completed FDA Device

• 1 other identifier: FRT-02-22
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

IVF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

IVF

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

Device: CHLOE

Interventions

CHLOE DEVICE

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

IVF

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women undergoing fresh IVF treatment using their own eggs or donor eggs
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Women undergoing fresh IVF treatment using their own eggs or donor eggs.
• Women at least 18 years of age; in case of a donor egg the donor shall be at least 18.
• Total antral follicle count (AFC) of at least 12 as measured by ultrasound prior to stimulation (in cases where AFC is performed).
• Basal follicle-stimulating hormone (FSH) level \< 10 IU or AMH \> 1.2 ng/ml
• At least 8 normally fertilized eggs at bipronuclear (2PN) stage in this in-vitro fertilization cycle.
• Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
• At least 2 cells embryo.
• 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.

You may not qualify if:

• 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
• Use of re-inseminated eggs
• Embryos that underwent day 3 biopsy for preimplantation genetic testing (PGT)
• Embryos that underwent biopsy at cleavage stage
• Non-2PN embryos
• 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)

Sponsors & Collaborators

• Fairtility: lead

Study Sites (3)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Cleveland Clinic Fertility

Cleveland, Ohio, 44147, United States

Location

Dallas Fertility Center

Dallas, Texas, 75231, United States

Location

Study Design

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

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 1, 2023
• Study Start: January 22, 2024
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)