Pivotal Observational CHLOE Study

Completed

Conditions studied: IVF

In brief

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.

Key facts

Study ID

NCT06111365

Run by

Fairtility

People needed

59

Starts

2024-01-22

Expected to finish

2024-08-12

Last updated by the study team

2025-03-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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)

Where it is running

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

Full record on ClinicalTrials.gov

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