CompletedNot Applicable

Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation

United States, Israel55 participantsStarted 2022-07-27

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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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

What they're measuring

The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for a subset of good/fair embryos

Timeframe: 3 days

Trial details

NCT IDNCT05455281

SponsorFairtility

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-06-27

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