CompletedNot Applicable

Pivotal Observational CHLOE Study

United States59 participantsStarted 2024-01-22

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

The Odds Ratio (OR) for the adjunct prediction of blastulation is required to be statistically significantly greater than 1

Timeframe: day 5

Trial details

NCT IDNCT06111365

SponsorFairtility

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-08-12

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