Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation

A Pilot, Observational, Prospective Study to Evaluate the Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation in Women Undergoing In-vitro Fertilization

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.

The study is an observational, prospective, single-arm, multi-center, clinical study in order 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 on Day 5.

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