Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction

A Retrospective, Observational, Multi-centered Study to Validate a D3-D5 Embryo Prediction Tool and Assess Its Performance in a Clinical Setting.

This is a retrospective, observational, single-arm, multi-center study to evaluate the predictive performance of MAGENTA BLAST, an artificial intelligence (AI)-enabled software application, when used as analytical, adjunctive information to support Day 3 cleavage stage embryo predictions of blastocyst formation by Day 5.

This retrospective, observational, single-arm, multi-centered study is designed to evaluate the predictive performance of MAGENTA Blast, an AI-enabled software, as adjunctive information to support Day 3 cleavage-stage embryo predictions of blastocyst formation by Day 5. The study will assess the association between embryo-level predictions generated using standard morphological evaluation with and without adjunctive MAGENTA Blast output, and observed blastocyst formation outcomes.

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 (in cases where basal day 3 FSH is performed)
• At least 8 normally fertilized eggs at the pronuclear (2PN) stage
• Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm
• At least one two-cell embryo on Day 3
• At least part of the embryo cohort is cultured until day 5 (i.e. 114-116 HPI)

Exclusion Criteria:

• Use of re-inseminated eggs (rescue ICSI)
• Gestational carriers
• Concurrent participation in another clinical study
• Previous enrollment in this clinical study (i.e., one cycle data per patient)
• History of cancer
• Planned Day 3 laser-assisted hatching or embryos that underwent Day 3 biopsy for preimplantation genetic testing (PGT)
• Low quality images
• Lack of correlating reproductive outcomes (IVF lab results not available)