Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction

NCT07464275 | Completed DMC FDA Device

• 1 other identifier: FF-BLAST-026-2026
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fertility Disorders; Infertility

Outcome Measures

Primary Outcomes (1)

• The association between using MAGENTA Blast as an informative adjunctive aid and the prediction of blastocyst formation by Day 5 in embryos graded as Good/Fair

  The association between blastocyst outcome predictions by Day 5 with adjunctive use of MAGENTA Blast and the observed blastocyst outcome (Yes/No) for embryos classified as Good/Fair quality will be quantified using Odds Ratio (OR) greater than 1 and corresponding 95% confidence intervals.

  3 days

Secondary Outcomes (3)

• The association between using MAGENTA Blast as an informative adjunctive aid and the prediction of blastocyst formation by Day 5 in all embryos

  3 days

• Blastocyst formation predicted by embryologists using traditional morphology only in all embryos as well as for the subset of embryos graded as Good/Fair

  3 days

• The association per embryologist between adjunctive use of MAGENTA Blast for Day 3 cleavage-stage embryo assessment and prediction of blastocyst formation by Day 5 in embryos graded as Good/Fair

  3 days

Study Arms (1)

Women undergoing fresh IVF treatment

Women undergoing fresh IVF treatment using their own eggs and are at least 18 years of age.

Device: MAGENTA Blast

Interventions

MAGENTA Blast DEVICE

MAGENTA Blast is an AI-enabled software as a medical device (SaMD) that analyzes Day 3 embryo images or time-lapse sequences to provide adjunctive information on events occurring during embryo development that may predict further development to the blastocyst stage by Day 5. The device is intended to provide adjunctive decision support to embryologists when selecting embryos for transfer on Day 3, continued culture, or cryopreservation, in situations where, following standard morphological assessment, multiple embryos are deemed suitable.

Women undergoing fresh IVF treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women undergoing fresh IVF treatment

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Future Fertility Inc.: lead

Study Sites (1)

Future Fertility

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 11, 2026
• Study Start: April 22, 2026
• Primary Completion: May 25, 2026
• Study Completion: May 25, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)