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Completed

NCT Number: NCT07464275

Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction

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.

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Key information

Conditions

Fertility Disorders Genital Diseases Infertility Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Future Fertility

Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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

    Time frame: 3 days

    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.

Secondary outcomes

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

    Time frame: 3 days

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

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

    Time frame: 3 days

    The predictions of blastocyst formation by day 5 using traditional morphology only and the observed blastocyst outcomes (Yes/No) for all embryos as well as for the subset of embryos graded as Good/Fair, will be quantified using Odds Ratio (OR) greater than 1 and corresponding 95% confidence intervals.

  3. 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

    Time frame: 3 days

    The predictions for blastocyst formation for each individual embryologist using traditional morphology with adjunctive MAGENTA Blast in embryos graded as Good/Fair and the observed blastocyst outcome (Yes/No), will be measured using Odds Ratio (OR) greater than 1 and corresponding 95% confidence intervals.

Sponsors and collaborators

Lead sponsor

Future Fertility Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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