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NOT YET RECRUITING
NCT07464275

Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction

Sponsor: Future Fertility Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2026-03

Completion Date

2026-06

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DEVICE

MAGENTA Blast

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.