Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction
NCT07464275 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80
Last updated 2026-05-05
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
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.
Sponsors & Collaborators
-
Future Fertility Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-22
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
- FDA Device
- Yes
Countries
- Canada
Study Locations
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