Trials / Not Yet Recruiting
Not Yet RecruitingNCT07464275
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.
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (estimated)
- Sponsor
- Future Fertility Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2026-03-11
- Last updated
- 2026-03-12
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07464275. Inclusion in this directory is not an endorsement.