Fertility Disorders, Infertility
Conditions
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.
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.
Interventions
DEVICEMAGENTA 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
Future Fertility Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 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. |
| 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 | 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. |
Countries
Canada
Outcome results
None listed