Fertility DisordersNCT07464275
Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction
An observational study of Fertility Disorders and Infertility, run by Future Fertility Inc. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fertility Disorders, Infertility
- What is being tested?
- MAGENTA Blast
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- 22 Apr 2026to 25 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women undergoing fresh IVF treatment
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective, Observational, Multi-centered Study to Validate a D3-D5 Embryo Prediction Tool and Assess Its Performance in a Clinical Setting.
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.
Read the 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
- Fertility Disorders, Infertility
- Being tested
- MAGENTA Blast
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAGENTA BlastDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing fresh IVF treatment | Women undergoing fresh IVF treatment using their own eggs and are at least 18 years of age. Receives: Device: MAGENTA Blast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 3 days
Secondary outcomes (3)
The association between using MAGENTA Blast as an informative adjunctive aid and the prediction of blastocyst formation by Day 5 in all embryos
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.
Measured: 3 days
Blastocyst formation predicted by embryologists using traditional morphology only in all embryos as well as for the subset of embryos graded as Good/Fair
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.
Measured: 3 days
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
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start22 Apr 2026
- Primary completion25 May 2026
- Study completion25 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future Fertility Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464275
- Sponsor's protocol ID
- FF-BLAST-026-2026
- Status last verified
- May 2026
- First submitted
- 6 Mar 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Observational, Multi-centered Study to Validate a D3-D5 Embryo Prediction Tool and Assess Its Performance in a Clinical Setting.
- ClinicalTrials.gov ID
- NCT07464275
- Acronym / sponsor ID
- FF-BLAST-026-2026
- Conditions
- Fertility Disorders, Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Future Fertility Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 25 May 2026 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing fresh IVF treatment | – | Device: MAGENTA BlastWomen undergoing fresh IVF treatment using their own eggs and are at least 18 years of age. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing fresh IVF treatment
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAGENTA BlastMAGENTA 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. | Device | Women undergoing fresh IVF treatment |
Primary outcome
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.
3 secondary outcomes
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
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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Disorders and Infertility, run by Future Fertility Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.