Automated AI ranking of embryos with iDAScore
PROSPECTIVE EVALUATION OF THE IDASCORE ALGORITHM FOR EMBRYO RANKING
This will test whether an automated AI tool called iDAScore can rank frozen embryos as well as an embryologist for IVF patients using a freeze-all approach.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1325 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | Female |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Brussels, Brussels Capital) |
| Trial ID | NCT07187934 on ClinicalTrials.gov |
What this trial studies
IVF/ICSI patients planned for a freeze-all protocol who produce at least two vitrifiable blastocysts are randomized to embryo ranking by an embryologist or by the iDAScore AI. Embryos are cultured in an EmbryoScope+ time-lapse incubator, vitrified on day 5 (or day 6 if needed), and then warmed and transferred one by one in frozen embryo transfer cycles according to their assigned rank. The control group uses manual ranking based on Gardner criteria and full morphokinetics, while the study group uses the iDAScore to order embryos. The primary outcome is transfer-to-pregnancy, measured as the average number of transfers needed to achieve a clinical pregnancy.
Who should consider this trial
Good fit: Ideal candidates are IVF/ICSI patients aged 18–42 with BMI 18–35 planned for a day-5 freeze-all approach who produce at least two blastocysts that meet cryopreservation criteria.
Not a fit: Patients ineligible for the protocol—such as those using preimplantation genetic testing, frozen oocytes, in vitro maturation cycles, with proven untreated intra-uterine pathologies or endometriosis stage 3–4, or those treated outside the Brussels site—would not be expected to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could standardize embryo selection, reduce variability between embryologists, and decrease the number of transfer cycles needed to achieve pregnancy.
How similar studies have performed: Retrospective studies and pilot reports of AI embryo-ranking tools, including iDAScore, have shown promising correlations with implantation but prospective randomized evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients undergoing an ICSI/IVF treatment (with donor or own oocytes) that are planned for a 'freeze-all' strategy on day 5 * all types of sperm samples (ejaculated or testicular, fresh or frozen, partner or donor origin) * Minimum 8 follicles (≥ 12 mm) on last follicular measurement before oocyte retrieval * 18 ≤ Age ≤ 42 years * 18 ≤ BMI ≤ 35 kg/m² * Maximum third IVF/ICSI cycle * Participants can be included only once in the trial Exclusion Criteria: * Embassy patients * Use of frozen oocytes * In vitro maturation (IVM) cycles * Pre-implantation genetic Testing (PGT) cycles * Proven untreated intra-uterine pathologies (e.g. Asherman syndrome, adenomysosis) * Endometriosis stage 3/4
Where this trial is running
Brussels, Brussels Capital
- Brussels IVF, UZ Brussel — Brussels, Brussels Capital, Belgium (Recruiting)
Study contacts
- Principal investigator: Julie Praet, M.D. — Brussels IVF, UZ Brussel
- Study coordinator: Elsie Nulens
- Email: elsie.nulens@uzbrussel.be
- Phone: +32 2 477 66 48
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.