EVALUATION OF A FULLY AUTOMATED AI TOOL FOR EMBRYO RANKING
NCT ID: NCT07187934
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1325 participants
INTERVENTIONAL
2025-12-11
2029-10-01
Brief Summary
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Detailed Description
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In the control group, the embryologist manually ranks all freezable embryos according to the assigned Gardner scores, applying a standard prioritization scheme: day of cryopreservation \> expansion stage \> TE score \> ICM score.
If multiple embryos share the same Gardner score, the embryologist looks at the full morphokinetics to establish a final ranking. The order of warming for subsequent frozen embryo transfer (FET) cycles follows this ranking: the embryo ranked 1 is transferred first. If no clinical pregnancy results, the embryo ranked 2 is transferred in the next FET cycle, and so on.
In the study group, the iDA score is retrieved for each freezable embryo. Embryos are ranked solely based on their iDA score, with the highest score assigned rank 1, and so on. The order of warming for subsequent FET cycles is determined exclusively by this ranking. As in the embryologist group, the embryo ranked 1 is transferred first, followed by rank 2 in case of no clinical pregnancy, and so on.
+/- 10 days after embryo transfer, an hCG blood test is performed. In case of a positive result, the pregnancy is monitored until the 7-week ultrasound, at which the presence of fetal heartbeat confirms a clinical pregnancy. Patients are followed for clinical pregnancy outcomes of FETs performed up to one year after oocyte retrieval, or until the pregnancy outcome of the last available embryo is known.
In both the study and control arm, all procedures follow the standard of care. The only difference between the groups is the method of embryo ranking-and therefore the order in which embryos will be transferred.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Embryologist ranking
Embryologist ranks the embryos according to their appearance
No interventions assigned to this group
iDA ranking
AI tool ranks embryos based on fully automated analysis of time-lapse images
AI algorithm
iDAScore® is a deep learning-based tool that provides fully automated analysis of embryo time-lapse images. It automatically generates a score (1-9.9) for each embryo in the patient's embryo cohort, which correlates to the likelihood of achieving a fetal heartbeat (clinical pregnancy).
Interventions
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AI algorithm
iDAScore® is a deep learning-based tool that provides fully automated analysis of embryo time-lapse images. It automatically generates a score (1-9.9) for each embryo in the patient's embryo cohort, which correlates to the likelihood of achieving a fetal heartbeat (clinical pregnancy).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
42 Years
FEMALE
Yes
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Principal Investigators
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Julie Praet, M.D.
Role: PRINCIPAL_INVESTIGATOR
Brussels IVF, UZ Brussel
Locations
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Brussels IVF, UZ Brussel
Brussels, Brussels Capital, Belgium
Countries
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Central Contacts
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Facility Contacts
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Elsie Nulens, MSc
Role: primary
Tine Bosman, MSc
Role: backup
Related Links
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Other Identifiers
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PRIDE_2025
Identifier Type: -
Identifier Source: org_study_id