RecruitingNot ApplicableNCT07187934

EVALUATION OF A FULLY AUTOMATED AI TOOL FOR EMBRYO RANKING

PROSPECTIVE EVALUATION OF THE IDASCORE ALGORITHM FOR EMBRYO RANKING

Sponsor

Universitair Ziekenhuis Brussel

Enrollment

1,325 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

Pregnancy

Summary

This study aims to investigate whether embryo ranking by a fully automated AI tool (iDAScore) results in a similar transfer-to-pregnancy compared to manual embryo ranking by an embryologist. IVF patients who are planned for a freeze-all approach (where all usable embryos are frozen and transferred in later transfer cycles) will be allocated to either the control (ranking by embryologist) or intervention arm (ranking by iDAScore). The frozen embryos will be warmed and transferred one by one, according to their assigned rank. We want to see if the average number of embryo transfers that is needed to achieve a clinical pregnancy (transfer-to-pregnancy) is similar in both groups.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 42 Years

Inclusion Criteria7

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
≤ Age ≤ 42 years
≤ BMI ≤ 35 kg/m²
Maximum third IVF/ICSI cycle
Participants can be included only once in the trial

Exclusion Criteria6

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

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Interventions

DEVICEAI 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).