EVALUATION OF A FULLY AUTOMATED AI TOOL FOR EMBRYO RANKING
ConditionPregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorUniversitair Ziekenhuis Brussel
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Embassy patients
Use of frozen oocytes
In vitro maturation (IVM) cycles
Pre-implantation genetic Testing (PGT) cycles
Trial design
Design model
Parallel
Treatments tested in this trial
AI algorithm
DeviceiDAScore® 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).
Treatment groups
1,325 Participants
are divided into 2 treatment groupsGroup A: Embryologist rankingNo intervention 0 interventions
Group B: iDA rankingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Transfer to pregnancy
Number of embryo transfers performed until a clinical pregnancy is obtained
Time frame
The patient is followed up for clinical pregnancy outcomes (7-week echo) up until 1 year after the oocyte retrieval date, or until the result of the last available embryo is known.Secondary outcomes
1
iDA-embryologist consensus
In how many cases do iDA and the embryologist prioritize the same embryo for the first embryo transfer?
Time frame
Embryo ranking is done on day 5 and/or 6 of embryo development and can be immediately compared during ranking.2
Embryo prioritization time
How long does it take to establish a ranking of all embryos from that cohort?
Time frame
Measures the time elapsing between the start and end of embryo prioritisation (range of minutes). Is recorded on day 5 and day 6 of embryo development right after embryo evaluation.3
Cumulative clinical pregnancy rate
Number of oocyte retrievals resulting in at least one clinical pregnancy within 1 year of the oocyte retrieval divided by total number of oocyte retrievals
Time frame
Up until 1 year after oocyte retrieval4
Clinical pregnancy rate after the first embryo transfer
Number of clinical pregnancies divided by number of embryo transfers performed
Time frame
Clinical pregnancy is determined at the 7 week echo by detection of a fetal heart beat.Sponsors and contacts
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Source ClinicalTrials.gov