[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607390":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":41,"studyPopulation":30,"armGroups":42,"interventions":53,"overallOfficials":61,"centralContacts":66,"locations":76,"responsibleParty":97,"collaborators":30,"id":99,"slug":30,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":30,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":78,"whyStopped":30,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Universitair Ziekenhuis Brussel","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Transfer to pregnancy","Number of embryo transfers performed until a clinical pregnancy is obtained","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.",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"iDA-embryologist consensus","In how many cases do iDA and the embryologist prioritize the same embryo for the first embryo transfer?","Embryo ranking is done on day 5 and\u002For 6 of embryo development and can be immediately compared during ranking.",{"measure":19,"description":20,"timeFrame":21},"Embryo prioritization time","How long does it take to establish a ranking of all embryos from that cohort?","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.",{"measure":23,"description":24,"timeFrame":25},"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","Up until 1 year after oocyte retrieval",{"measure":27,"description":28,"timeFrame":29},"Clinical pregnancy rate after the first embryo transfer","Number of clinical pregnancies divided by number of embryo transfers performed","Clinical pregnancy is determined at the 7 week echo by detection of a fetal heart beat.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"RANDOMIZED","PARALLEL","Randomisation (1:1) based on a computer-generated randomisation list with block size 10.","DIAGNOSTIC",{"masking":37,"maskingDescription":30,"whoMasked":38},"DOUBLE",[39,40],"PARTICIPANT","CARE_PROVIDER","The study population consists of IVF\u002FICSI patients scheduled for a freeze-all policy on day 5. Inclusion takes place on the day prior to oocyte retrieval, based on predefined inclusion criteria. Embryo culture is performed in an EmbryoScope+ time-lapse incubator. On day 5 of embryo development, the embryologist evaluates the embryos using the Gardner criteria, assessing expansion stage, inner cell mass (ICM), and trophectoderm (TE). All embryos meeting our in-house cryopreservation criteria are vitrified. Embryos not yet meeting the criteria remain in culture and are re-evaluated on day 6. Once at least two blastocysts meet the cryopreservation criteria on day 5 and\u002For day 6, the patient is randomized in the control or study arm.\n\nIn 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.\n\nIf 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.\n\nIn 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.\n\n+\u002F- 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.\n\nIn 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.",[43,47],{"label":44,"type":45,"description":46,"interventionNames":30},"Embryologist ranking","NO_INTERVENTION","Embryologist ranks the embryos according to their appearance",{"label":48,"type":49,"description":50,"interventionNames":51},"iDA ranking","EXPERIMENTAL","AI tool ranks embryos based on fully automated analysis of time-lapse images",[52],"Device: AI algorithm",[54],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"DEVICE","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).",[48],[60],"iDAScore",[62],{"name":63,"affiliation":64,"role":65},"Julie Praet, M.D.","Brussels IVF, UZ Brussel","PRINCIPAL_INVESTIGATOR",[67,72],{"name":68,"role":69,"phone":70,"phoneExt":30,"email":71},"Elsie Nulens","CONTACT","+32 2 477 66 48","elsie.nulens@uzbrussel.be",{"name":73,"role":69,"phone":74,"phoneExt":30,"email":75},"Tine Bosman, Msc","+3224774049","tine.bosman@uzbrussel.be",[77],{"facility":64,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"RECRUITING","Brussels","Brussels Capital","1090","Belgium","BE",{"type":85,"coordinates":86},"Point",[87,88],4.34878,50.85045,{"lat":88,"lon":87},[91,94],{"name":92,"role":69,"phone":70,"phoneExt":30,"email":93},"Elsie Nulens, MSc","Elsie.Nulens@uzbrussel.be",{"name":95,"role":69,"phone":96,"phoneExt":30,"email":75},"Tine Bosman, MSc","+32 2 477 40 49",{"type":98,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100607390",false,"NCT07187934","EVALUATION OF A FULLY AUTOMATED AI TOOL FOR EMBRYO RANKING","PROSPECTIVE EVALUATION OF THE IDASCORE ALGORITHM FOR EMBRYO RANKING","PRIDE","Inclusion Criteria:\n\n* patients undergoing an ICSI\u002FIVF treatment (with donor or own oocytes) that are planned for a 'freeze-all' strategy on day 5\n* all types of sperm samples (ejaculated or testicular, fresh or frozen, partner or donor origin)\n* Minimum 8 follicles (≥ 12 mm) on last follicular measurement before oocyte retrieval\n* 18 ≤ Age ≤ 42 years\n* 18 ≤ BMI ≤ 35 kg\u002Fm²\n* Maximum third IVF\u002FICSI cycle\n* Participants can be included only once in the trial\n\nExclusion Criteria:\n\n* Embassy patients\n* Use of frozen oocytes\n* In vitro maturation (IVM) cycles\n* Pre-implantation genetic Testing (PGT) cycles\n* Proven untreated intra-uterine pathologies (e.g. Asherman syndrome, adenomysosis)\n* Endometriosis stage 3\u002F4",true,"FEMALE","18 Years","42 Years",{"count":111,"type":112},1325,"ESTIMATED","INTERVENTIONAL",[115],"NA","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.",[118],"Pregnancy",[120,121,122,123,124],"iDA","AI","embryo ranking","transfer-to-pregnancy","time-lapse","2025-12-16",{"date":127,"type":128},"2025-12-23","ACTUAL",{"date":130,"type":128},"2025-12-11",{"date":132,"type":112},"2029-10-01",{"name":5,"class":6},1]