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Women under 42 years of age with at least two early-stage blastocysts on day 5 were randomized to either the control arm, using standard morphological assessment, or the study arm, employing a deep learning algorithm, intelligent Data Analysis Score (iDAScore), for embryo selection. The primary endpoint was a clinical pregnancy rate with a noninferiority margin of 5%. The trial included 1,066 patients (533 in the iDAScore group and 533 in the morphology group). The iDAScore group exhibited a clinical pregnancy rate of 46.5% (248 of 533 patients), compared to 48.2% (257 of 533 patients) in the morphology arm (risk difference \u22121.7%; 95% confidence interval \u22127.7, 4.3;\n                    <jats:italic>P<\/jats:italic>\n                    \u2009=\u20090.62). This study was not able to demonstrate noninferiority of deep learning for clinical pregnancy rate when compared to standard morphology and a predefined prioritization scheme. Australian New Zealand Clinical Trials Registry (ANZCTR) registration:\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.anzctr.org.au\/TrialSearch.aspx#&amp;&amp;conditionCode=&amp;dateOfRegistrationFrom=&amp;interventionDescription=&amp;interventionCodeOperator=OR&amp;primarySponsorType=&amp;gender=&amp;distance=&amp;postcode=&amp;pageSize=20&amp;ageGroup=&amp;recruitmentCountryOperator=OR&amp;recruitmentRegion=&amp;ethicsReview=&amp;countryOfRecruitment=&amp;registry=&amp;searchTxt=379161&amp;studyType=&amp;allocationToIntervention=&amp;dateOfRegistrationTo=&amp;recruitmentStatus=&amp;interventionCode=&amp;healthCondition=&amp;healthyVolunteers=&amp;page=1&amp;conditionCategory=&amp;fundingSource=&amp;trialStartDateTo=&amp;trialStartDateFrom=&amp;phase=\">379161<\/jats:ext-link>\n                    .\n                  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C.V. has received consulting fees, lecture payments and travel expenses from pharmaceutical firms with a commercial portfolio in IVF, and has previously (until June 2022) held shares in Virtus Health, a commercial IVF company. D.K.G. has received a research grant from Vitrolife to develop culture medium. S.M.N. has received consulting fees, lecture payments and travel expenses from pharmaceutical firms with a commercial portfolio in IVF. J.B. and M.G.L. are employees of Vitrolife and own shares in Vitrolife, who have a pending iDAScore patent. R.L.K. has received a grant from a pharmaceutical firm with a commercial portfolio in IVF, has received speaking fees and travel expenses from Vitrolife, who have a pending iDAScore patent. R.L. has received lecture payments and travel expenses from pharmaceutical firms with a commercial portfolio in IVF. M.M. has received lecture payments and travel expenses from pharmaceutical firms with a commercial portfolio in IVF and has previously (until June 2022) held shares in Virtus Health, a commercial IVF company. H.P. and B.T. are employed by a company where Vitrolife funded research. T.H. was previously employed by Vitrolife, who have a pending iDAScore patent. The other authors declare no competing interests.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}