Publication:
Clinical validation of embryo prognostic tests; determining predictive value: phase 2

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dc.contributor.coauthorPirtea, Paul (56737504800)
dc.contributor.coauthorSu, Irene H. (60142506600)
dc.contributor.coauthorFrisk Toft, Christian Liebst (60142539200)
dc.contributor.coauthorKalafat, Erkan (56388776400)
dc.date.accessioned2025-12-31T08:19:54Z
dc.date.available2025-12-31
dc.date.issued2025
dc.description.abstractClinical prognostic and diagnostic tests should be safe and effective. Tests that predict the competence of embryos to implant and progress to a live birth or an offspring without an inherited genetic condition are no different. However, tests performed on human embryos can be more challenging to validate than virtually any other group of clinical tests. Understanding those challenges is the key to designing and implementing an effective validation paradigm for clinical embryo testing. This manuscript details the methodology of performing clinical validation of embryo tests. The manuscript covers the concepts and differences of prognostic and diagnostic tests, mosaicism, choice of endpoint measures, what study design to use, sample size calculation, patient cohorts, the importance of blinding, and data analysis and interpretation. Preimplantation genetic tests are used as an example because of widespread use. © 2025 Elsevier B.V., All rights reserved.
dc.description.fulltextYes
dc.description.harvestedfromManual
dc.description.indexedbyScopus
dc.description.indexedbyPubMed
dc.description.publisherscopeInternational
dc.description.readpublishN/A
dc.description.sponsoredbyTubitakEuN/A
dc.identifier.doi10.1016/j.fertnstert.2025.08.011
dc.identifier.eissn1556-5653
dc.identifier.embargoNo
dc.identifier.endpage848
dc.identifier.issn0015-0282
dc.identifier.issue5P1
dc.identifier.pubmed41106952
dc.identifier.quartileN/A
dc.identifier.scopus2-s2.0-105018856793
dc.identifier.startpage839
dc.identifier.urihttps://doi.org/10.1016/j.fertnstert.2025.08.011
dc.identifier.urihttps://hdl.handle.net/20.500.14288/31480
dc.identifier.volume124
dc.keywordsART
dc.keywordsclinical tests
dc.keywordsembryo prognostics
dc.keywordsPGT-a
dc.keywordsvalidation study
dc.language.isoeng
dc.publisherElsevier Inc.
dc.relation.affiliationKoç University
dc.relation.collectionKoç University Institutional Repository
dc.relation.ispartofFertility and Sterility
dc.relation.openaccessYes
dc.rightsCC BY-NC-ND (Attribution-NonCommercial-NoDerivs)
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/
dc.titleClinical validation of embryo prognostic tests; determining predictive value: phase 2
dc.typeReview
dspace.entity.typePublication

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