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

Abstract

Clinical 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.