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Key metrics and processes for validating embryo diagnostics
Fertility and Sterility ( IF 6.7 ) Pub Date : 2020-07-01 , DOI: 10.1016/j.fertnstert.2020.04.053
Chaim Jalas 1 , Emre Seli 2 , Richard T Scott 2
Affiliation  

Embryo diagnostics are somewhat controversial in clinical assisted reproduction technology (ART) practice and remain an active area of investigation. Application of embryo diagnostics holds great potential to raise the standard of clinical care by eliminating futile transfers, allowing highly effective single-embryo transfer, and reducing the probability of clinical loss and ongoing abnormal gestations. These advantages are accompanied by risks, principally the chance that a reproductively competent embryo will be mislabeled and discarded. This would lower the ultimate probability that one or more of the embryos might implant and lead to delivery of a healthy infant. Rigorous validation should be required for embryo diagnostics. Metrics for validation can be divided into three simple areas: analytical validation, determination of clinical predictive values for normal and abnormal test results, and a randomized clinical trial to demonstrate that the selection advantage gained through the diagnostic improves clinical outcomes.

中文翻译:

验证胚胎诊断的关键指标和流程

胚胎诊断在临床辅助生殖技术 (ART) 实践中有些争议,并且仍然是一个活跃的研究领域。胚胎诊断的应用通过消除无用的移植、允许高效的单胚胎移植以及降低临床丢失和持续异常妊娠的可能性,具有提高临床护理标准的巨大潜力。这些优势伴随着风险,主要是有生殖能力的胚胎被贴错标签和丢弃的可能性。这将降低一个或多个胚胎可能植入并导致分娩健康婴儿的最终概率。胚胎诊断需要严格的验证。验证指标可以分为三个简单的领域:分析验证、
更新日期:2020-07-01
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