Key metrics and processes for validating embryo diagnostics
Key metrics and processes for validating embryo diagnostics
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DOI：
10.1016/j.fertnstert.2020.04.053
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发表时间：
2020-07-01
影响因子：
6.7
通讯作者：
Scott, Richard T., Jr.
中科院分区：
文献类型：
--
作者：
Jalas, Chaim;Seli, Emre;Scott, Richard T., Jr.
胚胎诊断在临床辅助生殖技术（ART）实践中有些争议，仍然是一个活跃的研究领域。胚胎诊断的应用具有巨大的潜力，通过消除无效的移植，允许高效的单胚胎移植，降低临床丢失和持续异常妊娠的概率，提高临床护理标准。这些优势伴随着风险，主要是有生殖能力的胚胎被错误标记和丢弃的机会。这将降低一个或多个胚胎植入并导致健康婴儿出生的最终概率。胚胎诊断需要严格的验证。验证的方法可以分为三个简单的领域：分析验证，确定正常和异常检测结果的临床预测值，以及随机临床试验，以证明通过诊断获得的选择优势可以改善临床结果。（Fertil Steril（R）2020;114：16 - 23。(C)美国生殖医学会（American Society for Reproductive Medicine）
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 trans- fers, 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 dis- carded. 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 demon- strate that the selection advantage gained through the diagnostic improves clinical outcomes. (Fertil Steril (R) 2020;114:16 -23. (C) 2020 by American Society for Reproductive Medicine.)