Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale University School of Medicine, New Haven, Connecticut 06520-8063, USA.
Curr Opin Obstet Gynecol. 2012 Jun;24(3):141-50. doi: 10.1097/GCO.0b013e328352cd17.
A multitude of novel embryo assessment strategies using genomics, transcriptomics, proteomics, and metabolomics approaches are being developed in order to improve upon the currently utilized embryo assessment methods based on morphology and cleavage rate. Although these novel technologies promise significant improvements in clinical outcome for women undergoing infertility treatment with in-vitro fertilization, their validation poses significant challenges. In this review, we discuss the appropriate steps to be taken in clinical validation of an embryo assessment test. We then provide a critical analysis of the studies evaluating embryo assessment strategies from a methodological perspective.
Validation of a novel embryo assessment test requires the determination of appropriate performance parameters (such as sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve), followed by clinical validation using appropriate study design. Finally, benefit from a test, alone or in combination with currently used methods, needs to be tested using a prospective randomized controlled trial study design. Few studies on existing or novel embryo assessment methods provide these parameters.
Validation of a test is a rigorous process that needs to be handled meticulously, using appropriate performance parameters determined by the inherent characteristics of the test and clinical studies with appropriate design.
为了改进目前基于形态和卵裂率的胚胎评估方法，正在开发大量使用基因组学、转录组学、蛋白质组学和代谢组学方法的新型胚胎评估策略。尽管这些新技术有望显著改善接受体外受精治疗的不孕女性的临床结局，但它们的验证仍面临重大挑战。在这篇综述中，我们讨论了在临床验证胚胎评估测试时应采取的适当步骤。然后，我们从方法学的角度对评估胚胎评估策略的研究进行了批判性分析。
新型胚胎评估测试的验证需要确定适当的性能参数（如敏感性、特异性、阳性预测值、阴性预测值和曲线下面积），然后使用适当的研究设计进行临床验证。最后，需要使用前瞻性随机对照试验设计来测试该测试单独或与当前使用的方法相结合的益处。很少有关于现有或新型胚胎评估方法的研究提供这些参数。
测试的验证是一个严格的过程，需要使用适当的设计，通过测试固有的特性和临床研究来精心处理，以确定适当的性能参数。
