ABSTRACT

For patients with recurrent implantation failure in IVF, histologic or transcriptomic testing of the endometrium during the mid-secretory phase is often considered. Histological dating of endometrial biopsies (Noyes criteria) can determine if endometrial morphology is consistent with the period of receptivity. Alternatively, endometrial tissue can be sent for a commercial Endometrial Receptivity Array (ERA) test which characterizes the gene expression of the endometrium using a panel of 238 genes that have been implicated in endometrial receptivity. This study aimed to compare the two tests to assess their concordance and to examine the ability of the ERA to successfully predict implantation and pregnancy in a subsequent personalized embryo transfer. A retrospective review was done of 97 patients with a history of implantation failure who underwent an ERA, 35 of whom had histologic dating on the same sample. ERA and histology were classified as ‘concordant’ when samples were receptive by both tests or non-receptive by both tests. The ERA result was then used to personalize the embryo transfer day, and pregnancy rates from the first subsequent frozen transfer cycle were analyzed. The results indicated that there is poor concordance between ERA and histological dating with only 40.0% agreement and a kappa (95%CI) = −0.18 (−0.50, 0.14). According to the ERA, 48.5% of biopsies were receptive, 47.4% were non-receptive and 2.01% were insufficient tissue for analysis. The clinical pregnancy rate in patients shown to be receptive by ERA was 26.7% and non-receptive was 22.5% following the subsequent personalized ET (p = 0.66). This study concludes that there is a high degree of discordance between histological dating of the endometrium and molecular analysis by ERA. There was no evidence of clinical benefit when embryo transfer was personalized according to ERA in patients with a history of implantation failure.

摘要

对于 IVF 中反复植入失败的患者，通常考虑在分泌中期对子宫内膜进行组织学或转录组学检测。子宫内膜活检的组织学年代（Noyes 标准）可以确定子宫内膜形态是否与容受期一致。或者，可以将子宫内膜组织送去进行商业子宫内膜容受性阵列 (ERA) 测试，该测试使用一组 238 个与子宫内膜容受性有关的基因来表征子宫内膜的基因表达。本研究旨在比较这两种测试以评估它们的一致性并检查 ERA 在随后的个性化胚胎移植中成功预测植入和怀孕的能力。对 97 名有植入失败病史并接受 ERA 的患者进行了回顾性研究，其中 35 名在同一样本上进行了组织学测年。当样品通过两种测试均可接受或两种测试均不可接受时，ERA 和组织学被归类为“一致”。然后将 ERA 结果用于个性化胚胎移植日，并分析第一个后续冷冻移植周期的妊娠率。结果表明 ERA 和组织学年代之间的一致性较差，一致性仅为 40.0%，kappa (95%CI) = -0.18 (-0.50, 0.14)。根据 ERA，48.5% 的活组织检查可接受，47.4% 不接受，2.01% 的组织不足以进行分析。ERA 显示接受的患者的临床妊娠率为 26.7%，未接受的患者为 22。5% 跟随随后的个性化 ET (p = 0.66)。该研究得出结论，子宫内膜的组织学年代测定与 ERA 的分子分析之间存在高度不一致。在有植入失败病史的患者中，根据 ERA 进行个性化胚胎移植没有临床益处的证据。