He Aihua, Zou Yangyun, Wan Cheng, Zhao Jing, Zhang Qiong, Yao Zhongyuan, Tian Fen, Wu Hong, Huang Xi, Fu Jing, Hu Chunxu, Sun Yue, Xiao Lan, Yang Tianli, Hou Zhaojuan, Dong Xin, Lu Sijia, Li Yanping
Department of Reproductive Medicine, Xiangya Hospital, Central South University, 87 Xiangya Road, Changsha, 410000, Hunan, China.
Clinical Research Center for Women's Reproductive Health in Hunan Province, Changsha, 410000, Hunan, China.
J Transl Med. 2021 Apr 28;19(1):176. doi: 10.1186/s12967-021-02837-y.
Window of implantation (WOI) displacement is one of the endometrial origins of embryo implantation failure, especially repeated implantation failure (RIF). An accurate prediction tool for endometrial receptivity (ER) is extraordinarily needed to precisely guide successful embryo implantation. We aimed to establish an RNA-Seq-based endometrial receptivity test (rsERT) tool using transcriptomic biomarkers and to evaluate the benefit of personalized embryo transfer (pET) guided by this tool in patients with RIF.
This was a two-phase strategy comprising tool establishment with retrospective data and benefit evaluation with a prospective, nonrandomized controlled trial. In the first phase, rsERT was established by sequencing and analyzing the RNA of endometrial tissues from 50 IVF patients with normal WOI timing. In the second phase, 142 patients with RIF were recruited and grouped by patient self-selection (experimental group, n = 56; control group, n = 86). pET guided by rsERT was performed in the experimental group and conventional ET in the control group.
The rsERT, comprising 175 biomarker genes, showed an average accuracy of 98.4% by using tenfold cross-validation. The intrauterine pregnancy rate (IPR) of the experimental group (50.0%) was significantly improved compared to that (23.7%) of the control group (RR, 2.107; 95% CI 1.159 to 3.830; P = 0.017) when transferring day-3 embryos. Although not significantly different, the IPR of the experimental group (63.6%) was still 20 percentage points higher than that (40.7%) of the control group (RR, 1.562; 95% CI 0.898 to 2.718; P = 0.111) when transferring blastocysts.
The rsERT was developed to accurately predict the WOI period and significantly improve the pregnancy outcomes of patients with RIF, indicating the clinical potential of rsERT-guided pET. Trial registration Chinese Clinical Trial Registry: ChiCTR-DDD-17013375. Registered 14 November 2017, http://www.chictr.org.cn/index.aspx.
着床窗（WOI）移位是胚胎着床失败，尤其是反复着床失败（RIF）的子宫内膜起源之一。迫切需要一种准确的子宫内膜容受性（ER）预测工具来精确指导胚胎成功着床。我们旨在建立一种基于RNA测序的子宫内膜容受性检测（rsERT）工具，使用转录组学生物标志物，并评估该工具指导下的个性化胚胎移植（pET）对RIF患者的益处。
这是一个两阶段策略，包括利用回顾性数据建立工具和通过前瞻性、非随机对照试验进行益处评估。在第一阶段，通过对50例WOI时间正常的体外受精患者的子宫内膜组织RNA进行测序和分析，建立了rsERT。在第二阶段，招募了142例RIF患者，通过患者自我选择进行分组（实验组，n = 56；对照组，n = 86）。实验组进行rsERT指导下的pET，对照组进行传统胚胎移植（ET）。
rsERT包含175个生物标志物基因，通过十折交叉验证显示平均准确率为98.4%。移植第3天胚胎时，实验组的宫内妊娠率（IPR）（50.0%）与对照组（23.7%）相比有显著提高（RR，2.107；95%CI 1.159至3.830；P = 0.017）。移植囊胚时，尽管差异不显著，但实验组的IPR（63.6%）仍比对照组（40.7%）高20个百分点（RR，1.562；95%CI 0.898至2.718；P = 0.111）。
开发rsERT是为了准确预测WOI期，并显著改善RIF患者的妊娠结局，表明rsERT指导下的pET具有临床应用潜力。试验注册中国临床试验注册中心：ChiCTR-DDD-17013375。于2017年11月14日注册，http://www.chictr.org.cn/index.aspx。
Zotero 插件
