The clinical efficiency of transcriptome-based endometrial receptivity assessment (Tb-ERA) in Chinese patients with recurrent implantation failure (RIF): A study protocol for a prospective randomized controlled trial

基于转录组的子宫内膜容受性评估(Tb-ERA)在中国复发性植入失败(RIF)患者中的临床疗效:一项前瞻性随机对照试验的研究方案

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作者:Wen-Bi Zhang, He Li, Xiang Lu, Jun-Ling Chen, Lu Li, Jiu-Cheng Chen, Han Wu, Xiao-Xi Sun

Background

Today, approximately 10% of participants in assisted reproductive technology (ART) are defined as having recurrent implantation failure (RIF). Recent studies show that endometrial receptivity array can improve pregnancy and implantation rates by nearly 20% in women with RIF. However, these studies are limited, with little published data in the Chinese population. Recently, we have established a transcriptome-based endometrial receptivity assessment (Tb-ERA) method of predicting the endometrial window of implantation (WOI) using transcriptome-profiling data of different phases of the menstrual cycle from healthy fertile Chinese women by RNA-Seq. It is meaningful to conduct a randomized controlled trial (RCT) to assess the clinical efficiency of Tb-ERA in Chinese patients with RIF.

Methods

In this RCT, a total of 200 RIF patients will be recruited and randomized into 2 groups. Patients in the Tb-ERA group will undergo a Tb-ERA test, after which embryo transfer time will be adjusted according to Tb-ERA

Trial registration

NCT04497558, registered August 4, 2020.

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