Effects of the Zishen Yutai Pill on live births compared with placebo among infertile women with frozen-thawed embryo transfer cycle: A multicentre double-blind randomized controlled trial.

Autor: Chen X; Center for Reproductive Medicine, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, China., Shi Y; Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China; Shandong Provincial Clinical Research Center for Reproductive Health, Jinan, China., Li H; Center for Reproduction and Genetics, Suzhou Municipal Hospital, Suzhou, China., Gong F; Reproductive Center, Reproductive & Genetic Hospital of CITIC-XIANGYA, Changsha, China., Yao C; Reproductive Center, Liuzhou Maternal and Child Care Service Centre, Liuzhou, China., Bai H; Reproductive Center, Northwest Women and Children's Hospital, Xi'an, China., Fan Y; Department of Reproduction, The Second Hospital of Hebei Medical University, Shijiazhuang, China., Shi D; Reproductive Center, Yinchuan Maternal and Child Health Hospital, Yinchuan, China., Qu Q; Reproductive Medical Department, Yantai Yuhuangding Hospital Affiliated to Qingdao University, Yantai, China., Diao F; Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University, Nanjing, China; Clinical Center of Reproductive Medicine, Jiangsu Province Hospital, Nanjing, China., Zhu Y; Department of Reproductive Endocrinology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China., Yang D; Center for Reproductive Medicine, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, China. Electronic address: yangdz@mail.sysu.edu.cn.
Jazyk: angličtina
Zdroj: Phytomedicine : international journal of phytotherapy and phytopharmacology [Phytomedicine] 2024 Dec; Vol. 135, pp. 156072. Date of Electronic Publication: 2024 Sep 18.
DOI: 10.1016/j.phymed.2024.156072
Abstrakt: Background: Zishen Yutai Pill exhibited clinical benefit to infertile women undergoing fresh embryo transfer cycles, improving their pregnancy outcomes. However, as the endometrial environment in frozen embryo transfer (FET) is different from fresh cycles, the effects of ZYP on fresh embryo transfer could not be generalized to FET.
Objective: We aimed to explore the effects of ZYP on live birth rate in women's FET cycles.
Methods: This multicentre, double-blind, placebo-controlled, randomized study was conducted at 11 reproductive medical centres in China. Women were recruited and randomly assigned to ZYP or placebo intervention (5 g once, 3 times per day) around the time of FET. The live birth rate was set as the primary outcome. Secondary outcomes included implantation rate, biochemical pregnancy rate, clinical pregnancy rate, pregnancy loss rates. Data was analyzed based on the intention-to-treat principle, with per protocol analysis as sensitivity analysis.
Results: Between December 2017 and April 2019, 934 women were screened, of whom 880 met all eligibility criteria and were allocated to ZYP (n=441) or placebo (n=439). In ITT analysis, the live birth rates were 38.32% (169/441) in ZYP group and 32.57% (143/439) (absolute difference 5.75%, 95%CI [-0.57%, 12.00%], OR 1.29, 95%CI [0.98, 1.70], P=0.08). The intervention of ZYP did not result in significantly differences in all secondary outcomes compared with placebo (all P>0.05). Similar trends were observed in PP analysis. In post hoc analysis, ZYP resulted in higher rates of live birth than placebo among women in specific subgroups, i.e., with miscarriage history (39.23% vs. 26.45%, P=0.01) or advanced maternal age (33.93% vs. 21.85%, P=0.04).
Conclusion: In infertile women undergoing FET cycle, intervention with ZYP led to a trend of live birth rate increment compared with placebo, but without statistical significance. However, women with miscarriage history and advanced age could experience possible benefits from ZYP intervention.
Registration: ChiCTR-INR-17010809 (http://www.chictr.org.cn).
Competing Interests: Declaration of competing interest This study was supported by the Guangdong Provincial Bureau of Traditional Chinese Medicine (Grant No. 20174002), Guangzhou International Science and Technology Cooperation Project (Grant No. 201807010044). Guangzhou Baiyunshan Zhongyi Pharmaceutical Co. Ltd. donated the study drugs, including Zishen Yutai Pill and the placebo for this research, but had no role in the data acquisition, statistical analysis and writing of this article. The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024. Published by Elsevier GmbH.)
Databáze: MEDLINE
Externí odkaz: