Efficacy and safety of recombinant human granulocyte colony-stimulating factor in patients with unexplained recurrent pregnancy loss: a protocol for a multicenter, randomized, double-blind, controlled trial.

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Trials Pub Date : 2025-07-14 DOI:10.1186/s13063-025-08951-2
Fangxiang Mu, Zhuhua Cai, Lirong Du, Xianghui Zeng, Qi Zhou, Yaolong Chen, Fang Wang
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引用次数: 0

Abstract

Background: Unexplained recurrent pregnancy loss (uRPL), defined as the loss of two or more pregnancies without an identified cause, affects approximately 1-2% of women trying to conceive. Emerging evidence suggests that an imbalance in maternal-fetal immunological tolerance may play a key role in its pathogenesis. Granulocyte colony-stimulating factor (G-CSF), a glycosylated polypeptide chain cell growth factor, has shown promise in improving pregnancy outcomes in uRPL, although findings from previous clinical trials are inconsistent. High-quality, adequately powered studies are urgently needed to determine its clinical utility. This study aims to evaluate the efficacy and safety of G-CSF in Chinese women with uRPL, providing a more theoretical basis for clinical practice.

Methods: A randomized, double-blind, placebo-controlled, multicenter clinical trial will enroll 528 eligible participants, assigned to test group (n = 264, G-CSF 150 μg, subcutaneously every other day) and control group (n = 264, placebo), starting after confirmation of early pregnancy and ending at 10 weeks + 0 days of gestation. All participants will also receive dydrogesterone and aspirin as supportive care. The primary endpoint is fetal survival to 24 weeks, and secondary endpoints are early pregnancy loss, clinically confirmed pregnancy, ongoing pregnancy, fetal survival to 28 weeks, ectopic pregnancy, preterm birth, stillbirth, and pregnancy complications (preeclampsia, gestational diabetes mellitus, HELLP syndrome, placental abruption). The trial will also explore subgroup effects based on research centers (4 centers), age, number of pregnancy losses, and body mass index.

Discussion: This trial aims to provide high-quality evidence on the efficacy and safety of G-CSF in the treatment of uRPL, particularly in the Chinese population where existing data are limited. The findings may support evidence-based recommendations and inform treatment decisions in a population where therapeutic options remain limited and controversial.

Trial registration: ChiCTR2300077436. Prospectively registered on 2023-11-08.

重组人粒细胞集落刺激因子在不明原因复发性妊娠丢失患者中的疗效和安全性:一项多中心、随机、双盲、对照试验方案
背景:不明原因复发性妊娠丢失(uRPL),定义为两次或两次以上无明确原因的妊娠丢失,影响约1-2%的试图怀孕的妇女。新的证据表明,母体-胎儿免疫耐受的不平衡可能在其发病机制中起关键作用。粒细胞集落刺激因子(G-CSF)是一种糖基化多肽链细胞生长因子,已显示出改善uRPL妊娠结局的希望,尽管先前的临床试验结果不一致。迫切需要高质量、充分有力的研究来确定其临床应用。本研究旨在评价G-CSF治疗中国女性uRPL的疗效和安全性,为临床实践提供更多的理论依据。方法:采用随机、双盲、安慰剂对照、多中心临床试验,纳入528例符合条件的受试者,分为试验组(n = 264, G-CSF 150 μg,每隔一天皮下注射一次)和对照组(n = 264,安慰剂),从确认早孕开始至妊娠10周+ 0天结束。所有参与者还将接受地屈孕酮和阿司匹林作为支持治疗。主要终点是胎儿存活至24周,次要终点是早期妊娠丢失、临床证实妊娠、持续妊娠、胎儿存活至28周、异位妊娠、早产、死胎和妊娠并发症(先兆子痫、妊娠糖尿病、HELLP综合征、胎盘早剥)。该试验还将探索基于研究中心(4个中心)、年龄、流产次数和体重指数的亚组效应。讨论:本试验旨在为G-CSF治疗uRPL的有效性和安全性提供高质量的证据,特别是在现有数据有限的中国人群中。研究结果可能支持基于证据的建议,并为治疗选择仍然有限和有争议的人群提供治疗决策。试验注册:ChiCTR2300077436。预计在2023-11-08登记。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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