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.
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.
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.