生殖医学杂志2025，Vol.34Issue(10)：1320-1327,8.DOI:10.3969/j.issn.1004-3845.2025.10.004
国产西曲瑞克在促性腺激素释放激素拮抗剂方案中的应用:一项前瞻性真实世界研究
Domestic cetrorelix for gonadotropin releasing hormone antagonist protocol:a prospective real-world study
王星祎 1范莉 2徐仰英 3欧建平 4夏婷婷 4张翠莲1
作者信息
- 1. 河南省人民医院,郑州 450003
- 2. 广州市妇女儿童医疗中心柳州医院,柳州 545616
- 3. 青岛大学附属妇女儿童医院,青岛 266034
- 4. 中山大学附属第三医院,广州 510635
- 折叠
摘要
Abstract
Objectives:To evaluate the efficacy and safety of a domestic cetrorelix acetate for injection in the antagonist protocol for in vitro fertilization(IVF)and intracytoplasmic sperm injection(ICSI)among infertile patients.
Methods:This multicenter,prospective,observational,single-arm study enrolled infertile patients with normal ovarian reserve function undergoing IVF-embryo transfer(ET)or ICSI.Following a controlled ovarian stimulation protocol that included a fixed addition of an antagonist,routine embryo culture and transfer were conducted,and pregnancy outcomes were followed up.The primary outcome was the clinical pregnancy rate,while secondary outcomes encompassed the early luteinizing hormone(LH)peak rate and the embryo implantation rate.Safety assessments included the severity and incidence of ovarian hyperstimulation syndrome(OHSS)and adverse events.
Results:A total of 201 subjects were enrolled in this study,among which 2 were excluded due to incorrect enrollment,resulting in a final case count of 199 included in the full analysis set(FAS).Among patients treated with JinsaijieⓇcetrorelix acetate for injection in the gonadotropin-releasing hormone(GnRH)antagonist protocol,the clinical pregnancy rate was 55.75％,the premature LH surge rate was 2.53％,the OHSS rate was 1.99％,and the drug-related adverse event rate was 3.48％.No serious adverse events or drug-related serious adverse events were observed.
Conclusions:JinsaijieⓇ cetrorelix acetate for injection demonstrates favorable efficacy and safety in controlled ovarian stimulation,offering a viable option for clinical practice.关键词
醋酸西曲瑞克/促性腺激素释放激素拮抗剂/临床效果/安全性Key words
Cetrorelix acetate/Gonadotropin-releasing hormone antagonist/Clinical efficacy/Safety分类
临床医学引用本文复制引用
王星祎,范莉,徐仰英,欧建平,夏婷婷,张翠莲..国产西曲瑞克在促性腺激素释放激素拮抗剂方案中的应用:一项前瞻性真实世界研究[J].生殖医学杂志,2025,34(10):1320-1327,8.
