三种预充式重组卵泡刺激素在体外受精/卵胞浆内单精子注射助孕人群中的疗效分析OA
Efficacy analysis of three types of prefilled recombinant follicle-stimulating hormone in IVF/ICSI treatment
目的 比较进口重组卵泡刺激素(rFSH)-α、进口 rFSH-β与国产rFSH-α三种预充式rFSH注射液在体外受精/卵胞浆内单精子注射-胚胎移植(IVF/ICSI-ET)助孕周期中的临床疗效,评估国产预充式rFSH-α的临床应用价值.方法 回顾性分析2024年12月至2025年9月于安徽医科大学第一附属医院生殖医学中心首次接受IVF/ICSI-ET助孕、采用拮抗剂方案促排卵的1 099个周期的临床资料,根据使用的促排卵药物不同分为3组:进口 rFSH-α组(A组,n=306)、进口 rFSH-β组(B组,n=479)和国产rFSH-α组(C组,n=314).比较3组患者的基础资料、促排卵用药情况、促排卵结局、胚胎发育情况以及新鲜囊胚移植周期的临床妊娠率.结果 3组患者的年龄、体质量指数(BMI)、基础性激素水平等基础资料比较均无显著性差异(P>0.05).B组的促性腺激素(Gn)启动剂量和总剂量均显著低于A组与C组(P<0.05),而A组和C组间比较无显著性差异(P>0.05).3组患者的获卵数、MⅡ卵数、双原核(2PN)受精率、可移植囊胚数、优质囊胚率及中重度卵巢过度刺激综合征(OHSS)发生率比较均无显著性差异(P>0.05).3组间鲜胚移植周期的临床妊娠率比较亦无显著性差异(P>0.05).结论 在控制性卵巢刺激IVF/ICSI助孕周期中,国产预充式rFSH-α注射液在促排卵效率、胚胎实验室关键指标及鲜胚移植周期临床妊娠率方面,与两种成熟的进口预充式rFSH制剂疗效相当.国产预充式rFSH-α注射液为临床提供了安全、有效且可及性更高的新选择.
Objectives:To compare the clinical efficacy of three prefilled recombinant follicle-stimulating hormone(rFSH)preparations(imported rFSH-α,imported rFSH-β and domestic rFSH-α)in IVF/ICSI-ET cycles,and to evaluate the clinical application value of domestic prefilled rFSH-α. Methods:A retrospective analysis was performed on clinical data of 1 099 first IVF/ICSI-ET cycles with GnRH antagonist protocol for controlled ovarian stimulation from December 2024 to September 2025 in the Reproductive Medicine Center of The First Affiliated Hospital of Anhui Medical University.All cycles were divided into three groups based on the rFSH used:imported rFSH-α group(GroupA,n=306),imported rFSH-β group(Group B,n=479),and domestic rFSH-α group(Group C,n=314).Baseline characteristics,controlled ovarian stimulation parameters,embryonic development indicators and clinical pregnancy rate of fresh blastocyst transfer cycles were compared among the three groups. Results:There were no significant differences in the baseline characteristics including age,body mass index(BMI)and basal hormone levels among the three groups(P>0.05).The initial dose and total dose of gonadotropin(Gn)were significantly lower in Group B than in Group A and Group C(P<0.05),while no significant differences were found between Group A and Group C(P>0.05).There were no significant differences among the three groups in the number of oocytes retrieved,number of M Ⅱ oocytes,2-pronuclear(2PN)fertilization rate,number of transferable blastocysts,high-quality blastocyst rate,and incidence rate of moderate-to-severe ovarian hyperstimulation syndrome(OHSS)(P>0.05).The clinical pregnancy rate in fresh blastocyst transfer cycles showed no significant difference among the three groups(P>0.05). Conclusions:In controlled ovarian stimulation for IVF/ICSI,the domestic prefilled rFSH-α injection demonstrates comparable efficacy to the two imported prefilled rFSH preparations in terms of ovarian response,key embryological indicators,and clinical pregnancy rate in fresh embryo transfer cycles.Domestic prefilled rFSH-α could be a safe,effective,and more accessible alternative for clinical practice.
胡平;韩丹;汪诗羽;李关健;曹云霞
安徽医科大学第一附属医院妇产科生殖医学中心,合肥 230022||国家卫生健康委配子及生殖道异常研究重点实验室,合肥 230032||出生人口健康教育部重点实验室,合肥 230032安徽医科大学第一附属医院妇产科生殖医学中心,合肥 230022||国家卫生健康委配子及生殖道异常研究重点实验室,合肥 230032||出生人口健康教育部重点实验室,合肥 230032安徽医科大学第一附属医院妇产科生殖医学中心,合肥 230022||国家卫生健康委配子及生殖道异常研究重点实验室,合肥 230032||出生人口健康教育部重点实验室,合肥 230032安徽医科大学第一附属医院妇产科生殖医学中心,合肥 230022||国家卫生健康委配子及生殖道异常研究重点实验室,合肥 230032||出生人口健康教育部重点实验室,合肥 230032安徽医科大学第一附属医院妇产科生殖医学中心,合肥 230022||国家卫生健康委配子及生殖道异常研究重点实验室,合肥 230032||出生人口健康教育部重点实验室,合肥 230032
医药卫生
重组卵泡刺激素预充注射笔控制性卵巢刺激体外受精/卵胞浆内单精子注射-胚胎移植
Recombinant follicle-stimulating hormonePrefilled penControlled ovarian stimulationIVF/ICSI-ET
《生殖医学杂志》 2026 (8)
965-970,6
安徽省临床医学研究转化专项项目(202204295107020009)安徽省教育厅科研项目-优秀科研创新团队(2022AH010072)
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