基因重组人卵泡刺激素用于非低反应人群卵泡期长效促排卵方案的疗效分析

Efficacy analysis of recombinant human follicle stimulating hormone for long-term treatment of follicular phase in non-low response population

目的比较2种基因重组人卵泡刺激素(rFSH)制剂用于卵泡期长效促排卵方案的非低反应人群的疗效及安全性。方法回顾性纳入首次行卵泡期长效促排卵方案体外受精/胞质内单精子显微注射技术(IVF/ICSI)助孕治疗的非卵巢低反应不孕患者,均行控制性卵巢刺激(COS)卵泡期长效促排卵方案治疗,根据使用r FSH不同分为国产rFSH组(267个周期)和进口rFSH组(240个周期)。比较2组患者在超促排卵过程中的卵巢反应、用药情况、卵子受精及胚胎情况、新鲜胚胎移植及胚胎解冻移植后的妊娠率及活产率。结果超促排卵过程中,国产rFSH组HCG注射日雌二醇(E2)水平低于进口rFSH组(P<0.05),2组Gn总量、Gn使用天数、减数分裂中Ⅱ期(MⅡ)卵数、D3优质胚胎数、获得优质囊胚数等差异均无统计学意义(P>0.05)。主要疗效指标中,国产rFSH组及进口rFSH组的平均获卵数、新鲜胚胎移植周期临床妊娠率、冻融移植周期临床妊娠率等差异均无统计学意义(P>0.05),且2组患者的一次COS累积活产率比较差异均无统计学意义(P>0.05)。结论非低反应患者在卵泡期长效促排卵方案中使用国产rFSH或进口rFSH可获得同等安全的促排卵疗效和妊娠结局。

Objective To compare the efficacy and safety of domestic and imported recombinant human follicle stimulating hormone(rFSH)preparation for ovulation induction in non-low-response population with long-acting program in follicular phase.Methods Non-ovarian infertility patients with low response were retrospectively enrolled in our center for the first time to receive long-acting follicular phase IVF/ICSI assisted fertility treatment,all of whom received a COS longacting follicular phase therapy,and were divided into the domestic rFSH group(n=267)and the imported rFSH group(n=240)according to different use of rFSH.Ovarian response,medication,egg fertilization and embryo,fresh embryo transfer and embryo thawing transfer were compared between the two groups.Results During the process of superovulation,the level of E2 on HCG day was lower in the domestic rFSH group than that in the imported rFSH group(P<0.05).There were no significant differences in total Gn,days of Gn use,the number of MⅡeggs,the number of D3 excellent embryos and number of high-quality blastocysts between the two groups(P>0.05).In the primary efficacy indicators,there were no significant differences in the average number of egg retrieved,cumulative live birth rate of one COS number of fresh embryos,the clinical pregnancy rate in the transplantation cycle,and the clinical pregnancy rate in the freeze-thaw transplantation cycle between the two groups(P>0.05).Conclusion Compared with imported rFSH in the follicular phase,domestic rFSH can achieve the same safe efficacy and clinical outcome in non-low response patients.