生殖医学杂志

目的对比和分析控制性促排卵中不同促性腺激素(Gn)使用4 d后血中FSH值的不同,及其对IVF/ICSI-ET助孕指标及结局的影响;并分析不同批次国产r-FSH在控制性卵巢刺激过程中的临床稳定性。方法回顾性分析2017年12月至2018年12月于我中心应用长方案行IVF/ICSI-ET助孕患者的临床资料,按照其应用Gn药物的不同分为3组:进口r-FSH组(n=330)、国产r-FSH组(n=95)、国产u-FSH组(n=63)。对比分析3组启动促排卵日FSH值、Gn使用4 d后血清FSH上升情况,以及其他实验室及临床结局指标。同时就不同批次的国产r-FSH的相关应用结局指标进行对比分析。结果三种药物组患者间年龄、不孕年限、体重指数、基础FSH(bFSH)值、AMH值、助孕次数、启动日FSH水平、Gn天数、平均获卵数、HCG日子宫内膜厚度、子宫内膜容受性评分、MⅡ卵率、可用胚胎数、移植胚胎数、临床妊娠率、OHSS发生率、早期流产率等均无统计学差异(P>0.05);三种药物组Gn应用4 d后血FSH上升水平,以国产u-FSH组上升最高,国产r-FSH组上升最低,u-FSH组与r-FSH组间有统计学差异(P<0.05),两种r-FSH组间无统计学差异(P>0.05);Gn总量以国产u-FSH组用量最大,进口r-FSH组用量最低,国产u-FSH组与进口r-FSH组间有统计学差异(P<0.05),而两种r-FSH组间无统计学差异(P>0.05)。国产r-FSH组3个不同批次间患者年龄、不孕年限、血AMH值、BMI、助孕次数、MⅡ卵率、可用胚胎数、移植胚胎个数、临床妊娠率、OHSS发生率、早期流产率等均无统计学差异(P>0.05)。结论三种不同FSH制剂有不同的吸收及入血浓度,但均可达到良好的助孕结局;国产r-FSH批间药效稳定,临床助孕过程及助孕结局良好。

Objective:To analyze the difference of serum FSH levels 4 days after using the three different gonadotropins(Gn) and the effects on the pregnancy-assisted indicators and outcomes of IVF/ICSI-ET,and explore the clinical stability of different batches of domestic recombinant FSH(r-FSH) during controlled ovarian stimulation.Methods:A retrospective analysis was made on IVF/ICSI-ET assisted pregnancies in our center from December 2017 to December 2018. The patients were divided into three groups according to their different Gn medications:imported r-FSH group(n=330),domestic r-FSH group(n=95) and domestic u-FSH group(n=63). The FSH level on the day of ovulation induction,the increase of serum FSH level 4 days after Gn administration,and the other laboratory and clinical outcome indicators were compared among the three groups. At the same time,the relevant application outcome indicators of different batches of domestic r-FSH were compared.Results:There were no significant differences in age,infertility duration,body mass index(BMI),basal serum FSH(bFSH) levels,AMH levels,number of assisted pregnancy,FSH levels,days of Gn used,average number of oocytes retrieved,endometrial thickness on HCG day,endometrial receptivity score,MⅡ oocyte rate,number of available embryos,number of transplanted embryos,clinical pregnancy rate,incidence of OHSS and early abortion rate,etc(P>0.05). Comparing the increase of serum FSH level 4 days after administrating the three different Gn,the domestic u-FSH was the highest,the domestic r-FSH was the lowest,and there was a significant difference between u-FSH and r-FSH(P<0.05). There was no significant difference between the two r-FSHs(P>0.05). The total amount of Gn used of the domestic u-FSH was the highest,the lowest in imported r-FSH,and there was a significant difference(P<0.05). There was no statistical difference between the two r-FSHs(P>0.05). There were no significant differences in age,infertility duration,serum AMH level,BMI,number of assisted pregnancy,MⅡ oocyte rate,number of available embryos,number of transplanted embryos,clinical pregnancy rate,incidence of OHSS,early abortion among three different batches of domestically produced r-FSH(P>0.05).Conclusions:Three different FSH preparations have different absorption and blood concentration,but all can achieve a good pregnancy outcome. The efficacy of the different batches of domestic r-FSH is stable,clinical pregnancy-promoting process and pro-pregnancy outcomes are good.