两种重组人卵泡刺激素注射液在不同人群中的促排卵效果分析

Analysis of ovulation induction effects of two kinds of recombinant human follicle-stimulating hormone injections among different patients

目的探究具有不同糖修饰谱的两种重组人卵泡刺激素(rFSH)在不同人群中行控制性促排卵(COH)临床应用的有效性和安全性。方法回顾性分析2022年1—12月期间本中心的320个COH周期的临床资料,按照COH中使用的rFSH种类不同分为A组(芳乐舒,95个周期)和B组(Puregon,225个周期)。比较两组患者在起始剂量、刺激时间、HCG日激素水平和内膜厚度、获卵数、减数分裂Ⅱ期(MⅡ)卵率、受精率、卵裂率、有效胚胎率、卵母细胞利用率和胚胎利用率等方面的差异。结果在A、B两组患者的年龄[(34.9±4.9)岁vs.(33.3±4.5)岁,P=0.006]、体质量指数(BMI)[(22.5±3.2)kg/m^(2) vs.(21.6±2.6)kg/m^(2),P=0.027]存在一定差异的前提下,A组获卵数与B组相当[(11.2±7.0)vs.(12.9±7.3),P=0.059]。在拮抗剂方案COH周期,两组患者年龄相近(P>0.05),此时两组的获卵数[(13.7±7.1)vs.(14.8±7.6),P=0.340]及其他结局指标均无统计学差异(P>0.05)。将所有患者根据年龄分层分析,高龄(≥35岁)亚组中,A组患者受精率[(78.1±19.6)%vs.(69.1±25.8)%,P=0.039]、卵裂率[(98.9±3.2)%vs.(93.7±22.1)%,P=0.039]和卵母细胞利用率[(44.9±30.6)%vs.(34.1±23.5)%,P=0.037]显著高于B组;低龄(<35岁)亚组中,A、B两组患者各项结局指标均无统计学差异(P>0.05)。通过逐步多元回归分析,确定COH方案和年龄是获卵数的预测因素(P<0.001),最终回归模型可解释28.8%的反应变异性。结论芳乐舒与Puregon两种rFSH具有相似的获卵数和获胚结局,在高龄人群中芳乐舒诱导的卵母细胞质量可能较高。

Objective:To investigate the efficacy and safety of two kinds of recombinant human follicle-stimulating hormone(rFSH)with different glycan modification profiles for clinical use among different patients undergoing controlled ovulation hyperstimulation(COH).Methods:Clinical data from a total of 320 cycles of COH using Follitrope or Puregon between January 2022 and December 2022 at Reproductive Medicine Center of Zhongshan Hospital,Fudan University were retrospectively analyzed.According to the type of rFSH used in COH,patients were divided into group A(Follitrope,95 cycles)and group B(Puregon,225 cycles).The differences between the two groups were compared in terms of starting doses of rFSH,duration of treatment,levels of hormones and endometrial thickness on HCG day,number of oocytes retrieved,metaphaseⅡoocyte rate,the fertilization rate,the cleavage rate,effective embryo rate,oocyte utilization rate and embryo utilization rate.Results:The number of oocytes retrieved in group A was comparable to that of group B[(11.2±7.0)vs.(12.9±7.3),P=0.059],provided that there were some differences between the two groups in terms of age[(34.9±4.9)years old vs.(33.3±4.5)years old,P=0.006],BMI[(22.5±3.2)kg/m^(2) vs.(21.6±2.6)kg/m^(2),P=0.027].In the antagonist COH cycles,the age was similar between the two groups(P>0.05),and there was no statistical differences in the outcome indicators such as the number of oocytes retrieved[(13.7±7.1)vs.(14.8±7.6),P=0.340].All patients were further divided into older subgroups(≥35 years old)and younger subgroups(<35 years old).In the older subgroup,the fertilization rate[(78.1±19.6)%vs.(69.1±25.8)%,P=0.039],the cleavage rate[(98.9±3.2)%vs.(93.7±22.1)%,P=0.039],and oocyte utilization rate[(44.9±30.6)%vs.(34.1±23.5)%,P=0.037]of group A were significantly higher than those of group B.In the younger subgroup,there were no significant differences in various indicators(P>0.05)between group A and group B.The COH protocol and age were identified as predictors of the number of oocytes acquired by stepwise multiple regression analysis(P<0.001),explaining 28.8%of the response variability.Conclusions:Similar oocytes and embryo retrieval outcomes were found when compared Puregon to Follitrope,but the quality of oocytes induced by Follitrope would be higher in older patients.