摘要
目的 对重组人促卵泡激素(芳乐舒®)三期临床研究进行随访,评估患者的累积妊娠率、累积活产率和新生儿结局指标.方法 对芳乐舒®中国三期临床研究(NCT03506243/CTR20150341,2015年5月15日至2016年6月27日)进行随访至2022年12月31日.本研究分为芳乐舒®组和果纳芬®组,按照年龄分为20～30岁、31～35岁和36～39岁三个亚组.对患者的累积妊娠率、累积活产率、移植胚胎数、每获胚活产数、每获卵活产数、鲜胚移植和冻胚移植的临床妊娠率、鲜胚移植和冻胚移植的活产率、新生儿表征(双胎妊娠率、体质量、性别、出生缺陷率)等指标进行评估和分析.结果 共446例患者纳入分析,其中芳乐舒®组336例,果纳芬®组110例,随访时间为6.5年.芳乐舒®组和果纳芬®组的累积妊娠率、累积活产率差异均无统计学意义(均P>0.05).各年龄亚组两组间累积妊娠率和累积活产率差异均无统计学意义(均P>0.05),36～39岁亚组中芳乐舒®组累积妊娠率[60.0%(12/20)]、累积活产率[55.0%(11/20)]相比于果纳芬®组[28.6%(2/7),14.3%(1/7)]有增高趋势,但差异均无统计学意义(均P>0.05).芳乐舒®组和果纳芬®组的双胎妊娠率、每获胚活产数、每获卵活产数、新生儿性别、新生儿体质量、出生缺陷率差异均无统计学意义(均P>0.05).结论 芳乐舒®在控制性超促排卵中的安全性、有效性与果纳芬®相似.相比于果纳芬®,芳乐舒®在高龄人群中的累积妊娠率和累积活产率有增高趋势,但差异无统计学意义.
Abstract
Objective To follow-up the previous phase Ⅲ clinical trial of recombinant human follicle-stimulating hormone(Follitrope®),and to evaluate the cumulative pregnancy rate,the cumulative live birth rate,and the neonatal outcomes of subjects.Methods The phase Ⅲ clinical study of Follitrope® in China(CTR20150341/CTR20150341,May 15,2015—June 27,2016)was followed up until December 31,2022.Patients were divided into Follitrope® group and Gonal-F® group.According to the age,patients were divided into three subgroups:20-30 years old subgroup,31-35 years old subgroup and 36-39 years old subgroup.Cumulative pregnancy rate,cumulative live birth rate,number of embryos transferred per cycle,live births per embryo transfer cycle,live births per oocyte retrieved,and neonatal characteristics were analyzed.Results A total of 446 patients were included in the analysis,of which 336(75.3％)were in the Follitrope® group and 110(24.7％)in the Gonal-F® group,with a follow-up period of 6.5 years.There were no statistically significant differences between the Follitrope® group and the Gonal-F® group in terms of cumulative pregnancy rate and cumulative live birth rate(all P>0.05).Similar cumulative pregnancy rates and cumulative live birth rates were observed between the two groups within each age subgroup(all P>0.05).In the 36-39 years old subgroup,the Follitrope® group showed a trend towards higher cumulative pregnancy rate[60.0％(12/20)]and cumulative live birth rate[55.0％(11/20)]compared with the Gonal-F® group[28.6％(2/7),14.3％(1/7)],however,none of the differences were statistically significant(all P>0.05).Twin pregnancy rates,live births per embryo,live birth per oocyte,newborn gender,birth weight,and birth defect rates were similar between the Follitrope® group and the Gonal-F® group without statistically significant differences(all P>0.05).Conclusion The safety and effectiveness of Follitrope® in controlled ovarian hyperstimulation are similar to those of Gonal-F®.Compared with Gonal-F®,there is a trend toward higher cumulative pregnancy rates and cumulative live birth rates in elderly patients with Follitrope®,although there is no statistical difference.
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