A phase Ⅲ follow-up study of recombinant human follicle-stimulating hormone(Follitrope?)over 6.5 years
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.
Controlled ovarian hyperstimulationCumulative live birth rateRecombinant human follicle-stimulating hormoneAdvanced maternal age