A phase Ⅲ follow-up study of recombinant human follicle-stimulating hormone (Follitrope ?) over 6.5 years
10.3760/cma.j.cn101441-20240712-00253
- VernacularTitle:重组人促卵泡激素（芳乐舒 ?）6.5年的三期随访研究
- Author:
Zhiqin BU
1
;
Linli HU
;
Songying ZHANG
;
Jieqiang LYU
;
Song QUAN
;
Yuanhua HUANG
;
Weiping QIAN
;
Yingpu SUN
Author Information
1. 郑州大学第一附属医院生殖医学中心，郑州 450052
- Publication Type:Journal Article
- Keywords:
Controlled ovarian hyperstimulation;
Cumulative live birth rate;
Recombinant human follicle-stimulating hormone;
Advanced maternal age
- From:
Chinese Journal of Reproduction and Contraception
2024;44(12):1258-1264
- CountryChina
- Language:Chinese
-
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.
