Comparison of recombinant human FSH biosimilar QL1012 with Gonal-f® for ovarian stimulation: a phase-three trial

卵巢过度刺激综合征 妇科 医学 不利影响 临床终点 随机对照试验 内科学 怀孕 生物 体外受精 遗传学
作者
Linli Hu,Jieqiang Lv,Qianhong Ma,Xiujuan Chen,Xiaohong Wang,Xiaoyan Liang,Xu Dingfei,Yanping Li,Yuanhua Huang,Lina Hu,Xiaohui Deng,Wei Jing,Feng Zhou,Songying Zhang,Jie Wang,Fang Ma,Yingpu Sun
出处
期刊:Reproductive Biomedicine Online [Elsevier BV]
卷期号:46 (3): 511-518 被引量:3
标识
DOI:10.1016/j.rbmo.2022.10.006
摘要

Are QL1012 and Gonal-f® equivalent in women undergoing ovarian stimulation for assisted reproductive technology (ART)?This multicentre, randomized, assessor-blinded, phase-three trial was conducted at 13 centres in China. Eligible patients were infertile women; age 20-39 years; body mass index 18-30 kg/m2; regular menstrual cycles; and indication for ART. After successful pituitary downregulation, patients were randomly assigned (1:1) to receive QL1012 or Gonal-f®, stratified by age (initial dose of 75-150 IU for women younger than 30 years, 150-225 IU for women aged 30-34 years and 225-300 IU for women aged ≥35 years, subcutaneously, once daily). The primary end point was the number of oocytes retrieved.Between October 2018, and June 2019, 341 patients were included in the per-protocol set. The mean numbers of oocytes retrieved were 14.7 ± 7.0 in the QL1012 group (n = 169) and 13.4 ± 6.1 in the Gonal-f® group (n = 172). Adjusted by analysis of covariance model, the least-squares mean difference was 1.3 oocytes (95% CI -0.1 to 2.7; P = 0.0650), within the pre-defined equivalence margins of ±3.0. Similar results were observed in the full analysis set. Additionally, no statistical differences were found in secondary end points except oestradiol concentration (median 3948.0 pg/ml versus 3545.3 pg/ml; P = 0.0015). Ovarian hyperstimulation syndrome (12.4% versus 13.1 %) and other adverse events were similar between the two groups.Therapeutic equivalence and similar safety profiles were demonstrated between QL1012 and Gonal-f® in women undergoing ovarian stimulation for ART.
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