Comparison of recombinant human FSH biosimilar QL1012 with Gonal-f® for ovarian stimulation: a phase-three trial |
| |
| Institution: | 1. Reproductive Medicine Center, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China;2. Reproductive Medicine Center, The Second Affiliated Wenzhou Medical University, Wenzhou, China;3. Reproductive Medicine Center, West China Second University Hospital of Sichuan University, Chengdu, China;4. Reproductive Medicine Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China;5. Reproductive Medicine Center, Tangdu Hospital, Xi''an, China;6. Reproductive Medicine Center, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China;7. Reproductive Medicine Center, Jiangxi Maternal and Child Health Hospital, Nanchang, China;8. Reproductive Medicine Center, Xiangya Hospital of Central South University, Changsha, China;9. Reproductive Medicine Center, The First Affiliated Hospital of Hainan Medical College, Haikou, China;10. Reproductive Medicine Center, The Second Affiliated Hospital of Chongqing Medical University Chongqing, China;11. Reproductive Medicine Center, Qilu Hospital of Shandong University, Jinan, China;12. Reproductive Medicine Center, Liuzhou Worker''s Hospital, Liuzhou, China;13. Assisted Reproduction Unit, Department of Obstetrics and Gynecology, Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, Hangzhou, China;14. Clinical Research Center, Qilu Pharmaceutical Co., Ltd., Jinan, China;1. Reproductive Medical Center, The First Affiliated Hospital of Guangxi Medical University, Nanning, China;2. The Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, China;1. Division of Gynaecological Endocrinology and Reproductive Medicine, University Women''s Hospital, Inselspital, Bern, Switzerland;2. Clinical Trials Unit Bern, University of Bern, Switzerland |
| |
| Abstract: | Research questionAre QL1012 and Gonal-f® equivalent in women undergoing ovarian stimulation for assisted reproductive technology (ART)?DesignThis 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.ResultsBetween 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.ConclusionsTherapeutic equivalence and similar safety profiles were demonstrated between QL1012 and Gonal-f® in women undergoing ovarian stimulation for ART. |
| |
| Keywords: | |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
