[Translation] A multicenter, randomized, assessor-blind, positive parallel controlled phase III clinical trial of recombinant human follicle-stimulating hormone injection (LZ-B-01) and GONAL-F® in controlled ovarian hyperstimulation for assisted reproductive technology
主要目的:评价重组人促卵泡激素注射液(LZ-B-01)与果纳芬®用于辅助生殖技术(ART)控制性超促排卵治疗在获取卵母细胞数方面的疗效相似性,并进行等效性对比。
次要目的:1) 评价LZ-B-01与果纳芬®用于 ART 控制性超促排卵治疗在卵泡发育及内分泌特征的差异;2) 评价LZ-B-01与果纳芬®用于 ART 控制性超促排卵治疗在血清人绒毛膜促性腺激素/β-人绒毛膜促性腺激素(hCG/β-hCG)阳性率、临床妊娠率、持续妊娠率等疗效指标的差异;3) 评价 LZ-B-01与果纳芬®用于ART控制性超促排卵治疗的安全性差异;4) 评价 LZ-B-01与果纳芬®用于ART控制性超促排卵治疗的免疫原性差异;5) 评价 LZ-B-01用于ART控制性超促排卵治疗的药代动力学(PK)特征。
[Translation] Main purpose: To evaluate the similarity of the efficacy of recombinant human follicle-stimulating hormone injection (LZ-B-01) and GONAL-F® in obtaining oocytes in controlled superovulation therapy for assisted reproductive technology (ART), and to compare their equivalence.
Secondary objectives: 1) To evaluate the differences in follicular development and endocrine characteristics between LZ-B-01 and GONAL-F® for ART controlled ovarian hyperstimulation therapy; 2) To evaluate the differences in efficacy indicators such as serum human chorionic gonadotropin/β-human chorionic gonadotropin (hCG/β-hCG) positive rate, clinical pregnancy rate, and ongoing pregnancy rate between LZ-B-01 and GONAL-F® for ART controlled ovarian hyperstimulation therapy; 3) To evaluate the safety differences between LZ-B-01 and GONAL-F® for ART controlled ovarian hyperstimulation therapy; 4) To evaluate the differences in immunogenicity between LZ-B-01 and GONAL-F® for ART controlled ovarian hyperstimulation therapy; 5) To evaluate the pharmacokinetic (PK) characteristics of LZ-B-01 for ART controlled ovarian hyperstimulation therapy.