[Translation] A multicenter, randomized, double-blind, parallel-controlled phase III clinical trial evaluating the efficacy and safety of human follicle-stimulating hormone alpha (Hydrogen troponin α) injection (Shengnuova®) in participants aged ≥35 years undergoing assisted reproductive technology (ART).
主要目的:评价绒促卵泡激素α N01注射液在≥35岁进行ART的试验参与者中的疗效。
次要目的:评价绒促卵泡激素α N01注射液在≥35岁进行ART的试验参与者中的安全性、药效学(PD)特征、群体药代动力学(PopPK)特征、免疫原性。
[Translation] Primary objective: To evaluate the efficacy of human follicle-stimulating hormone (hFSH) α N01 injection in trial participants ≥35 years of age undergoing ART.
Secondary objective: To evaluate the safety, pharmacodynamic (PD) characteristics, population pharmacokinetic (PopPK) characteristics, and immunogenicity of hFSH α N01 injection in trial participants ≥35 years of age undergoing ART.