[Translation] Phase II/III clinical trial of recombinant human follicle stimulating hormone-CTP fusion protein injection in assisted reproductive technology (ART) patients
II期试验
主要目的:以获卵数为指标,评价重组人卵泡刺激素-CTP融合蛋白注射液在进行ART患者中的初步疗效;
次要目的:评价重组人卵泡刺激素-CTP融合蛋白注射液在进行ART患者中的安全性、疗效、免疫原性、群体药代动力学特征。
III期试验
主要目的:以获卵数为指标,评价重组人卵泡刺激素-CTP融合蛋白注射液在进行ART患者中的疗效;
次要目的:评价重组人卵泡刺激素-CTP融合蛋白注射液在进行ART患者中的安全性、疗效、免疫原性。
[Translation] Phase II trial
Main purpose: To evaluate the preliminary efficacy of recombinant human follicle-stimulating hormone-CTP fusion protein injection in ART patients with the number of oocytes retrieved as an index;
Secondary objective: To evaluate the safety, efficacy, immunogenicity and population pharmacokinetic characteristics of recombinant human follicle stimulating hormone-CTP fusion protein injection in ART patients.
Phase III trial
Main purpose: To evaluate the efficacy of recombinant human follicle-stimulating hormone-CTP fusion protein injection in ART patients with the number of oocytes retrieved as an index;
Secondary objective: To evaluate the safety, efficacy and immunogenicity of recombinant human follicle stimulating hormone-CTP fusion protein injection in patients undergoing ART.