The first multiple center prospective study of rhFSH CTP in patients undergoing assisted reproductive technology in China.

ABSTRACT: We assessed the safety and efficacy of rhFSH-CTP, a novel long-acting FSH agent, in controlled ovarian hyperstimulation for patients undergoing ART. A multi-center, open-label, randomized, positive-control, non-inferiority clinical trial was conducted. The study consisted of a phase III randomized design, with a 1:1 ratio favoring the rhFSH-CTP group over the control group. Eligible patients in the rhFSH-CTP group received a single dose of rhFSH-CTP at 100-150 µg for the first 7d of stimulation following a gonadotropin-releasing hormone antagonist protocol. In total, 142 and 141 patients received rhFSH-CTP and rhFSH, respectively. At a confidence interval of 95%, the difference in the number of oocytes (1.13-4.22, 2.67) suggested that rhFSH-CTP was not inferior to rhFSH. Additionally, the

SUBMITTER: Wu L 

PROVIDER: S-EPMC11751185 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature