The First Multiple Center Prospective Study of RhFSH CTP in Patients Undergoing Assisted Reproductive Technology in China

Overview

Journal Sci Rep

Date 2025 Jan 21

PMID 39837901

Authors

Longmei Wu

Huayan Yin

Lingfang Guan

Guanjian Li

Junqiang Zhang

Qunshan Shen

Xiaoqing Ni

Chao Wang

Tianjuan Wang

Hao Geng

Chuan Xu

Yunxia Cao

Xiaojin He

Bing Song

Affiliations

Soon will be listed here.

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 top-quality embryos, implantation rates, and pregnancy outcomes were similar between the two groups (P > 0.05). In the rhFSH-CTP group, no cases of severe OHSS were observed, which was a significant improvement compared to the 1.4% incidence in the rhFSH group. With regard to another safety endpoint, no patients tested positive for adenosine deaminase (ADA) in the rhFSH-CTP group. The results demonstrated that the product had a comparable safety profile to pregnancy outcomes and newborn information in the control group, indicating its suitability for use.

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