Identify Effective Doses of SHR7280 Tablets in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)

Summary

This study is a multicentre, open-label phase II dose-finding clinical trial that will recruit approximately 120 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI). We set up three SHR7280 tablets dose groups of 300 mg BID, 200 mg BID, and 200 mg QD with 40 subjects in each group, besides, a group of 400mg bid is set as an alternative.

Timeline

Start

2022-03-06

Primary completion

2023-08-03

Completion

2023-08-03

Publications

• Chi H, Song Y, Jin L, Song X, Wang X, Ma Q, Cao Y, Liang X, Tan J, Guan Y, Diao F, Li Y, Li Z, Sun Y, Shu C, Chen H, Shen K, Qiao J. SHR7280, an oral gonadotropin-releasing hormone antagonist, for the prevention of premature luteinizing hormone surge in controlled ovarian hyperstimulation: a dose-finding, phase 2 trial. Hum Reprod. 2025 Jul 1;40(7):1357-1365. doi: 10.1093/humrep/deaf082.

Drugs

Indications