Clinical Trial

Identify Effective Doses of LY01021 in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)

Active, Not Recruiting Phase 2
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Record status
This record was last updated November 19, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a multicentre, open-label, dose-finding, phase 2 study that will recruit approximately 90 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI). Three LY01021 dose groups of 40 mg QD, 30 mg QD, and 20 mg QD will be included, with not exceed 45 subjects in each group to investigate the efficacy and safety.
Trial Details
NCT Number NCT07236476
Lead Sponsor Luye Pharma Group Ltd.
Conditions Assisted Reproduction
Enrollment 90 participants
Start Date 2024-10-09
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-19