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Phase IV Study to Evaluate the Efficacy and Safety of Fang Le Shu Compared to Guo Na Fen for Controlled Ovarian Stimulation in Infertile Women Undergoing in Vitro Fertilization-embryo Transfer (IVF-ET).
Sponsor: LG Chem
Summary
The aim of this randomized, open-label, active-controlled, parallel-group, multicenter, phase IV study is to assess the efficacy and safety of Fang Le Shu versus Guo Na Fen used for controlled ovarian stimulation in infertile women undergoing In Vitro Fertilization-Embryo Transfer.
Official title: A Phase IV, Prospective, Randomized, Open-label, Active-controlled, Parallel-group, Multicenter Study to Evaluate Efficacy and Safety of Fang Le Shu (Recombinant FSH) Versus Guo Na Fen Used for Controlled Ovarian Stimulation in Infertile Women Undergoing In Vitro Fertilization-Embryo Transfer.
Key Details
Gender
FEMALE
Age Range
20 Years - 39 Years
Study Type
INTERVENTIONAL
Enrollment
248
Start Date
2025-02-15
Completion Date
2026-06-30
Last Updated
2025-04-10
Healthy Volunteers
No
Conditions
Interventions
Fang Le Shu (Follitrope)
rFSH 150 IU, 225 IU, 300 IU per syringe
Guo Na Fen (Gonal-F)
rFSH 450 IU per pen
Locations (1)
The first affiliated hospital of Zhengzhou University
Zhengzhou, China