NCT06921395

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).

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.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: LG Chem · Industry
• Sex: Female
• Age: 20 Years – 39 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Female Infertility

Interventions

Type	Name	Description
DRUG	Fang Le Shu (Follitrope)	rFSH 150 IU, 225 IU, 300 IU per syringe
DRUG	Guo Na Fen (Gonal-F)	rFSH 450 IU per pen

Timeline

• Start date: 2025-02-15
• Primary completion: 2025-09-30
• Completion: 2026-06-30
• First posted: 2025-04-10
• Last updated: 2025-04-10

Locations

1 site across 1 country: China