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RECRUITING
NCT06921395
PHASE4

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

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

The first affiliated hospital of Zhengzhou University

Zhengzhou, China