RecruitingPhase 4NCT06921395

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.


Sponsor

LG Chem

Enrollment

248 participants

Start Date

Feb 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Fang Le Shu (Follitrope) and a drug called Guo Na Fen (Gonal-F) for people with female infertility. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 20 Years to 39 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFang Le Shu (Follitrope)

rFSH 150 IU, 225 IU, 300 IU per syringe

DRUGGuo Na Fen (Gonal-F)

rFSH 450 IU per pen


Locations(1)

The first affiliated hospital of Zhengzhou University

Zhengzhou, China

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NCT06921395


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