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).

NCT06921395 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2025-04-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • LG Chem

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-15
Primary Completion
2025-09-30
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06921395 on ClinicalTrials.gov