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
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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