drugset / Trial / 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).
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-02-15
- Primary completion
- 2025-09-30
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fang Le Shu | Protein / enzyme biologic | 150 iu | — |
| Subject | Fang Le Shu | Protein / enzyme biologic | 225 iu | — |
| Subject | Fang Le Shu | Protein / enzyme biologic | 300 iu | — |
| Comparator | Guo Na Fen | Protein / enzyme biologic | 450 iu | — |