drugset / Trial / NCT06091436
To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference
Phase 3
Completed
176 enrolled
Changchun GeneScience Pharmaceutical Co., Ltd.
Sixth Affiliated Hospital, Sun Yat-sen University · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To investigate the efficacy and safety of a single injection of GenSci094 to induce multi-follicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of GenSci094 is non-inferior to daily treatment with recFSH in initiating multi-follicular growth.
Timeline
- Start
- 2023-03-24
- Primary completion
- 2023-12-25
- Completion
- 2024-01-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GenSci094 | Protein / enzyme biologic | 100 ug | Subcutaneous |
| Subject | GenSci094 | Protein / enzyme biologic | 150 ug | Subcutaneous |
| Comparator | Gonal-f | Protein / enzyme biologic | 75 iu | Subcutaneous |
| Comparator | Gonal-f | Protein / enzyme biologic | 150 iu | Subcutaneous |
| Comparator | Gonal-f | Protein / enzyme biologic | 225 iu | Subcutaneous |
| Comparator | Gonal-f | Protein / enzyme biologic | 300 iu | Subcutaneous |
| Background | Ganirelix | Protein / enzyme biologic | 0.25 mg | Subcutaneous |
| Background | Progesterone | Other / unclassified | 40 mg | Oral |
| Background | Progesterone | Other / unclassified | 400 mg | Oral |
| Background | hCG | Protein / enzyme biologic | 5000 iu | — |
| Background | hCG | Protein / enzyme biologic | 10000 iu | — |