drugset / Trial / NCT06571214
Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment
RandomizedParallel-groupOpen-labelTreatment
Summary
This will be an exploratory, prospective, randomized, open-label and controlled trial to evaluate the potential benefit of r-hFSH:r-hLH 2:1 co-treatment starting from COS D1 versus r-hFSH alone in patients aged 35 to 40 under ovarian stimulation treatment. After signing informed consent form (ICF), all eligible participants will be randomly assigned in a 1:1 ratio to either treatment or control group, and GnRH antagonist protocol will be used in both treatment and control groups.
Timeline
- Start
- 2024-09-01
- Primary completion
- 2026-12-30
- Completion
- 2027-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gonal-f | Protein / enzyme biologic | 150 iu | Subcutaneous |
| Subject | Gonal-f | Protein / enzyme biologic | 450 iu | Subcutaneous |
| Subject | Luveris | Protein / enzyme biologic | — | — |