drugset / Trial / NCT02466204
Efficacy of Corifollitropin Alfa Versus Follitropin Beta in Aged IVF (In-vitro Fertilization) Patients
Phase 4
Completed
400 enrolled
Vietnam National University
Merck Sharp & Dohme LLC · collabMỹ Đức Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A prospective, randomized, controlled study to explore the efficacy and safety of using either corifollitropin alfa 150 mcg or daily recombinant follicle stimulation hormone (FSH) 300 international unit (IU) for the stimulation treatment of subjects undergoing controlled ovarian stimulation prior to IVF. The study is designed as a non-inferiority trial. The sample size for this trial of 400 subjects, in both groups, being treated for one IVF cycle is based upon the primary endpoint of the number of oocytes retrieved.
Timeline
- Start
- 2015-06-01
- Primary completion
- 2016-08-10
- Completion
- 2017-08-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Corifollitropin alfa | Protein / enzyme biologic | 150 ug | Subcutaneous |
| Comparator | Follitropin beta | Protein / enzyme biologic | 300 iu | Subcutaneous |