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Prospective Randomized Clinical Trial to Test the Efficacy of a Biosimilar Recombinant Follicle Stimulating Hormone (FSH)vs. Urinary FSH in an Oocyte Donation Program (BEMDON)
Biosimilar drug marketing of recombinant FSH for the treatment of infertility is another step in simplifying fertility treatments, making them easier to manage and more accessible to patients. Taking in mind these arguments ,the study is proposed for determining equivalence in terms of biological effectiveness of an ovarian stimulation protocol with biosimilar recombinant FSH stimulation protocol vs. urinary FSH in oocyte donation program.
Details
| Lead sponsor | IVI Madrid |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 130 |
| Start date | 2015-10 |
| Completion | 2016-06 |
Conditions
- Infertility
Interventions
- Biosimilar recombinant FSH
- Urinary FSH
Primary outcomes
- Number of metaphase II oocytes — 1 day
Countries
Spain