Recombinant FSH Versus Highly Purified FSH in PCOS Patients Undergoing Control Ovarian Stimulation and IVF: a Prospective Randomized Study
20 Years
40 Years
Female
Polycystic Ovary Syndrome
Trial Information
Recombinant FSH Versus Highly Purified FSH in PCOS Patients Undergoing Control Ovarian Stimulation and IVF: a Prospective Randomized Study
Patients will be randomized using sealed and numbered envelopes and will be assigned to
receive a similar ovarian stimulation regime incorporating either Gonal-F or highly purified
Fostimon as the hormonal analog. Ovarian response using either of the two compounds,
pregnancy rates and miscarriage rates will be compared to define possible statistical
significance.
Inclusion Criteria:
- PCOS
- Primary infertility
- No other fertility manifestation
Exclusion Criteria:
- Non PCOS
- Secondary infertility
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Ovarian Response
Outcome Time Frame:
0-15 days post gonadotropin administration
Safety Issue:
No
Principal Investigator
Savvas N Koundouros, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Genesis Center for Fertility and Human Pre-implantation Genetics
Authority:
Greece: Ethics Committee
Study ID:
rFSH.- HP-FSH.PCOS
NCT ID:
NCT01337531
Start Date:
May 2011
Completion Date:
December 2011
Related Keywords:
- Polycystic Ovary Syndrome
- Ovarian Response in PCOS
- pregnancy rate in PCOS
- miscarriage rate in PCOS
- Polycystic Ovary Syndrome
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