Recombinant Versus Highly Purified FSH in Polycystic Ovary Syndrome (PCOS)
Phase 2
- Conditions
- Polycystic Ovary Syndrome
- Interventions
- Drug: Gonal-F, Fostimon
- Registration Number
- NCT01337531
- Lead Sponsor
- Genesis Center for Fertility & Human Pre-Implantation Genetics
- Brief Summary
Control ovarian stimulation responses, pregnancy and miscarriage rates are indifferent when either recombinant or highly purified follicle stimulating hormone (FSH) is used.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 200
Inclusion Criteria
- PCOS
- Primary infertility
- No other fertility manifestation
Exclusion Criteria
- Non PCOS
- Secondary infertility
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gonadotropins Gonal-F, Fostimon recombinant versus highly purified gonadotropin gonadotropin Gonal-F, Fostimon recombinant or highly purified gonadotropin
- Primary Outcome Measures
Name Time Method Ovarian Response 0-15 days post gonadotropin administration
- Secondary Outcome Measures
Name Time Method Pregnancy rate 12-15 days post embryo replacement
Trial Locations
- Locations (1)
Genesis Centre for Fertility and Human Pre-implantation Genetics
🇨🇾Limassol, Cyprus
Genesis Centre for Fertility and Human Pre-implantation Genetics🇨🇾Limassol, Cyprus