NCT01337531

Recombinant Versus Highly Purified FSH in Polycystic Ovary Syndrome (PCOS)

Recombinant FSH Versus Highly Purified FSH in PCOS Patients Undergoing Control Ovarian Stimulation and IVF: a Prospective Randomized Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Genesis Center for Fertility & Human Pre-Implantation Genetics · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Gonal-F, Fostimon	dosage form
DRUG	Gonal-F, Fostimon	injection, daily, 10-15 days

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2011-04-19
• Last updated: 2011-04-19

Locations

1 site across 1 country: Cyprus