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NCT01337531 Clinical Trial

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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01337531
Other study ID # rFSH.- HP-FSH.PCOS
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received April 14, 2011
Last updated April 18, 2011
Start date May 2011
Est. completion date December 2011

Study information
Verified date April 2011
Source Genesis Center for Fertility & Human Pre-Implantation Genetics
Contact n/a
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Interventional

Clinical Trial Summary

Control ovarian stimulation responses, pregnancy and miscarriage rates are indifferent when either recombinant or highly purified follicle stimulating hormone (FSH) is used.

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 information / eligibility
Status Enrolling by invitation
Enrollment 200
Est. completion date December 2011
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- PCOS

- Primary infertility

- No other fertility manifestation

Exclusion Criteria:

- Non PCOS

- Secondary infertility

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Gonal-F, Fostimon
dosage form
• Gonal-F, Fostimon
injection, daily, 10-15 days

Locations
Country Name City State
Cyprus Genesis Centre for Fertility and Human Pre-implantation Genetics Limassol

Sponsors (1)
Lead Sponsor Collaborator
Genesis Center for Fertility & Human Pre-Implantation Genetics

Country where clinical trial is conducted

Cyprus, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ovarian Response 0-15 days post gonadotropin administration No
Secondary Pregnancy rate 12-15 days post embryo replacement No
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