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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Genesis Center for Fertility & Human Pre-Implantation Genetics
ClinicalTrials.gov Identifier:
NCT01337531
First received: April 14, 2011
Last updated: April 18, 2011
Last verified: April 2011

April 14, 2011
April 18, 2011
May 2011
November 2011   (final data collection date for primary outcome measure)
Ovarian Response [ Time Frame: 0-15 days post gonadotropin administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01337531 on ClinicalTrials.gov Archive Site
Pregnancy rate [ Time Frame: 12-15 days post embryo replacement ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Polycystic Ovary Syndrome
  • Drug: Gonal-F, Fostimon
    dosage form
    Other Name: Recombinant Gonadotropin, Highly purified Gonadotropin
  • Drug: Gonal-F, Fostimon
    injection, daily, 10-15 days
    Other Names:
    • Gonal-F
    • Fostimon
  • Experimental: gonadotropin
    recombinant or highly purified gonadotropin
    Intervention: Drug: Gonal-F, Fostimon
  • Active Comparator: Gonadotropins
    recombinant versus highly purified gonadotropin
    Intervention: Drug: Gonal-F, Fostimon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
200
December 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • PCOS
  • Primary infertility
  • No other fertility manifestation

Exclusion Criteria:

  • Non PCOS
  • Secondary infertility
Female
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Cyprus
 
NCT01337531
rFSH.- HP-FSH.PCOS
Yes
Savvas Koundouros, Responsible party is an organization
Genesis Center for Fertility & Human Pre-Implantation Genetics
Not Provided
Principal Investigator: Savvas N Koundouros, PhD Genesis Center for Fertility and Human Pre-implantation Genetics
Genesis Center for Fertility & Human Pre-Implantation Genetics
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP