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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01337531
Recruitment Status : Unknown
Verified April 2011 by Genesis Center for Fertility & Human Pre-Implantation Genetics.
Recruitment status was:  Enrolling by invitation
First Posted : April 19, 2011
Last Update Posted : April 19, 2011
Sponsor:
Information provided by:
Genesis Center for Fertility & Human Pre-Implantation Genetics

Tracking Information
First Submitted Date  ICMJE April 14, 2011
First Posted Date  ICMJE April 19, 2011
Last Update Posted Date April 19, 2011
Study Start Date  ICMJE May 2011
Estimated Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2011)
Ovarian Response [ Time Frame: 0-15 days post gonadotropin administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2011)
Pregnancy rate [ Time Frame: 12-15 days post embryo replacement ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recombinant Versus Highly Purified FSH in Polycystic Ovary Syndrome (PCOS)
Official Title  ICMJE Recombinant FSH Versus Highly Purified FSH in PCOS Patients Undergoing Control Ovarian Stimulation and IVF: a Prospective Randomized Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 18, 2011)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • PCOS
  • Primary infertility
  • No other fertility manifestation

Exclusion Criteria:

  • Non PCOS
  • Secondary infertility
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cyprus
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01337531
Other Study ID Numbers  ICMJE rFSH.- HP-FSH.PCOS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Savvas Koundouros, Responsible party is an organization
Study Sponsor  ICMJE Genesis Center for Fertility & Human Pre-Implantation Genetics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Savvas N Koundouros, PhD Genesis Center for Fertility and Human Pre-implantation Genetics
PRS Account Genesis Center for Fertility & Human Pre-Implantation Genetics
Verification Date April 2011

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