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

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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

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

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Gonal-F, Fostimon Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Recombinant FSH Versus Highly Purified FSH in PCOS Patients Undergoing Control Ovarian Stimulation and IVF: a Prospective Randomized Study
Study Start Date : May 2011
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: gonadotropin
recombinant or highly purified gonadotropin
Drug: Gonal-F, Fostimon
dosage form
Other Name: Recombinant Gonadotropin, Highly purified Gonadotropin
Active Comparator: Gonadotropins
recombinant versus highly purified gonadotropin
Drug: Gonal-F, Fostimon
injection, daily, 10-15 days
Other Names:
  • Gonal-F
  • Fostimon



Primary Outcome Measures :
  1. Ovarian Response [ Time Frame: 0-15 days post gonadotropin administration ]

Secondary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 12-15 days post embryo replacement ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • PCOS
  • Primary infertility
  • No other fertility manifestation

Exclusion Criteria:

  • Non PCOS
  • Secondary infertility

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337531


Locations
Cyprus
Genesis Centre for Fertility and Human Pre-implantation Genetics
Limassol, Cyprus, 3025
Sponsors and Collaborators
Genesis Center for Fertility & Human Pre-Implantation Genetics
Investigators
Principal Investigator: Savvas N Koundouros, PhD Genesis Center for Fertility and Human Pre-implantation Genetics

Responsible Party: Savvas Koundouros, Responsible party is an organization
ClinicalTrials.gov Identifier: NCT01337531     History of Changes
Other Study ID Numbers: rFSH.- HP-FSH.PCOS
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: April 19, 2011
Last Verified: April 2011

Keywords provided by Genesis Center for Fertility & Human Pre-Implantation Genetics:
Ovarian Response in PCOS
pregnancy rate in PCOS
miscarriage rate in PCOS

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases