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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
History of Changes
  Purpose

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


Condition Intervention Phase
Polycystic Ovary Syndrome
 Drug: Gonal-F, Fostimon
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genesis Center for Fertility & Human Pre-Implantation Genetics:

Primary Outcome Measures:
  • Ovarian Response [ Time Frame: 0-15 days post gonadotropin administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy rate [ Time Frame: 12-15 days post embryo replacement ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • PCOS
  • Primary infertility
  • No other fertility manifestation

Exclusion Criteria:

  • Non PCOS
  • Secondary infertility
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Savvas Koundouros, Responsible party is an organization
ClinicalTrials.gov Identifier: NCT01337531     History of Changes
Other Study ID Numbers: rFSH.- HP-FSH.PCOS
Study First Received: April 14, 2011
Last Updated: April 18, 2011
Health Authority: Greece: Ethics Committee

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:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
 Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013