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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by Genesis Center for Fertility & Human Pre-Implantation Genetics.
Recruitment status was:  Enrolling by invitation
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
  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
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

Resource links provided by NLM:


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 ]

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

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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on August 17, 2017