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

April 18, 2011 updated by: Genesis Center for Fertility & Human Pre-Implantation Genetics

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Limassol, Cyprus, 3025
        • Genesis Centre for Fertility and Human Pre-implantation Genetics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • PCOS
  • Primary infertility
  • No other fertility manifestation

Exclusion Criteria:

  • Non PCOS
  • Secondary infertility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ovarian Response
Time Frame: 0-15 days post gonadotropin administration
0-15 days post gonadotropin administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Pregnancy rate
Time Frame: 12-15 days post embryo replacement
12-15 days post embryo replacement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genesis Center for Fertility & Human Pre-Implantation Genetics

Investigators

  • Principal Investigator: Savvas N Koundouros, PhD, Genesis Center for Fertility and Human Pre-implantation Genetics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

November 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

April 14, 2011

First Submitted That Met QC Criteria

April 18, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Estimate)

April 19, 2011

Last Update Submitted That Met QC Criteria

April 18, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rFSH.- HP-FSH.PCOS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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