search
Back to results

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

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Phase 2
Locations
Cyprus
Study Type
Interventional
Intervention
Gonal-F, Fostimon
Gonal-F, Fostimon
Sponsored by
Genesis Center for Fertility & Human Pre-Implantation Genetics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Ovarian Response in PCOS, pregnancy rate in PCOS, miscarriage rate in PCOS

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • PCOS
  • Primary infertility
  • No other fertility manifestation

Exclusion Criteria:

  • Non PCOS
  • Secondary infertility

Sites / Locations

  • Genesis Centre for Fertility and Human Pre-implantation Genetics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

gonadotropin

Gonadotropins

Arm Description

recombinant or highly purified gonadotropin

recombinant versus highly purified gonadotropin

Outcomes

Primary Outcome Measures

Ovarian Response

Secondary Outcome Measures

Pregnancy rate

Full Information

First Posted
April 14, 2011
Last Updated
April 18, 2011
Sponsor
Genesis Center for Fertility & Human Pre-Implantation Genetics
search

1. Study Identification

Unique Protocol Identification Number
NCT01337531
Brief Title
Recombinant Versus Highly Purified FSH in Polycystic Ovary Syndrome (PCOS)
Official Title
Recombinant FSH Versus Highly Purified FSH in PCOS Patients Undergoing Control Ovarian Stimulation and IVF: a Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Genesis Center for Fertility & Human Pre-Implantation Genetics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Ovarian Response in PCOS, pregnancy rate in PCOS, miscarriage rate in PCOS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gonadotropin
Arm Type
Experimental
Arm Description
recombinant or highly purified gonadotropin
Arm Title
Gonadotropins
Arm Type
Active Comparator
Arm Description
recombinant versus highly purified gonadotropin
Intervention Type
Drug
Intervention Name(s)
Gonal-F, Fostimon
Other Intervention Name(s)
Recombinant Gonadotropin, Highly purified Gonadotropin
Intervention Description
dosage form
Intervention Type
Drug
Intervention Name(s)
Gonal-F, Fostimon
Other Intervention Name(s)
Gonal-F, Fostimon
Intervention Description
injection, daily, 10-15 days
Primary Outcome Measure Information:
Title
Ovarian Response
Time Frame
0-15 days post gonadotropin administration
Secondary Outcome Measure Information:
Title
Pregnancy rate
Time Frame
12-15 days post embryo replacement

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: PCOS Primary infertility No other fertility manifestation Exclusion Criteria: Non PCOS Secondary infertility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Savvas N Koundouros, PhD
Organizational Affiliation
Genesis Center for Fertility and Human Pre-implantation Genetics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genesis Centre for Fertility and Human Pre-implantation Genetics
City
Limassol
ZIP/Postal Code
3025
Country
Cyprus

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs