Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome

July 16, 2010 updated by: Mansoura University

Minimal Stimulation or Clomiphene Citrate as First Line Therapy in Women With Polycystic Ovary Syndrome

The purpose of this study is to compare and determine the the efficacy of minimal stimulation and clomiphene citrate(CC) as the first-line treatment in infertile women with Polycystic Ovary Syndrome(PCOS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients received 100 mg CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) for 5 days starting from day 3 of spontaneous or induced menstruation. In group A (minimal stimulation), 2 vials of highly purified uFSH , 150 IU (Fostimon; IBSA, Lugano, Switzerland, 75 IU/vial) were given IM on cycle day 9. A total of 3 cycles was offered to each group.

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

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

  • Egypt
    • Dakahlia Governorate
      • Mansoura, Dakahlia Governorate, Egypt
        • Mansoura University Hospitals,OB/GYN department

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 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • PCOS
  • No other infertility factors
  • No previous use of ovarian stimulation drugs

Exclusion Criteria:

  • Congenital adrenal hyperplasia
  • Cushing syndrome
  • Androgen secreting tumors

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: minimal stimulation protocol
5 days of CC (100mg/day) from day 3 followed by 150 IU of highly purified uFSH on cycle day 9 for three treatment cycles
Drug: clomiphene citrate +highly purified uFSH
Active Comparator: clomiphene citrate(CC)
5 days of CC (100mg/day) from cycle day 3 for three treatment cycles.
Drug: clomiphene citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
clinical pregnancy rate per cycle

Secondary Outcome Measures

Outcome Measure
endometrial thickness at the time of hCG administration

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Study Director: Mohamed F Bazeed, MD, Mansoura University Hospital
  • Study Chair: Ibrahim Abd Elaal, MD, Mansoura University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

July 6, 2010

First Submitted That Met QC Criteria

July 6, 2010

First Posted (Estimate)

July 7, 2010

Study Record Updates

Last Update Posted (Estimate)

July 19, 2010

Last Update Submitted That Met QC Criteria

July 16, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU-290s
  • FMH-212-G

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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