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Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT01157312
First received: July 6, 2010
Last updated: July 16, 2010
Last verified: July 2010
History of Changes

July 6, 2010
July 16, 2010
August 2008
April 2010   (final data collection date for primary outcome measure)
clinical pregnancy rate per cycle [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01157312 on ClinicalTrials.gov Archive Site
endometrial thickness at the time of hCG administration [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome
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).

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Polycystic Ovary Syndrome
  • Drug: clomiphene citrate +highly purified uFSH
  • Drug: clomiphene citrate
  • 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
    Intervention: 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.
    Intervention: Drug: clomiphene citrate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Congenital adrenal hyperplasia
  • Cushing syndrome
  • Androgen secreting tumors
Female
20 Years to 39 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01157312
MU-290s, FMH-212-G
Yes
Dr. Hatem Abu Hashim, Associate Prof. of OB/GYN, Mansoura Faculty of Medicine, Mansoura University.
Mansoura University
Not Provided
Principal Investigator: Hatem Abu Hashim, MD MRCOG Mansoura University Hospitals
Study Director: Mohamed F Bazeed, MD Mansoura University Hospitals
Study Chair: Ibrahim Abd Elaal, MD Mansoura University Hospitals
Mansoura University
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP