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Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome

This study has been completed.
Information provided by:
Mansoura University Identifier:
First received: July 6, 2010
Last updated: July 16, 2010
Last verified: July 2010
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).

Condition Intervention
Polycystic Ovary Syndrome Drug: clomiphene citrate +highly purified uFSH Drug: clomiphene citrate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minimal Stimulation or Clomiphene Citrate as First Line Therapy in Women With Polycystic Ovary Syndrome

Resource links provided by NLM:

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • clinical pregnancy rate per cycle

Secondary Outcome Measures:
  • endometrial thickness at the time of hCG administration

Enrollment: 113
Study Start Date: August 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Congenital adrenal hyperplasia
  • Cushing syndrome
  • Androgen secreting tumors
  Contacts and Locations
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Please refer to this study by its identifier: NCT01157312

Mansoura University Hospitals,OB/GYN department
Mansoura, Dakahlia Governorate, Egypt
Sponsors and Collaborators
Mansoura University
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Hatem Abu Hashim, Associate Prof. of OB/GYN, Mansoura Faculty of Medicine, Mansoura University. Identifier: NCT01157312     History of Changes
Other Study ID Numbers: MU-290s
Study First Received: July 6, 2010
Last Updated: July 16, 2010

Keywords provided by Mansoura University:
Polycystic ovary syndrome
clomiphene citrate
minimal stimulation
infertility treatment

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators processed this record on August 17, 2017