Working... Menu
Trial record 39 of 566 for:    "Polycystic Ovary Syndrome"

Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01157312
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : July 19, 2010
Information provided by:
Mansoura University

Brief Summary:
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 or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: clomiphene citrate +highly purified uFSH Drug: clomiphene citrate Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
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
Study Start Date : August 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. clinical pregnancy rate per cycle

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01157312

Layout table for location information
Mansoura University Hospitals,OB/GYN department
Mansoura, Dakahlia Governorate, Egypt
Sponsors and Collaborators
Mansoura University
Layout table for investigator information
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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
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
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: July 19, 2010
Last Verified: July 2010

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

Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
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