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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • endometrial thickness at the time of hCG administration [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   20 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157312

Locations
Egypt
Mansoura University Hospitals,OB/GYN department
Mansoura, Dakahlia Governorate, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Hatem Abu Hashim, Associate Prof. of OB/GYN, Mansoura Faculty of Medicine, Mansoura University.
ClinicalTrials.gov Identifier: NCT01157312     History of Changes
Other Study ID Numbers: MU-290s, FMH-212-G
Study First Received: July 6, 2010
Last Updated: July 16, 2010
Health Authority: Egypt: Institutional Review Board

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

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on August 26, 2014