Treatment of Anovulatory Infertility in PCOS Patients

This study has been completed.
Sponsor:
Information provided by:
University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00471523
First received: May 8, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound between them should be initially administered. The aim of the study will be to compare in a clinical setting the efficacy of CC and metformin as first-line approaches for treating anovulation in infertile PCOS patients.


Condition Intervention Phase
Infertility
Polycystic Ovary Syndrome
Anovulation
Drug: Clomiphene citrate
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: 10 months ]

Secondary Outcome Measures:
  • Ovulation rate [ Time Frame: 6 months ]
  • Abortion rate [ Time Frame: 10 months ]
  • Time to first pregnancy [ Time Frame: 10 months ]
  • Adverse events [ Time Frame: 10 months ]
  • N. pregnancies/n. ovulatory cycles [ Time Frame: 10 months ]

Enrollment: 80
Study Start Date: May 2006
Study Completion Date: March 2007
Detailed Description:

Eighty infertile anovulatory patients with PCOS will be allocated in two body mass index (BMI)- and age-matched groups (experimental and control groups).

Forty patients will receive the experimental treatment consisting of six months of 1700 mg/day metformin administration (experimental group), whereas other forty patients will receive CC administered using a traditional incremental-doses protocol (control group). In both groups, patients who will ovulate under treatment will continue the therapy for a total of six months.

During the study, the clinical and reproductive outcomes, and the adverse experience will be evaluated in each patient.

  Eligibility

Ages Eligible for Study:   18 Years to 41 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anovulatory infertility related to polycystic ovary syndrome

Exclusion Criteria:

  • Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
  • Hypothyroidism, hyperprolactinemia, Cushing’s syndrome, and non-classical congenital adrenal hyperplasia
  • Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
  • Organic pelvic diseases
  • Previous pelvic surgery
  • Suspected peritoneal factor infertility
  • Tubal or male factor infertility or sub-fertility
  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: NCT00471523

Locations
Italy
"Pugliese Hospital"
Catanzaro, CZ, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
Principal Investigator: Stefano Palomba, MD Department of Obstetrics & Gynecology, University “Magna Graecia” of Catanzaro
Principal Investigator: Achille Tolino, MD Department of Obstetrics & Gynecology, University “Federico II” of Naples
Principal Investigator: Francesco Orio, MD Department of Endocrinology, University “Federico II” of Naples
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00471523     History of Changes
Other Study ID Numbers: 02-2006
Study First Received: May 8, 2007
Last Updated: May 8, 2007
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University Magna Graecia:
Anovulation
Clomiphene citrate
Infertility
Metformin
PCOS
Treatment

Additional relevant MeSH terms:
Anovulation
Infertility
Polycystic Ovary Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Genital Diseases, Male
Ovarian Cysts
Cysts
Neoplasms
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Metformin
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

ClinicalTrials.gov processed this record on August 01, 2014