Treatment of Anovulatory Infertility in PCOS Patients

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: NCT00471523
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : May 10, 2007
Information provided by:
University Magna Graecia

Brief Summary:
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 or disease Intervention/treatment Phase
Infertility Polycystic Ovary Syndrome Anovulation Drug: Clomiphene citrate Drug: Metformin Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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): NCT00471523

"Pugliese Hospital"
Catanzaro, CZ, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00471523     History of Changes
Other Study ID Numbers: 02-2006
First Posted: May 10, 2007    Key Record Dates
Last Update Posted: May 10, 2007
Last Verified: May 2007

Keywords provided by University Magna Graecia:
Clomiphene citrate

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Hypoglycemic Agents
Physiological Effects of Drugs
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists