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Brief Title: Treatment of Anovulatory Infertility in PCOS Patients
Official Title: Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome
Study ID: NCT00471523
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.
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.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
"Pugliese Hospital", Catanzaro, CZ, Italy
Name: Stefano Palomba, MD
Affiliation: Department of Obstetrics & Gynecology, University "Magna Graecia" of Catanzaro
Role: PRINCIPAL_INVESTIGATOR
Name: Achille Tolino, MD
Affiliation: Department of Obstetrics & Gynecology, University "Federico II" of Naples
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Orio, MD
Affiliation: Department of Endocrinology, University "Federico II" of Naples
Role: PRINCIPAL_INVESTIGATOR