Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Stefano Palomba, MD
Department of Obstetrics & Gynecology, University “Magna Graecia” of Catanzaro
Italy: The Italian Medicines Agency