Comparison of Three Different Strategies for Treating Infertility in Anovulatory Women With Polycystic Ovary Syndrome: a Multicentre Randomized Controlled Clinical Trial
All patients eligible will undergo baseline assessment consisting of antropometric,
hormonal, and ultrasonographic assessments. Successively, patients enrolled will be
allocated in three different strategies (strategy A, B, and C).
A total of 184 infertile PCOS patients per arm will be enrolled and treated with three
different integrated strategies: clomiphene followed by clomiphene plus metformin followed
by gonadotropins (strategy A); metformin followed by metformin plus clomiphene followed by
gonadotropins(strategy B); and metformin plus clomiphene followed by gonadotropins(strategy
In all patients, the same regimen will be used to administered clomiphene, metformin, and
gonadotropins.Both clomiphene and metformin will be administered at incremental doses in
each case.Gonadotropins will be administrated to obtain a controlled ovarian stimulation
using highly purified urinary FSH in a low-dose step-up protocol.
During the study, the clinical and reproductive outcomes, and adverse experiences will be
evaluated in each woman.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Multiple pregnancy rate
Stefano Palomba, MD
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Italy: The Italian Medicines Agency