Tailored Versus Non-tailored Metformin Protocol for Ovulation Induction in Infertile Anovulatory PCOS Patients. A Randomized Controlled Clinical Study
Infertile anovulatory PCOS eligible patients will be enrolled and randomly allocated to
receive tailored (tailored group) or non-tailored metformin treatment (non-tailored group).
Tailored metformin treatment will consist of incremental doses regimen starting from a
dosage of 850 mg daily (one tablet daily) with a weekly increase up to 2550 mg daily (three
tablets daily). The dosage of metformin will be reduced according to the appearance of
serous or affecting compliance drug-related side effects. Conversely, non-tailored metformin
treatment consisted of fixed doses regimen of 850 mg twice daily. For both groups, the
treatment will be of six months.
All patients eligible will undergo baseline assessment consisting of anthropometric,
hormonal, and ultrasonographic evaluations. During the study, the clinical and reproductive
outcomes, and the adverse experience will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less
will be considered significant. Continuous variables will be analyzed with the unpaired t
test and general linear model for repeated measures analysis with Bonferroni test for the
post-hoc analysis as required. For categorical variables, the Pearson chi-square and
Fisher's exact tests will be used.
Allocation: 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