Efficacy of Long- Versus Short-term Metformin Protocol in Infertile Anovulatory PCOS Patients
Infertile PCOS patients having three ovulatory cycles under metformin, administered using
tailored protocol, will be enrolled and randomized in two groups (groups A and B). Patients
of group A will continue metformin administration for further three cycles followed by six
months of progestogens cyclically administered, whereas patients of group B will continue
metformin therapy for further nine cycles.
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. Cumulative pregnancy rate, our primary end-point, will be
calculated by the Kaplan-Maier method, and the differences between the two groups will be
assessed with the log-rank test. Cox proportional-hazards model will be used to calculate
the hazard ratio for new pregnancy in both groups.
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