What is the Following Step to Improve Fertility in Infertile PCOS Patients Ovulating Under Clomiphene Citrate or Metformin? A Randomized Controlled Clinical Study.
Infertile PCOS patients who ovulated under CC or metformin without pregnancy achievement
will be enrolled and treated with three trials of COS plus IUI. All patients will be
randomly allocated into two different groups (groups A and B). In group A, COS will be
obtained using the same ovulatory agent (CC or metformin) employed in the previous ovulatory
cycles, whereas in group B using gonadotropins in a low-dose step-up regimen.
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 and the will be analyzed also
categorizing the patients according to ovulatory agent used for COS (CC or metformin).
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