Timed Intercourse Versus Intrauterine Insemination in Infertile Patients Undergoing Gonadotropin Ovarian Stimulation
Infertile PCOS patients who remain anovulatory after CC or metformin treatment will be
enrolled. All patients will receive gonadotropins in low-dose step-up protocol for COS, and
randomized to receive three trials of TI (group A) or IUI (group B).
All patients eligible will undergo baseline assessment consisting of anthropometric,
hormonal, and ultrasonographic evaluations.
In all patients the COS will be obtained using highly purified urinary FSH in a low-dose
step-up protocol, and both TI and IUI will be performed after 35 hours from ovulation
induction with human chorionic gonadotropin.
During the study, the clinical and reproductive outcomes, 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: 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