Controlled Ovarian Stimulation Followed by Timed Intercourse or Intrauterine Insemination in Infertile PCOS Patients

Polycystic Ovary Syndrome Clinical Trial

Official title: Timed Intercourse Versus Intrauterine Insemination in Infertile Patients Undergoing Gonadotropin Ovarian Stimulation

Status Suspended

Clinical Trial Summary

At the present the first options to induce ovulation in polycystic ovary syndrome with anovulatory infertility are clomiphene citrate (CC) and metformin. Notwithstanding the effectiveness of CC and metformin alone or in a sequential or combined regimen, a percentage of patients ranging from 5% to 30% remain anovulatory. For these patients, the use of gonadotropins for controlled ovarian stimulation (COS) is indicated.

Moreover, to date it isn't clear if COS should be followed by timed intercourse (TI) or intrauterine insemination (IUI).

The aim of the present study will be to compare TI and IUI in infertile PCOS patients undergoing COS in terms of cost-benefit.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

• NCT number: NCT00502281
• Study type: Interventional
• Source: University Magna Graecia
• Status: Suspended
• Phase: Phase 4
• Start date: January 2007