Official Title: “Timed Intercourse Versus Intrauterine Insemination in Infertile Patients Undergoing Gonadotropin Ovarian Stimulation”

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.

Study Type: Interventional

Study Design: Treatment, Open Label, Active Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: highly purified urinary FSH
• Behavioral: timed intercourses, intrauterine insemination

Primary Measures

• Pregnancy rate

Secondary Measures

• Abortion rate
• Live-birth rate
• Adverse events
• OHSS
• Multiple pregnancy rate
• Costs

Inclusion Criteria:

• Polycystic ovary syndrome (using NIH criteria)
• Anovulatory infertility (using WHO criteria)

Exclusion Criteria:

• Age <18 or >35 years
• Severe obesity (BMI >35)
• Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
• Hypothyroidism, hyperprolactinemia, Cushing’s syndrome, and non-classical congenital adrenal hyperplasia
• Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, anti-obesity drugs, hormonal drugs
• Intention to start a diet or a specific program of physical activity
• Organic pelvic diseases
• Previous pelvic surgery
• Suspected peritoneal factor infertility
• Tubal or male factor infertility or sub-fertility

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Lead Sponsor: University Magna Graecia

Overall Clinical Trial Officials and Contacts

Stefano Palomba, MD Principal Investigator Department of Obstetrics & Gynecology, University “Magna Graecia” of Catanzaro  

Overall Contact: Stefano Palomba, MD +39-0961-883234 stefanopalomba@tin.it

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00502281

Study ID Number: 05/2006e

ClinicalTrials.gov Identifier: NCT00502281

Health Authority: Italy: The Italian Medicines Agency