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

Phase 4
18 Years
35 Years
Not Enrolling
Polycystic Ovary Syndrome

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Trial Information

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Pregnancy rate

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Stefano Palomba, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Obstetrics & Gynecology, University "Magna Graecia" of Catanzaro


Italy: The Italian Medicines Agency

Study ID:




Start Date:

January 2007

Completion Date:

Related Keywords:

  • Polycystic Ovary Syndrome
  • Gonadotropins
  • Infertility
  • Intrauterine insemination
  • PCOS
  • Timed intercourse
  • Treatment
  • Polycystic Ovary Syndrome