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

Sponsor

University Magna Graecia (Other)

Overall Status

Suspended

CT.gov ID

NCT00502281

Collaborator

(none)

100

Enrollment

Location

Arms

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: highly purified urinary FSH Behavioral: timed intercourses, intrauterine insemination	Phase 4

Detailed 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

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A COS followed by TI	Drug: highly purified urinary FSH Behavioral: timed intercourses, intrauterine insemination
Active Comparator: Group B COS followed by IUI	Drug: highly purified urinary FSH Behavioral: timed intercourses, intrauterine insemination

Arm

Intervention/Treatment

Active Comparator: Group A

COS followed by TI

Drug: highly purified urinary FSH

Behavioral: timed intercourses, intrauterine insemination

Active Comparator: Group B

COS followed by IUI

Drug: highly purified urinary FSH

Behavioral: timed intercourses, intrauterine insemination

Outcome Measures

Primary Outcome Measures

Pregnancy rate [3 months]

Secondary Outcome Measures

Abortion rate [3 months]
Adverse events [3 months]
OHSS [3 months]
Multiple pregnancy rate [3 months]
Costs [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pugliese Hospital	Catanzaro	Catanzaro, CZ	Italy	88100

Sponsors and Collaborators

University Magna Graecia

Investigators

Principal Investigator: Stefano Palomba, MD, Department of Obstetrics & Gynecology, University "Magna Graecia" of Catanzaro
Principal Investigator: Francesco Orio, MD, Department of Endocrinology, University "Federico II" of Naples
Principal Investigator: Achille Tolino, MD, Department of Obstetrics & Gynecology, University "Federico II" of Naples