Controlled Ovarian Stimulation Followed by Timed Intercourse or Intrauterine Insemination in Infertile PCOS Patients - Full Text View

Sponsor:	University Magna Graecia
Information provided by:	University Magna Graecia
ClinicalTrials.gov Identifier:	NCT00502281

Purpose

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	Intervention	Phase
Polycystic Ovary Syndrome	Drug: highly purified urinary FSH Behavioral: timed intercourses, intrauterine insemination	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Timed Intercourse Versus Intrauterine Insemination in Infertile Patients Undergoing Gonadotropin Ovarian Stimulation

Resource links provided by NLM:

MedlinePlus related topics: Infertility Polycystic Ovary Syndrome

U.S. FDA Resources

Further study details as provided by University Magna Graecia:

Primary Outcome Measures:

Pregnancy rate

Secondary Outcome Measures:

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

Estimated Enrollment:	100
Study Start Date:	January 2007
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502281

Contacts

Contact: Stefano Palomba, MD

+39-0961-883234

stefanopalomba@tin.it

Locations

Italy
Pugliese Hospital	Recruiting
Catanzaro, Catanzaro, CZ, Italy, 88100
Contact: , MD +39-0961-883234
Principal Investigator: Stefano Palomba, MD

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

More Information

No publications provided

Responsible Party:	Zullo Fulvio, University Magna Graecia of Catanzaro
ClinicalTrials.gov Identifier:	NCT00502281 History of Changes
Other Study ID Numbers:	05/2006e
Study First Received:	July 12, 2007
Last Updated:	November 2, 2010
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by University Magna Graecia:

Gonadotropins
Infertility
Intrauterine insemination

PCOS
Timed intercourse
Treatment

Additional relevant MeSH terms:

Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases

Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012