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

NCT00502281 | Suspended Phase 4

• 1 other identifier: 05/2006e
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Gonadotropins; Infertility; Intrauterine insemination; PCOS; Timed intercourse; Treatment

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

  3 months

Secondary Outcomes (5)

• Abortion rate

  3 months

• Adverse events

  3 months

• OHSS

  3 months

• Multiple pregnancy rate

  3 months

• Costs

  3 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

COS followed by TI

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

Group B

ACTIVE COMPARATOR

COS followed by IUI

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

Interventions

highly purified urinary FSH DRUG

Group A; Group B

timed intercourses, intrauterine insemination BEHAVIORAL

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

Pugliese Hospital

Catanzaro, Catanzaro, CZ, 88100, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 17, 2007
• Study Start: January 1, 2007
• Primary Completion: March 1, 2013
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

IT (1)