Prevalence of Endometriosis in a Well Defined Group of Infertile Women

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00464139
First received: April 18, 2007
Last updated: February 19, 2009
Last verified: February 2009
  Purpose

At the Leuven University Fertility Centre (LUFC) of the Department of Obstetrics and Gynecology of the University Hospitals Leuven, Belgium, a retrospective epidemiological prevalence study based on an electronic search of patient files was performed to determine the prevalence of histologically proven endometriosis in a subset of infertile women with a regular cycle (variation 21 - 35 days), a partner with normal sperm and no previous surgical diagnosis of endometriosis.


Condition Intervention
Endometriosis
Infertility
Procedure: Laparoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: High Prevalence of Endometriosis in Infertile Women With Normal Ovulation and Normospermic Partners

Resource links provided by NLM:


Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • The diagnosis of endometriosis was made by the fertility surgeon of the LUFC. [ Time Frame: 2003 - 2006 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The diagnosis of endometriosis was always confirmed by histological examination. [ Time Frame: 2003 - 2006 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

The diagnosis of endometriosis was always confirmed by histological examination of the lesions excised.


Enrollment: 221
Study Start Date: January 2007
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1

The electronic files of all patients who consulted the LUFC since 2003 were searched to select women with at least 1 year of infertility, a regular cycle (variation 21 - 35 days), whose partner had normal sperm according to World Health Organization (WHO) criteria (n = 304).

After exclusion of 83 (27,3%) patients with a previous laparoscopic diagnosis of endometriosis before referral to our centre, 221 (72,7%) infertile women were included in our study.

Procedure: Laparoscopy
Laparoscopy
Other Names:
  • diagnostic laparoscopy
  • CO2 laser operative laparoscpy

Detailed Description:

In this study, the electronic files of all patients who consulted the LUFC since 2003 were searched to select women with at least 1 year of infertility, a regular cycle (variation 21 - 35 days), whose partner had normal sperm according to World Health Organization (WHO) criteria (n = 304).

After exclusion of 83 (27,3%) patients with a previous laparoscopic diagnosis of endometriosis before referral to our centre, 221 (72,7%) infertile women were included in our study.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The electronic files of all patients who consulted the LUFC since 2003 were searched to select women with at least 1 year of infertility, a regular cycle (variation 21 - 35 days), whose partner had normal sperm according to World Health Organization (WHO) criteria (n = 304).

After exclusion of 83 (27,3%) patients with a previous laparoscopic diagnosis of endometriosis before referral to our centre, 221 (72,7%) infertile women were included in our study.

Criteria

Inclusion Criteria:

  • all patients who consulted the LUFC since 2003
  • with at least 1 year of infertility,
  • a regular cycle (variation 21 - 35 days),
  • whose partner had normal sperm according to World Health Organization (WHO) criteria.

Exclusion Criteria:

  • a previous laparoscopic diagnosis of endometriosis before referral to our centre
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00464139

Locations
Belgium
University Hospital Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
Principal Investigator: Christel LC Meuleman, MD University Hospital Gasthuisberg, Leuven, Belgium
Study Director: Thomas D'Hooghe, MD, PhD University Hospital Gasthuisberg, Leuven, Belgium
  More Information

No publications provided

Responsible Party: Christel Meuleman, MD, University Hospitals Leuven
ClinicalTrials.gov Identifier: NCT00464139     History of Changes
Other Study ID Numbers: EC - 20/03/2007
Study First Received: April 18, 2007
Last Updated: February 19, 2009
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Gasthuisberg:
endometriosis
prevalence
fertility
pain
ultrasound

Additional relevant MeSH terms:
Endometriosis
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on August 28, 2014