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Prevalence of Endometriosis in a Well Defined Group of Infertile Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00464139
First Posted: April 20, 2007
Last Update Posted: February 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Gasthuisberg
  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 ]

Secondary Outcome Measures:
  • The diagnosis of endometriosis was always confirmed by histological examination. [ Time Frame: 2003 - 2006 ]

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

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Christel Meuleman, MD, University Hospitals Leuven
ClinicalTrials.gov Identifier: NCT00464139     History of Changes
Other Study ID Numbers: EC - 20/03/2007
First Submitted: April 18, 2007
First Posted: April 20, 2007
Last Update Posted: February 20, 2009
Last Verified: February 2009

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

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