Prevalence of Endometriosis in a Well Defined Group of Infertile Women

Infertility Clinical Trial

Official title:

High Prevalence of Endometriosis in Infertile Women With Normal Ovulation and Normospermic Partners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464139
• Other study ID #: EC - 20/03/2007
• Status: Completed
• Phase: N/A
• First received: April 18, 2007
• Last updated: February 19, 2009
• Start date: January 2007
• Est. completion date: February 2007

Study information

• Verified date: February 2009
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Endometriosis
• Infertility

Intervention

Procedure:
• Laparoscopy
Laparoscopy

Locations

Country	Name	City	State
Belgium	University Hospital Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnosis of endometriosis was made by the fertility surgeon of the LUFC.		2003 - 2006	No
Secondary	The diagnosis of endometriosis was always confirmed by histological examination.		2003 - 2006	No