Prevalence of Endometriosis in a Well Defined Group of Infertile Women

Sponsor

University Hospital, Gasthuisberg (Other)

Overall Status

Completed

CT.gov ID

NCT00464139

Collaborator

(none)

221

Enrollment

Location

Duration (Months)

217

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis Infertility	Procedure: Laparoscopy

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.

Study Design

Study Type:

Observational

Actual Enrollment :

221 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

The diagnosis of endometriosis was made by the fertility surgeon of the LUFC. [2003 - 2006]

Secondary Outcome Measures

The diagnosis of endometriosis was always confirmed by histological examination. [2003 - 2006]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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