NCT00464139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
Last Updated

February 20, 2009

Status Verified

February 1, 2009

Enrollment Period

1 month

First QC Date

April 18, 2007

Last Update Submit

February 19, 2009

Conditions

EndometriosisInfertility

Keywords

endometriosisprevalencefertilitypainultrasound

Outcome Measures

Primary Outcomes (1)

  • The diagnosis of endometriosis was made by the fertility surgeon of the LUFC.

    2003 - 2006

Secondary Outcomes (1)

  • The diagnosis of endometriosis was always confirmed by histological examination.

    2003 - 2006

Study Arms (1)

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

Interventions

LaparoscopyPROCEDURE

Laparoscopy

Also known as: diagnostic laparoscopy, CO2 laser operative laparoscpy
1

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • a previous laparoscopic diagnosis of endometriosis before referral to our centre

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Gasthuisberg

Leuven, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

EndometriosisInfertilityPain

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Christel LC Meuleman, MD

    University Hospital Gasthuisberg, Leuven, Belgium

    PRINCIPAL INVESTIGATOR

  • Thomas D'Hooghe, MD, PhD

    University Hospital Gasthuisberg, Leuven, Belgium

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 20, 2007

Study Start

January 1, 2007

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

February 20, 2009

Record last verified: 2009-02

Locations

BE(1)