Fertility Surgery, Prospective Analysis - Full Text View

Sponsored by:	University Hospital, Gasthuisberg
Information provided by:	University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:	NCT00463398

Purpose

From September 2006 a prospective cohort study is conducted among all patients operated at the Leuven University Fertility Centre to evaluate clinical and economical outcome after CO2 laser laparoscopic fertility surgery.

Condition
Endometriosis

MedlinePlus related topics: Endometriosis Infertility

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Quality Control in Surgical Diagnosis and Treatment of Endometriosis.

Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:

complication rate, quality of life, pain, sexual activity, economic life circumstances, pregnancy rate, reintervention rate, recurrence rate [ Time Frame: 1 month preop, 6 - 12 - 18 and 24 months postop ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Endometriosis is confirmed by histollogic examination of excised lesions

Estimated Enrollment:	600
Study Start Date:	September 2006
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 All patients operated at the Leuven University Fertility Centre (LUFc) between september 2006 and August 2008.

Detailed Description:

The main outcome measurements are postoperative complications, pain, quality of life, sexual satisfaction, economic life circumstances, cumulative pregnancy rate and cumulative recurrence rate of endometriosis.

Eligibility

Ages Eligible for Study:	19 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All patients operated at the Leuven University Fertility Centre (LUFc) between september 2006 and August 2008.

Criteria

Inclusion Criteria:

All patients
operated at the Leuven University Fertility Centre of the Department of Obstetrics and Gynaecology of the University Hospitals Leuven, Leuven,Belgium,
from September 2006 to August 2008.

Exclusion Criteria:

patients of other than the Dutch language

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463398

Contacts

Contact: Christel LC Meuleman, MD	+32 16 34 36 24	Christel.Meuleman@uz.kuleuven.be
Contact: Thomas D'Hooghe, MD, PhD	+32 16 34 36 24	Thomas.D'Hooghe@uz.kuleuven.be

Locations

Belgium
University Hospital Leuven	Recruiting
Leuven, Belgium, 3000
Contact: Christel LC Meuleman, MD +32 16 34 36 24 Christel.Meuleman@uz.kuleuven.be
Contact: Thomas D'Hooghe, MD, PhD +32 16 34 36 24 Thomas.dhooghe@uz.kuleuven.be
Principal Investigator: Christel LC Meuleman, Md
University Hospital Leuven	Recruiting
Leuven, Belgium, 3000
Contact: Christel LC Meuleman, MD +32 16 34 36 24 Christel.Meuleman@uz.kuleuven.be
Contact: Thomas D'Hooghe, MD, PhD +32 16 34 36 24 Thomas.dhooghe@uz.kuleuven.be
Principal Investigator: Christel LC Meuleman, MD

Sponsors and Collaborators

University Hospital, Gasthuisberg

Investigators

Principal Investigator:	Christel LC Meuleman, MD	University Hospital Gasthuisberg, Catholic University, Leuven, Belgium
Study Director:	Thomas D'Hooghe, MD, PhD	University Hospital Gasthuisberg, Catholic University, Leuven, Belgium

More Information

Responsible Party:	University Hospitals Leuven, Belgium ( Christel Meuleman, MD )
Study ID Numbers:	ML2818 - 20/02/2006 b
Study First Received:	April 18, 2007
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00463398
Health Authority:	Belgium: Institutional Review Board

Keywords provided by University Hospital, Gasthuisberg:

Endometriosis
Fertility Surgery
Quality of Life
Pain

Sexual Function
Health economics
Recurrence
Pregnancy

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Quality of Life

Endometriosis
Pain
Recurrence

ClinicalTrials.gov processed this record on January 16, 2009