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Fertility Surgery, Prospective Analysis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by University Hospital, Gasthuisberg.
Recruitment status was:  Recruiting
Information provided by:
University Hospital, Gasthuisberg Identifier:
First received: April 18, 2007
Last updated: August 31, 2010
Last verified: August 2010
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.


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

Resource links provided by NLM:

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 ]

Biospecimen Retention:   Samples Without DNA
Endometriosis is confirmed by histologic 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)
Patients operated at the LUFc
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.

Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes 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.

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
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Please refer to this study by its identifier: NCT00463398

University Hospital Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christel Meuleman, MD, University Hospital, Gasthuisberg, Leuven, Belgium Identifier: NCT00463398     History of Changes
Other Study ID Numbers: ML2818 - 20/02/2006 b 
Study First Received: April 18, 2007
Last Updated: August 31, 2010

Keywords provided by University Hospital, Gasthuisberg:
Fertility Surgery
Quality of Life
Sexual Function
Health economics

Additional relevant MeSH terms:
Genital Diseases, Female processed this record on February 20, 2017