Genetic Polymorphisms of Mannan-binding Lectin (MBL)and Serum Levels of MBL in Patients With Endometriosis

This study has been completed.
Sponsor:
Collaborator:
Aalborg Universityhospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01738932
First received: November 28, 2012
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

The purpose of the study is to investigate the possible association between low levels of MBL and the development of endometriosis


Condition
Endometriosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Genetic Polymorphisms of Mannan-binding Lectin (MBL) and Serum Levels of MBL in Patients With Endometriosis

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Frequency of individuals with s-MBL < 100 ng/ml [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Frequency of individuals with MBL genotypes LXPA/O or O/O [ Time Frame: baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum, EDTA blood


Enrollment: 100
Study Start Date: December 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients
women with histologically verified endometriosis
Controls
Healthy Danish blood donors

Detailed Description:

Endometriosis is a chronic, inflammatory disease, affecting approximately 10% of the female population. The pathogenesis of endometriosis is still unclear, but several studies have indicated that the immune system is involved. It has been suggested that endometriosis should be considered an autoimmune disease, considering the findings of elevated levels of cytokines, decreased cell apoptosis, increased incidence of autoantibodies and a higher frequency of other autoimmune diseases in endometriosis patients. MBL participates in the innate immune defence by activating complement on the surfaces of microorganisms, but several studies have suggested that MBL is also involved in autoimmune diseases. The individual MBL level is highly variable due to a number of polymorphic sites in the structural gene and in the promoter region, and approximately 12 % of the normal population have very low serum MBL levels (<100 ng/ml).

The possible association between MBL and endometriosis has been investigated in two small studies, in which no association was found. The aim of the present study is to investigate the prevalence of individuals with low serum levels of MBL and with genotypes associated with low MBL production in a larger group of endometriosis patients.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Endometriosis patients referred to the endometriosis clinic at Aarhus University Hospital

Criteria

Inclusion Criteria:

  • histologically verified endometriosis
  • ASRM stage 2-4

Exclusion Criteria:

  • pregnancy
  • actual treatment with GnRh analog
  • autoimmune diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738932

Locations
Denmark
Aarhus University Hospital, Department of Gynecology and Obstetrics
Aarhus, Denmark, 8200 N
Sponsors and Collaborators
University of Aarhus
Aalborg Universityhospital
Investigators
Principal Investigator: Christina Kruse, PhD Aarhus University Hospital
  More Information

Publications:
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01738932     History of Changes
Other Study ID Numbers: MBLendo06
Study First Received: November 28, 2012
Last Updated: November 29, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
endometriosis
mannan-binding lectin
immunology

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 22, 2014