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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738932
• Other study ID #: MBLendo06
• Status: Completed
• Phase: N/A
• First received: November 28, 2012
• Last updated: November 29, 2012
• Start date: December 2006
• Est. completion date: June 2007

Study information

• Verified date: November 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• histologically verified endometriosis

• ASRM stage 2-4

Exclusion Criteria:

• pregnancy

• actual treatment with GnRh analog

• autoimmune diseases

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Gynecology and Obstetrics	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Kavoussi SK, Mueller MD, Lebovic DI. Expression of mannose-binding lectin in the peritoneal fluid of women with and without endometriosis. Fertil Steril. 2006 May;85(5):1526-8. Epub 2006 Apr 5. — View Citation

Ozerkan K, Oral B, Uncu G. Mannose-binding lectin levels in endometriosis. Fertil Steril. 2010 Jul;94(2):775-6. doi: 10.1016/j.fertnstert.2009.09.056. Epub 2009 Nov 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of individuals with s-MBL < 100 ng/ml		baseline	No
Primary	Frequency of individuals with MBL genotypes LXPA/O or O/O		baseline	No