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

NCT ID: NCT01738932

Last Updated: 2012-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Endometriosis

Keywords

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endometriosis mannan-binding lectin immunology

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients

women with histologically verified endometriosis

No interventions assigned to this group

Controls

Healthy Danish blood donors

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* histologically verified endometriosis
* ASRM stage 2-4

Exclusion Criteria

* pregnancy
* actual treatment with GnRh analog
* autoimmune diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina Kruse, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aarhus University Hospital, Department of Gynecology and Obstetrics

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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. doi: 10.1016/j.fertnstert.2005.10.032. Epub 2006 Apr 5.

Reference Type RESULT
PMID: 16600231 (View on PubMed)

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.

Reference Type RESULT
PMID: 19917506 (View on PubMed)

Other Identifiers

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MBLendo06

Identifier Type: -

Identifier Source: org_study_id