Clinical trial NCT01738932: Genetic Polymorphisms of Mannan-binding Lectin (MBL)and Serum Levels of MBL in Patients With Endometriosis
Official title: Genetic Polymorphisms of Mannan-binding Lectin (MBL) and Serum Levels of MBL in Patients With Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: endometriosis
mannan-binding lectin
immunology
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
First posted: 2012-11-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Endometriosis patients referred to the endometriosis clinic at Aarhus University Hospital

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

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 criteria: Inclusion Criteria:

* histologically verified endometriosis
* ASRM stage 2-4

Exclusion Criteria:

* pregnancy
* actual treatment with GnRh analog
* autoimmune diseases

Primary outcomes:
measure: Frequency of individuals with s-MBL < 100 ng/ml
timeFrame: baseline
measure: Frequency of individuals with MBL genotypes LXPA/O or O/O
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Gynecology and Obstetrics
Study officials:
affiliation: Aarhus University Hospital
name: Christina Kruse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.