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Completed

NCT Number: NCT01738932

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

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

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Aarhus University Hospital, Department of Gynecology and Obstetrics

Aarhus, 8200 N, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • histologically verified endometriosis
  • ASRM stage 2-4

Exclusion criteria

  • pregnancy
  • actual treatment with GnRh analog
  • autoimmune diseases

Treatment and study plan

Primary outcomes

  1. Frequency of individuals with s-MBL < 100 ng/ml

    Time frame: baseline

  2. Frequency of individuals with MBL genotypes LXPA/O or O/O

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aalborg University Hospital

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 30, 2012
Registry last updated
Nov 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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