NCT01738932

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
Last Updated

November 30, 2012

Status Verified

November 1, 2012

Enrollment Period

6 months

First QC Date

November 28, 2012

Last Update Submit

November 29, 2012

Conditions

Endometriosis

Keywords

endometriosismannan-binding lectinimmunology

Outcome Measures

Primary Outcomes (2)

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

    baseline

  • Frequency of individuals with MBL genotypes LXPA/O or O/O

    baseline

Study Arms (2)

Patients

women with histologically verified endometriosis

Controls

Healthy Danish blood donors

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Endometriosis patients referred to the endometriosis clinic at Aarhus University Hospital

You may qualify if:

  • histologically verified endometriosis
  • ASRM stage 2-4

You may not qualify if:

  • pregnancy
  • actual treatment with GnRh analog
  • autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Department of Gynecology and Obstetrics

Aarhus, 8200 N, Denmark

Location

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

    PMID: 16600231RESULT

  • 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.

    PMID: 19917506RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum, EDTA blood

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Christina Kruse, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2012

First Posted

November 30, 2012

Study Start

December 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

November 30, 2012

Record last verified: 2012-11

Locations

DK(1)