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The Immune Base of Endometriosis

This study has been withdrawn prior to enrollment.
(The study was withrawn do to logistic difficulties)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370123
First Posted: August 30, 2006
Last Update Posted: June 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose

Endometriosis is a chronic disabling inflammatory disease which effects 15-20% of women in their reproductive life.

In patients suffering from endometriosis retrograded menstrual cells induce an inflammatory response.Endometriosis has also been considered to be an autoimmune disease, owing to the presence of auto antibodies, the association with other autoimmune diseases and recurrent immune-mediated abortion.

We aim to study this aberrant regulation of endometrial cell apoptosis by investigating the peripheral blood immune system of patients suffering from endometriosis.

Hypothesis:

We hypothesized that immune peripheral mononuclear cells of patients suffering from pelvic endometriosis react differently to eutopic endometrial cells than matched control women group. This difference could be study on a molecular, antigenic and/or apoptotic cycle gene expression. We also hypothesized that a deficiency of regulatory T cells is associated with the progression of endometriosis.


Condition
Endometriosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: In This Study we Aim to Explore the Immune Nature of Endometriosis as Manifested in the Peripheral Blood, Endometriosis Lesions, Normal Peritoneum and Normal Endometrium of Patients Suffering From Documented Endometriosis.

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 50
Study Start Date: September 2006
Detailed Description:

Endometriosis affects 15-20% of women in their reproductive life. Endometriosis is a chronic disabling inflammatory disease, characterized by implantation and growth of endometrial tissue (glandular epithelium and stroma) outside the uterine cavity.

Retrograde menstruation was found in 80%-90% of women. In most women these endometrial cells undergo apoptosis. In patients suffering from endometriosis this cells induce an inflammatory response. Pelvic endometriosis is associated with intrinsic anomalies of the refluxed endometrium, increased secretion of pro-inflammatory cytokines, neoangiogenesis, and impaired function of cell-mediated natural immunity.

Endometriosis has also been considered to be an autoimmune disease, owing to the presence of auto antibodies, the association with other autoimmune diseases and recurrent immune-mediated abortion.

Evidence suggests that Foxp3-expressing CD4+CD25+ regulatory T cells play a crucial role in the suppression of inflammatory disease. However, their role in the suppression of endometriosis has not yet been addressed.

We aim to study this aberrant regulation of endometrial cell apoptosis by investigating the peripheral blood immune system of patients suffering from endometriosis.

Hypothesis:

We hypothesized that immune peripheral mononuclear cells of patients suffering from pelvic endometriosis react differently to eutopic endometrial cells than matched control women group. This difference could be study on a molecular, antigenic and/or apoptotic cycle gene expression. We also hypothesized that a deficiency of regulatory T cells is associated with the progression of endometriosis.

Study design:

This is an open labeled prospective in vitro study for two years.

Patients:

50 Patients suffering from endometriosis undergoing laparoscopy will be compared to 50 patients undergoing laparoscopy for other reasons.

Methods:

1. Blood withdrawal and pipelle endometrial cells harvesting 2. Isolation of peripheral blood mononuclear cells (PBMC) 3. Generation of T cell lines (from patients) 4. Measurement of cytokines 5. Determination of T- cell subsets by flow cytometry 5. PMNC and T cell lines will be frozen in liquid nitrogen and stored at-70C for future studies.

6. Endometrial tissue will be served ad antigenic source to generated T cell lines and the remnants will be stored at-70C for future studies.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
women of childbrearing age suffering from endometriosis and undergoing laparoscopy
Criteria

Inclusion Criteria:

  • laparoscopically proven endometriosis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370123


Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Chair: Mati Mandel, MD Sheba Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00370123     History of Changes
Other Study ID Numbers: SHEBA-06-4251-RM-CTIL
First Submitted: August 29, 2006
First Posted: August 30, 2006
Last Update Posted: June 28, 2011
Last Verified: June 2011

Keywords provided by Sheba Medical Center:
endometriosis
apoptosis
regulatory T cells

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female