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WithdrawnNCT00370123Updated Jun 28, 2011

The Immune Base of Endometriosis

An observational study in Endometriosis, sponsored by Sheba Medical Center. Withdrawn. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-28.

Sponsored by Sheba Medical Center · Observational

Why this study was withdrawn
The study was withrawn do to logistic difficulties
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.

Read the 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.
  1. Endometrial tissue will be served ad antigenic source to generated T cell lines and the remnants will be stored at-70C for future studies.
02

Conditions studied

  • Endometriosis

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Keywords

  • endometriosis
  • apoptosis
  • regulatory T cells
03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's planned enrollment of 50 is below the median of 128 across 344 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

women of childbrearing age suffering from endometriosis and undergoing laparoscopy

Eligibility criteria

Inclusion Criteria:

  • laparoscopically proven endometriosis
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00370123
Lead sponsor
Sheba Medical Center
First posted
Aug 30, 2006
Start date
Sep 2006
Last update
Jun 28, 2011

Study contacts

Mati Mandel, MD
study chair · Sheba Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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