Galectin-3 in Patients With Endometriosis

July 6, 2017 updated by: Heba Magdy Mohammed, Assiut University
The exact cause of endometriosis is unknown ,so our study is to investigate the relationship between Galectin-3 and endometriosis by comparing between its level in healthy and endometriosis women. Also, we will measure the level of oxidative stress markers in endometrium of both healthy and endometriosis women and investigate the correlaton between them and galectin-in endometriosis women.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Endometriosis is a benign gynaecological disorder with malignant biological characteristics and is defined by the presence of endometrial glands and stroma outside the uterine cavity. Ectopic endometrial cells can spread to pelvic organs such as rectum, bladder, and ovaries. The pathophysiology of endometriosis is likely to be multifactorial and to involve an interplay between several factors. (Fauser BC, Diedrich K, Bouchard P, Domínguez F, Matzuk M, 2011)

The endometrial cycle and implantation are complex processes. Alterations in levels of some regulatory molecules on the cell surface occur during the cycle tightly controlled proliferation and differentiation. Most of these regulatory molecules and mechanisms have not yet been investigated, However, Galectins , a sub family of lectins are delineated to regulate vital cell functions. (Leffler H. et al Introduction to galectins. Glycoconj j,2004) It has been shown that Gal-3 is expressed in many cell types, including endometrial cells and trophoblast cells (Riss D, Naude S 2003) . Previous studies have reported that Gal-3 is specifically expressed in endometrial cells in the secretory phase, in placental tissue during early pregnancy, and in decidua surrounding the site of implantation. Another study verified that Gal-3 plays an important role in the process of embryonic implantation (Liu YK, Hum Reprod.2009). Intracellular Gal-3 promoted proliferation and adhesion in endometrial cells(Yang H, TaylorHS,2011) .

Female reproductive system is vulnerable to the harmful effects of reactive oxygen species (ROS) that damage proteins, lipids, and DNA structure. Oxidative stress is a key factor for progression of endometriosis. Many theories have been elaborated so far to clarify endometriosis pathogenesis and oxidative stress, a result of increased production of free radicals or depletion of the body's endogenous antioxidant defense, has been implicated in its pathogenesis.

Our study is a case-control study that will be made in woman health hospital and medical biochemistry department -assiut university. We will estimate the tissue level of galectin-3 in endometrium of both healthy and endometriosis women and detect wether galectin-3 leads to or protect against endometriosis. Also, we will measure the level of oxidative stress markers in endometrium of both healthy and endometriosis women and investigate the correlaton between them and galectin-in endometriosis women.

The sample size is calculated by Epi Info 2000 software computer program. Based on the expected proportion of Galectin-3 deficiency among controls will be 20% and its increase in cases by four folds (Odd Ratio = 4) with 80% power and a confidence level 95%, the calculated sample size is 45cases and 45 controls (totally 90 women).

The data collected will include age, parity, menstrual history , present history (including symptoms of pain, bleeding and infertility), drug history , history of previous diseases and any investigations were done. The aim of the study will be explained to each participant before filling study sheet. A written consent will be obtained from those who welcome to participate in the study, then women will be divided into 2 groups.

Group1:

45women who were found to have surgically and histolopathologically -confirmed endometriosis. Endometrial samples(1-2 gram) will be taken by laparoscopy which is the gold standard for definitive diagnosis of endometriosis.

Group2:

45 women free of endometriosis. These women had normal menstrual cycles and had not received hormonal therapy within 3 months prior to sampling. Endometrial samples(1-2 gram) will be taken from them through Punch biopsy after IUD insertion.

Galectin-3 will be estimated by ELISA kit. Endometrial samples(1-2 gram) will be separated from each women during proliferative phase(days 5-15) and washed several times with 0.9% sterile saline solution to remove any blood from the tissues. The tissue samples will homogenized by tissue homogenizer at 40,000rpm. The supernatant extracts will be collected in Ependorf tubes and frozen at -80°C till analysis by ELISA.

The tissue levels of NO and TBARS (oxidative stress markers) were determined by chemical methods according to the methods descriped by Van Bezooijen et al, (1998), and Buege and Aust (1978) respectively. Also the tissue levels of catalase (CAT), glutathione (GSH) and superoxide dismutase (SOD) activity (anti oxidants) were determined by chemical methods according to the methods descriped by Clairborne ( 1985), Beutler et al. (1963) and Marklund (1985).

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Faculty of Medicine - Assiut University
        • Contact:
      • Assiut, Egypt
        • Faculty of Medicine -Assiut University
        • Contact:
        • Contact:
      • Assiut, Egypt
        • Faculty of medicine- Assiut university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The study will include women aged from 20 to 35 years old in woman health hospital.

The aim of the study will be explained to each participant before filling study sheet. A written consent will be obtained from those who welcome to participate in the study .The data collected will include age, parity, menstrual history , present history (including symptoms of pain, bleeding and infertility), drug history , history of previous diseases and any investigations were done. Then women will be divided into 2 groups, (group of cases and a control group)

Description

Inclusion Criteria:

Age:20-35 years In women with endometriosis

Exclusion Criteria:

Women who have irregular menstrual cycles

Women who are pregnant, have pelvic inflammatory disease, cervical erosion, vaginal infection or coagulopathies.

Women who have liver disease, renal disease or cardiac disease that can affect level of Galectin-3.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
2 groups , control and cases

Groupe 1: (cases) 45 women who were found to have surgically and histolopathologically -confirmed endometriosis. Endometrial samples(1-2 gram) will be taken by laparoscopy which is the gold standard for definitive diagnosis of endometriosis.

Group2:(control) 45women who were free of endometriosis. Endometrial samples(1-2 gram) will be taken by punch biopsy.
Diagnostic test: samples obtained by laparoscopy or punch biopsy for analysis by ELISA
Endometrial samples(1-2 gram) will be separated from each women during proliferative phase(days 5-15) by laparoscopy or punch biopsy and washed several times with 0.9% sterile saline solution to remove any blood from the tissues. The tissue samples will homogenized by tissue homogenizer at 40,000rpm. The supernatant extracts will be collected in Ependorf tubes and frozen at -80°C till analysis by ELISA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the level of Galectin-3 proteins in patients of endometriois and investigate the relationship between Galectin-3 and endometriosis by comparing between its level in healthy and endometriosis women.
Time Frame: 6 months
galectin-3 level will be estimated in both healthy and endometriosis women by ELISA to iinvestigate the role of galectin-3 in etiology of endometriosis
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: heba magdy mohammed, faculty of medicine -aasiut university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2017

Primary Completion (ANTICIPATED)

January 1, 2018

Study Completion (ANTICIPATED)

April 1, 2018

Study Registration Dates

First Submitted

July 6, 2017

First Submitted That Met QC Criteria

July 6, 2017

First Posted (ACTUAL)

July 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 11, 2017

Last Update Submitted That Met QC Criteria

July 6, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17100222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometriosis

Clinical Trials on samples obtained by laparoscopy or punch biopsy for analysis by ELISA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe