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Galectin-3 in Patients With Endometriosis

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ClinicalTrials.gov Identifier: NCT03212612
Recruitment Status : Not yet recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Heba Magdy Mohammed, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment
Endometriosis Diagnostic Test: samples obtained by laparoscopy or punch biopsy for analysis by ELISA

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Galectin-3 in Patients With Endometriosis
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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




Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
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


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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Criteria

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.


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): NCT03212612


Locations
Egypt
Faculty of Medicine - Assiut University Not yet recruiting
Assiut, Egypt
Contact: Heba Magdy Mohammed    0882349135    hebamagdy990@yahoo.com   
Faculty of Medicine -Assiut University Not yet recruiting
Assiut, Egypt
Contact: heba magdy mohammed    0882349135    hebamagdy990@yahoo.com   
Contact: mona abd el-hamid hassan    01005800409    monaelbaz1@gmail.com   
Faculty of Medicine- Assiut University Not yet recruiting
Assiut, Egypt
Contact: heba magdy mohammed    0882349135    hebamagdy990@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: heba magdy mohammed faculty of medicine -aasiut university

Publications of Results:
Responsible Party: Heba Magdy Mohammed, galectin-3 in women with endometriosis, Assiut University
ClinicalTrials.gov Identifier: NCT03212612     History of Changes
Other Study ID Numbers: 17100222
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Heba Magdy Mohammed, Assiut University:
Galectin-3 ,endometrosis

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female