NCT03212612

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

July 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

5 months

First QC Date

July 6, 2017

Last Update Submit

July 6, 2017

Conditions

Endometriosis

Keywords

Galectin-3 ,endometrosis

Outcome Measures

Primary Outcomes (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.

    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

Study Arms (1)

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

Interventions

samples obtained by laparoscopy or punch biopsy for analysis by ELISADIAGNOSTIC_TEST

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

2 groups , control and cases

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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)

You may qualify if:

  • Age:20-35 years In women with endometriosis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Faculty of Medicine - Assiut University

Asyut, Egypt

Location

Faculty of Medicine -Assiut University

Asyut, Egypt

Location

Faculty of Medicine- Assiut University

Asyut, Egypt

Location

Related Publications (1)

  • Yang H, Yin J, Ficarrotta K, Hsu SH, Zhang W, Cheng C. Aberrant expression and hormonal regulation of Galectin-3 in endometriosis women with infertility. J Endocrinol Invest. 2016 Jul;39(7):785-91. doi: 10.1007/s40618-016-0435-7. Epub 2016 Feb 17.

    PMID: 26886939RESULT

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

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • heba magdy mohammed

    faculty of medicine -aasiut university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
galectin-3 in women with endometriosis

Study Record Dates

First Submitted

July 6, 2017

First Posted

July 11, 2017

Study Start

August 1, 2017

Primary Completion

January 1, 2018

Study Completion

April 1, 2018

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations

EG(3)