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EndometriosisNCT03212612

Galectin-3 in Patients With Endometriosis

An observational study of Endometriosis, run by Assiut University at 3 sites in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Endometriosis
What is being tested?
samples obtained by laparoscopy or punch biopsy for analysis by ELISA
How many people
90 participants
Where
3 sitesEgypt
Study dates
Aug 2017to Apr 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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)

Who may be able to join

  • Age:20-35 years In women with endometriosis

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Egypt3 sites
  • Faculty of Medicine - Assiut University

    Asyut

    Heba Magdy Mohammed, 0882349135, hebamagdy990@yahoo.com

  • Faculty of Medicine -Assiut University

    Asyut

    heba magdy mohammed, 0882349135, hebamagdy990@yahoo.com

    mona abd el-hamid hassan, 01005800409, monaelbaz1@gmail.com

  • Faculty of Medicine- Assiut University

    Asyut

    heba magdy mohammed, 0882349135, hebamagdy990@yahoo.com

Other trials in Egypt

About this study

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.

Read the 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).

Conditions
Endometriosis
Being tested
samples obtained by laparoscopy or punch biopsy for analysis by ELISA
Keywords
Galectin-3 ,endometrosis
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT03212612
Study groupRoleWhat they receive
2 groups , control and casesGroupe 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.
Receives: Diagnostic Test: samples obtained by laparoscopy or punch biopsy for analysis by ELISA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2017
  2. Study startAug 2017 (estimated)
  3. Primary completionJan 2018 (estimated)
  4. Study completionApr 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03212612
Sponsor's protocol ID
17100222
Status last verified
Jul 2017
First submitted
6 Jul 2017
Last updated
11 Jul 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26886939

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis, run by Assiut University at 3 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03212612, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.

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