|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03136978 |
|
Date of registration:
|
27/04/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Evaluation of M1 and M2 Macrophages in Endometriotic Tissue of Women Affected by Endometriosis at Different Stages.
|
|
Scientific title:
|
Evaluation of Evaluate M1 and M2 Macrophages in Endometriotic Tissue of Women Affected by Endometriosis at Different Stages. |
|
Date of first enrolment:
|
December 2016 |
|
Target sample size:
|
45 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03136978 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Antonio Simone Laganà , M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Messina |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients affected by histologically confirmed endometriosis (cases)
- Patients affected by ovarian function cysts (controls)
Exclusion Criteria:
- Other pelvic disorders (apart ovarian functional cysts)
- Chronic circulatory disorders
- Autoimmune disorders
- Neoplastic disorders
- Patients who were treated with any anti-inflammatory or hormonal or immunomodulatory
medication in the preceding 6 months.
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Endometriosis
|
|
Intervention(s)
|
|
Diagnostic Test: Evaluation of M1 and M2 macrophages by flow cytometry.
|
|
Primary Outcome(s)
|
|
Quantification of M1 and M2 macrophages in endometriotic tissue for each stage of endometriosis.
[Time Frame: Day 1]
|
|
Secondary Outcome(s)
|
|
Correlation of M1 and M2 macrophages quantity in endometriotic tissue to the presence of endometriosis-associated chronic pelvic pain.
[Time Frame: Day 1]
|
|
Correlation of M1 and M2 macrophages quantity in endometriotic tissue to the presence of endometriosis-associated infertility.
[Time Frame: Day 1]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|