Endometriosis, OvarianNCT02103452
Edessy Stem Cell Score (ESS), Endometrium, Endometrioma
A study testing Ovarian and endometrial samples in people with Endometriosis, Ovarian, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Purpose of this study is to evaluate stem cell expression (SCE) in endometriotic (E) and non endometriotic ovarian and endometrial tissues. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Endometriosis, Ovarian
- What is being tested?
- Ovarian and endometrial samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2012to Oct 2013
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 20 to 40 years and did not receive hormonal treatment for three month
Who cannot join
- Diabetes mellitus, cardiovascular and kidney diseases, adenomyosis, Uterine fibroid Endometrial carcinoma and Poly cystic ovary
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Edessy STEM CELL SCORE (ESS), Endometrium, Endometrioma
Purpose of this study is to evaluate stem cell expression (SCE) in endometriotic (E) and non endometriotic ovarian and endometrial tissues.
Read the detailed description
This study was conducted on 40 women at Al-Azhar University Hospitals. They are divided into two equal groups, group 1 with ovarian endometrioma and group 2 with normal ovary. Ovarian and endometrial samples were evaluated by hematoxlin \& eosin for histopathology (HP) and of oct-4 for immunohistochemistry (IH) for SCE.
Evaluation of IH parameters revealed that the most important factors for evaluating SC were arranged as score ( Edessy Stem Cell Score=ESS).
- Conditions
- Endometriosis, Ovarian
- Being tested
- Ovarian and endometrial samples
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovarian and endometrial samplesProcedure or surgery
Ovarian and endometrial samples were evaluated by hematoxlin \&eosin for histopathology (HP) and of oct-4 for immunohistochemistry (IH) for SCE
| Study group | Role | What they receive |
|---|---|---|
| ovarian endometrioma | Experimental | Ovarian and endometrial samples Receives: Procedure: Ovarian and endometrial samples |
| normal ovary | Experimental | Ovarian and endometrial samples Receives: Procedure: Ovarian and endometrial samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edessy Stem Cell Score (ESS)
ESS
- Intensity of stem cell marker: Negative to mild =0, Moderate =1, Strong =2
- Percentage of stained cells: 0 =0, 0-50%= 1, >50-100% =2.
- Focality : None =0, Focal =1, Diffuse= 2
- Distribution: None= 0, Epithelial or mesenchymal= 1, Epithelial and mesenchymal= 2.
- Localization of positive stained cell: None=0, Cytoplasmic or nuclear =1, Cytoplasmic and nuclear= 2
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis, OvarianStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edessy Mahmoud, Al-Azhar University
- Investigators
- Mahmoud Edessy, MD, Principal investigator, Al-Azhar UniversityHala hosni, MD, Study director, Cairo UniversityMagdy Olama, MD, Study director, Al-Azhar UniversityMohammad A Sattar, MD, Study chair, Al-Azhar UniversityAhmad Monir, MSc, Study chair, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103452
- Sponsor's protocol ID
- 17819555
- Status last verified
- Mar 2014
- First submitted
- 26 Mar 2014
- Last updated
- 4 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edessy STEM CELL SCORE (ESS), Endometrium, Endometrioma
- ClinicalTrials.gov ID
- NCT02103452
- Acronym / sponsor ID
- 17819555
- Conditions
- Endometriosis, Ovarian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of this study is to evaluate stem cell expression (SCE) in endometriotic (E) and non endometriotic ovarian and endometrial tissues.
Detailed description
This study was conducted on 40 women at Al-Azhar University Hospitals. They are divided into two equal groups, group 1 with ovarian endometrioma and group 2 with normal ovary. Ovarian and endometrial samples were evaluated by hematoxlin \& eosin for histopathology (HP) and of oct-4 for immunohistochemistry (IH) for SCE.
Evaluation of IH parameters revealed that the most important factors for evaluating SC were arranged as score ( Edessy Stem Cell Score=ESS).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ovarian endometrioma | Experimental | Procedure: Ovarian and endometrial samplesOvarian and endometrial samples |
| normal ovary | Experimental | Procedure: Ovarian and endometrial samplesOvarian and endometrial samples |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 20 to 40 years and did not receive hormonal treatment for three month
Key exclusion criteria (1 listed)
- Diabetes mellitus, cardiovascular and kidney diseases, adenomyosis, Uterine fibroid Endometrial carcinoma and Poly cystic ovary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ovarian and endometrial samplesOvarian and endometrial samples were evaluated by hematoxlin \&eosin for histopathology (HP) and of oct-4 for immunohistochemistry (IH) for SCE | Procedure or surgery | normal ovary, ovarian endometrioma |
Primary outcome
Edessy Stem Cell Score (ESS)
Time frame: 1 week
ESS * Intensity of stem cell marker: Negative to mild =0, Moderate =1, Strong =2 * Percentage of stained cells: 0 =0, 0-50%= 1, >50-100% =2. * Focality : None =0, Focal =1, Diffuse= 2 * Distribution: None= 0, Epithelial or mesenchymal= 1, Epithelial and mesenchymal= 2. * Localization of positive stained cell: None=0, Cytoplasmic or nuclear =1, Cytoplasmic and nuclear= 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Edessy, MD principal investigator
Al-Azhar University
Hala hosni, MD study director
Cairo University
Magdy Olama, MD study director
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovarian and endometrial samples in people with Endometriosis, Ovarian, run by Al-Azhar University at 1 site 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 1 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: finished, as of the sponsor's last update on 4 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edessy Stem Cell Score (ESS) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2014.