Endometrial DisorderNCT03351673
Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding
A study testing endometrial volume 2D TVS in people with Endometrial Disorder, run by Mansoura University at 1 site in Egypt.
Trial summary
Endometrial thickness has been used as an indicator of risk for endometrial hyperplasia and carcinoma in asymptomatic perimenopausal women. However, there is no cutoff value in perimenopausal women and the same thickness does not express the same endometrial volume in different endometrium because uterine lengths may… Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Endometrial Disorder
- What is being tested?
- endometrial volume 2D TVS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Aug 2017to Aug 2018
- 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 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- perimenopausal women with abnormal bleeding e.g. menorrhagia, metrorrhagia and polymenorrhea.
Who cannot join
- general or local causes of bleeding, drug intake or recent hormonal contraception
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
mansoura University
Al Mansurah, Dakahlia Governorate, 35516
hanan nabil, MD, 00201000571004, hanannobil00@yahoo.com
waleed Elrefaie, MD, 00201224515318, wrefaie@yahoo.com
About this study
Endometrial thickness has been used as an indicator of risk for endometrial hyperplasia and carcinoma in asymptomatic perimenopausal women. However, there is no cutoff value in perimenopausal women and the same thickness does not express the same endometrial volume in different endometrium because uterine lengths may be different and endometrial irregularities may exist. Many studies assessed endometrial volume measured by three-dimensional (3D) TVS as a predictor of malignancy in women with postmenopausal bleeding. To our knowledge there is no study assess endometrial volume measured by two dimension TVS in prediction of endometrial pathology, however it is cheap and available than 3D TVS.
- Conditions
- Endometrial Disorder
- Being tested
- endometrial volume 2D TVS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial volume 2D TVSDiagnostic test
calculation the endometrial volume using 2D ultrasound and correlation the results with the pathological findings of endometrial biopsy
| Study group | Role | What they receive |
|---|---|---|
| endometrial volume 2D TVS | Experimental | perimenopausal women who bleed are examined by 2D TVS and the calculated endometrial volume using a specific formula and followed by endometrial biopsy for correlation with the pathological findings Receives: Diagnostic Test: endometrial volume 2D TVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of measurement of endometrial volume by 2D TVS in prediction of endometrial pathology
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start8 Aug 2017
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial DisorderStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Nabil, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351673
- Sponsor's protocol ID
- Endometrial volume
- Status last verified
- Nov 2017
- First submitted
- 20 Nov 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding
- ClinicalTrials.gov ID
- NCT03351673
- Acronym / sponsor ID
- Endometrial volume
- Conditions
- Endometrial Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 24 Nov 2017 (actual)
- 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.
Endometrial thickness has been used as an indicator of risk for endometrial hyperplasia and carcinoma in asymptomatic perimenopausal women. However, there is no cutoff value in perimenopausal women and the same thickness does not express the same endometrial volume in different endometrium because uterine lengths may be different and endometrial irregularities may exist. Many studies assessed endometrial volume measured by three-dimensional (3D) TVS as a predictor of malignancy in women with postmenopausal bleeding. To our knowledge there is no study assess endometrial volume measured by two dimension TVS in prediction of endometrial pathology, however it is cheap and available than 3D TVS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endometrial volume 2D TVS | Experimental | Diagnostic Test: endometrial volume 2D TVSperimenopausal women who bleed are examined by 2D TVS and the calculated endometrial volume using a specific formula and followed by endometrial biopsy for correlation with the pathological findings |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- perimenopausal women with abnormal bleeding e.g. menorrhagia, metrorrhagia and polymenorrhea.
Key exclusion criteria (1 listed)
- general or local causes of bleeding, drug intake or recent hormonal contraception
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 |
|---|---|---|
| endometrial volume 2D TVScalculation the endometrial volume using 2D ultrasound and correlation the results with the pathological findings of endometrial biopsy | Diagnostic test | endometrial volume 2D TVS |
Primary outcome
accuracy of measurement of endometrial volume by 2D TVS in prediction of endometrial pathology
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endometrial volume 2D TVS in people with Endometrial Disorder, run by Mansoura 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: status not confirmed, as of the sponsor's last update on 27 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanan Nabil, MD (002/01000571004, hanannobil00@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of measurement of endometrial volume by 2D TVS in prediction of endometrial pathology (time frame: 1year). 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 27 Nov 2017.