InfertilityEMJNCT02295917
Computerized Evaluation of the Endometrial Myometrial Junction During a Natural Menstrual Cyle.
An observational study of Infertility, run by Meir Medical Center.
Trial summary
The investigators aim to evaluate the width of the endometrial myometrial zone in participants during natural menstrual cycle by using specific computerized application on 3 dimensions sonographic images of their uteri. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Transvaginal sonography
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Jul 2015
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: patients referred for transvaginal sonography
Who may be able to join
- Exclusion Criteria:patients on contraceptive pills.patients after uterine surgery
- -
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Investigators Aim to Evaluate the Width of the Endometrial Myometrial Zone in Participants During Natural Menstrual Cycle by Using Specific Computerized Application on 3 Dimensions Sonographic Images of Their Uteri
The investigators aim to evaluate the width of the endometrial myometrial zone in participants during natural menstrual cycle by using specific computerized application on 3 dimensions sonographic images of their uteri.
Read the detailed description
The uterine endometrium and the uterine myometrium have different acoustic characterization in transvaginal ultrasound(TVS).TVS can also demonstrate the interface between these tissues - the endometrial myometrial zone(EMJ) .This is optimally achieved in 3 dimensions images in a coronal section of the uterus.A specific computerized algorithm was developed in our unit by using MATLAB software for the quantitative measurements of the EMJ width in different uterine planes.The investigators aim to evaluate changes in the width of the EMJ in different uterine planes in participants during natural menstrual cycle .
- Conditions
- Infertility
- Being tested
- Transvaginal sonography
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal sonographyDevice
Transvaginal sonography
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the width of the EMJ during natural cycle
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronnie Tepper, Meir Medical Center
- Investigators
- Rami Aviram, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295917
- Sponsor's protocol ID
- 0074-13-MMC
- Acronym
- EMJ
- Status last verified
- Nov 2014
- First submitted
- 18 Nov 2014
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigators Aim to Evaluate the Width of the Endometrial Myometrial Zone in Participants During Natural Menstrual Cycle by Using Specific Computerized Application on 3 Dimensions Sonographic Images of Their Uteri
- ClinicalTrials.gov ID
- NCT02295917
- Acronym / sponsor ID
- EMJ / 0074-13-MMC
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 20 Nov 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.
The investigators aim to evaluate the width of the endometrial myometrial zone in participants during natural menstrual cycle by using specific computerized application on 3 dimensions sonographic images of their uteri.
Detailed description
The uterine endometrium and the uterine myometrium have different acoustic characterization in transvaginal ultrasound(TVS).TVS can also demonstrate the interface between these tissues - the endometrial myometrial zone(EMJ) .This is optimally achieved in 3 dimensions images in a coronal section of the uterus.A specific computerized algorithm was developed in our unit by using MATLAB software for the quantitative measurements of the EMJ width in different uterine planes.The investigators aim to evaluate changes in the width of the EMJ in different uterine planes in participants during natural menstrual cycle .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients referred for transvaginal sonography
Key inclusion criteria (2 listed)
- Exclusion Criteria:patients on contraceptive pills.patients after uterine surgery
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Transvaginal sonographyTransvaginal sonography | Device | – |
Primary outcome
Changes in the width of the EMJ during natural cycle
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 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.
Rami Aviram, MD principal investigator
Meir Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Meir Medical Center.
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 2 inclusion and 0 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 25 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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 Ronnie Tepper, MD (97297471074, tepper@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the width of the EMJ during natural cycle (time frame: 30 days). 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 25 Nov 2014; AzTrials last refreshed its copy on 6 Nov 2026.