EndometriosisNCT06821438
TVUS vs MRI Efficacy in Diagnosis of Laparoscopically Managed Patients With DIE
An observational study of Endometriosis, run by Alexandria University at 1 site in Egypt.
Trial summary
The purpose of the study is to compare the reliability and accuracy of systematic ultrasonographic scanning using International Deep Endometriosis Analysis group approach versus magnetic resonance imaging (MRI) assessment in diagnosis of patients with deep infiltrative endometriosis in comparison with the… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Laparoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2025to May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients with Deep Infiltrating Endometriosis affecting ovaries (endometriomas), rectosigmoid , bladder or any type of endometriosis who suffers from chronic pelvic pain, dysmenorrhea, dyspareunia, dyschasia, dysuria or infertility. All cases included were subjected to the following: History taking, analysis of complaint, physical examination , transvaginal sonography, MRI and laparoscopy. These are done after informed written consents.
Who may be able to join
- Known patient with Deep Infiltrating Endometriosis affecting ovaries (endometriomas), rectosigmoid , bladder or any type of endometriosis who suffers from chronic pelvic pain, dysmenorrhea, dyspareunia, dyschasia, dysuria or infertility.
Who cannot join
- Postmenopausal status.
- Women with malignancy or adnexal lesions other than suspected endometrioma.
- Those who were pregnant.
- History of any metallic implants or prosthesis preventing MRI. 5. Virgin cases (No Transvaginal Ultrasound).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tamer Hosny, Ph.D contact
About this study
Official title: PREOPERATIVE TRANSVAGINAL ULTRASOUND VERSUS MAGNETIC RESONANCE IMAGING IN DIAGNOSIS OF LAPAROSCOPICALLY MANAGED PATIENTS WITH DEEP INFILTRATING ENDOMETRIOSIS
The purpose of the study is to compare the reliability and accuracy of systematic ultrasonographic scanning using International Deep Endometriosis Analysis group approach versus magnetic resonance imaging (MRI) assessment in diagnosis of patients with deep infiltrative endometriosis in comparison with the intraoperative findings to confirm the accuracy.
Read the detailed description
Endometriosis is the existence of endometrial glands outside the uterus. About 10%- 12% of women who are menstruating have this benign gynecologic disease with peak age between 25 years and 35 years. However asymptomatic women can develop endometriosis lesions, and half of those suffering from infertility are found to have them. Endometriosis currently poses a significant problem because of its complexity, the range of clinical presentations it might take, and the still unknown physio-pathobiological genesis. There are three types of endometriosis; Deep Infiltrating Endometriosis, ovarian endometrioma, and superficial peritoneal endometriosis.
Deep infiltrating endometriosis is defined as the ectopic growth of endometrial glands and stroma extending more than 5 mm beneath the peritoneal surface. This type needs special and more vigorous management than the other types. It accounts for 15-30% of all the diagnosed endometriosis cases.
Ovarian endometrioma which is defined as "Endometrium-like tissue in the form of ovarian cysts "chocolate cysts". it is found in 2-10% of women in reproductive age and half of women receiving infertility treatment.
Superficial peritoneal endometriosis which is defined as "Endometrium- like tissue lesions involving the peritoneal surface. The lesions can have different appearances and color e.g. clear, black, etc.". It represent 15-50% of diagnosed cases.
This illness can cause crippling pain, infertility, and problems with bowel, sexual, and urine functions. These symptoms can have a major negative impact on a woman's quality of life during her reproductive years.
Because Deep Infiltrating Endometriosis tends to profoundly infiltrate pelvic systems, including several organs, ligaments, blood arteries, and nerves, it might mimic malignant processes despite being benign. Extensive and intricate dissection inside deep pelvic regions is necessary for the complicated excision of Deep Infiltrating Endometriosis in its aggressive form.
Noninvasive imaging modalities such as magnetic resonance imaging and transvaginal sonography are currently available for the diagnosis of Deep Infiltrating Endometriosis.
Regardless of its location, it is crucial to remember that there is significant variation in the stated sensitivity and specificity of transvaginal ultrasound for Deep Infiltrating Endometriosis detection.
The diagnosis of pelvic endometriosis is more accurate when an expert operator does an ultrasonography according to International Deep Endometriosis Analysis approach in addition to a pelvic examination and history.
When a woman has endometriosis, an ultrasound examination is performed to map the location of the disease, determine its severity, and attempt to explain the underlying symptoms before pursuing medication or surgery.
However, discrepancies in examination techniques, ultrasound equipment quality, and operator experience may account for discrepancies in the reported accuracy of the ultrasound diagnosis of Deep Infiltrating Endometriosis across different investigations.
MRI has a great degree of objectivity and the ability to capture pictures in various orientations over a wide field of view. The fusion of many Magnetic Resonance sequences can provide extensive information regarding the sites and histological aspects of endometriosis because of its superior contrast resolution.
The diagnosis is usually made through surgical visualization, ideally laparoscopy, although the recent guidelines from ESHRE suggest that actual imaging modalities for some types of endometriosis could be sufficient in the diagnosis process.
At present, there is no curative treatment for endometriosis, and clinical management of symptoms such as pain occurs through medical and/or surgical treatments .
Medical treatment follows the basic principle of suppression of menstrual cycles, resulting in the reduction in inflammation and blocking the effect of estrogens [Falcone 2018]. Unfortunately, current medical therapies could alleviate symptoms, but they are far from curative treatments and can often lead to side effects that compromise patient compliance.
Surgical treatment aims to remove bulky endometriotic lesions or, in more complex cases, complete excision of the pelvic organs. Neither the medical management nor the surgery turns out to give relief in the long term or is universally acceptable for the patients.
Laparoscopic observation and biopsy are very important in the diagnosis of Deep Infiltrating Endometriosis where the specimens biopsied are sent for histopathological examination for diagnosis of the nature of the lesions and their exact origin.
- Conditions
- Endometriosis
- Being tested
- Laparoscopy
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyProcedure or surgery
Endoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
TRANSVAGINAL ULTRASOUND VERSUS MAGNETIC RESONANCE IMAGING IN DIAGNOSIS OF LAPAROSCOPICALLY MANAGED PATIENTS WITH DEEP INFILTRATING ENDOMETRIOSIS
The purpose of the study is to compare the reliability and accuracy of systematic ultrasonographic scanning using International Deep Endometriosis Analysis group approach versus magnetic resonance imaging (MRI) assessment in diagnosis of patients with deep infiltrative endometriosis in comparison with intraoperative findings to confirm the diagnosis .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Hosny, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821438
- Sponsor's protocol ID
- US vs MRI in DIE
- Status last verified
- Feb 2025
- First submitted
- 5 Jan 2025
- Last updated
- 12 Feb 2025
- 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 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREOPERATIVE TRANSVAGINAL ULTRASOUND VERSUS MAGNETIC RESONANCE IMAGING IN DIAGNOSIS OF LAPAROSCOPICALLY MANAGED PATIENTS WITH DEEP INFILTRATING ENDOMETRIOSIS
- ClinicalTrials.gov ID
- NCT06821438
- Acronym / sponsor ID
- US vs MRI in DIE
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 12 Feb 2025 (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.
The purpose of the study is to compare the reliability and accuracy of systematic ultrasonographic scanning using International Deep Endometriosis Analysis group approach versus magnetic resonance imaging (MRI) assessment in diagnosis of patients with deep infiltrative endometriosis in comparison with the intraoperative findings to confirm the accuracy.
Detailed description
Endometriosis is the existence of endometrial glands outside the uterus. About 10%- 12% of women who are menstruating have this benign gynecologic disease with peak age between 25 years and 35 years. However asymptomatic women can develop endometriosis lesions, and half of those suffering from infertility are found to have them. Endometriosis currently poses a significant problem because of its complexity, the range of clinical presentations it might take, and the still unknown physio-pathobiological genesis. There are three types of endometriosis; Deep Infiltrating Endometriosis, ovarian endometrioma, and superficial peritoneal endometriosis.
Deep infiltrating endometriosis is defined as the ectopic growth of endometrial glands and stroma extending more than 5 mm beneath the peritoneal surface. This type needs special and more vigorous management than the other types. It accounts for 15-30% of all the diagnosed endometriosis cases.
Ovarian endometrioma which is defined as "Endometrium-like tissue in the form of ovarian cysts "chocolate cysts". it is found in 2-10% of women in reproductive age and half of women receiving infertility treatment.
Superficial peritoneal endometriosis which is defined as "Endometrium- like tissue lesions involving the peritoneal surface. The lesions can have different appearances and color e.g. clear, black, etc.". It represent 15-50% of diagnosed cases.
This illness can cause crippling pain, infertility, and problems with bowel, sexual, and urine functions. These symptoms can have a major negative impact on a woman's quality of life during her reproductive years.
Because Deep Infiltrating Endometriosis tends to profoundly infiltrate pelvic systems, including several organs, ligaments, blood arteries, and nerves, it might mimic malignant processes despite being benign. Extensive and intricate dissection inside deep pelvic regions is necessary for the complicated excision of Deep Infiltrating Endometriosis in its aggressive form.
Noninvasive imaging modalities such as magnetic resonance imaging and transvaginal sonography are currently available for the diagnosis of Deep Infiltrating Endometriosis.
Regardless of its location, it is crucial to remember that there is significant variation in the stated sensitivity and specificity of transvaginal ultrasound for Deep Infiltrating Endometriosis detection.
The diagnosis of pelvic endometriosis is more accurate when an expert operator does an ultrasonography according to International Deep Endometriosis Analysis approach in addition to a pelvic examination and history.
When a woman has endometriosis, an ultrasound examination is performed to map the location of the disease, determine its severity, and attempt to explain the underlying symptoms before pursuing medication or surgery.
However, discrepancies in examination techniques, ultrasound equipment quality, and operator experience may account for discrepancies in the reported accuracy of the ultrasound diagnosis of Deep Infiltrating Endometriosis across different investigations.
MRI has a great degree of objectivity and the ability to capture pictures in various orientations over a wide field of view. The fusion of many Magnetic Resonance sequences can provide extensive information regarding the sites and histological aspects of endometriosis because of its superior contrast resolution.
The diagnosis is usually made through surgical visualization, ideally laparoscopy, although the recent guidelines from ESHRE suggest that actual imaging modalities for some types of endometriosis could be sufficient in the diagnosis process.
At present, there is no curative treatment for endometriosis, and clinical management of symptoms such as pain occurs through medical and/or surgical treatments .
Medical treatment follows the basic principle of suppression of menstrual cycles, resulting in the reduction in inflammation and blocking the effect of estrogens [Falcone 2018]. Unfortunately, current medical therapies could alleviate symptoms, but they are far from curative treatments and can often lead to side effects that compromise patient compliance.
Surgical treatment aims to remove bulky endometriotic lesions or, in more complex cases, complete excision of the pelvic organs. Neither the medical management nor the surgery turns out to give relief in the long term or is universally acceptable for the patients.
Laparoscopic observation and biopsy are very important in the diagnosis of Deep Infiltrating Endometriosis where the specimens biopsied are sent for histopathological examination for diagnosis of the nature of the lesions and their exact origin.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with Deep Infiltrating Endometriosis affecting ovaries (endometriomas), rectosigmoid , bladder or any type of endometriosis who suffers from chronic pelvic pain, dysmenorrhea, dyspareunia, dyschasia, dysuria or infertility. All cases included were subjected to the following: History taking, analysis of complaint, physical examination , transvaginal sonography, MRI and laparoscopy. These are done after informed written consents.
Key inclusion criteria (1 listed)
- Known patient with Deep Infiltrating Endometriosis affecting ovaries (endometriomas), rectosigmoid , bladder or any type of endometriosis who suffers from chronic pelvic pain, dysmenorrhea, dyspareunia, dyschasia, dysuria or infertility.
Key exclusion criteria (4 listed)
- Postmenopausal status.
- Women with malignancy or adnexal lesions other than suspected endometrioma.
- Those who were pregnant.
- History of any metallic implants or prosthesis preventing MRI. 5. Virgin cases (No Transvaginal Ultrasound).
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 |
|---|---|---|
| LaparoscopyEndoscopy | Procedure or surgery | – |
Primary outcome
TRANSVAGINAL ULTRASOUND VERSUS MAGNETIC RESONANCE IMAGING IN DIAGNOSIS OF LAPAROSCOPICALLY MANAGED PATIENTS WITH DEEP INFILTRATING ENDOMETRIOSIS
Time frame: Baseline
The purpose of the study is to compare the reliability and accuracy of systematic ultrasonographic scanning using International Deep Endometriosis Analysis group approach versus magnetic resonance imaging (MRI) assessment in diagnosis of patients with deep infiltrative endometriosis in comparison with intraoperative findings to confirm the diagnosis .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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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.
Tamer Hosny, Ph.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Alexandria 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 4 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: opening soon, as of the sponsor's last update on 12 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rawan El Sawy, Bachelor (01154009283 ext. +20-3, rawanabedmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TRANSVAGINAL ULTRASOUND VERSUS MAGNETIC RESONANCE IMAGING IN DIAGNOSIS OF LAPAROSCOPICALLY MANAGED PATIENTS WITH DEEP INFILTRATING ENDOMETRIOSIS (time frame: Baseline). 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 12 Feb 2025.