Uterine AdenomyosisNCT06652945
Efficacy of Uterine Artery Embolization (UAE) in Management of Symptomatic Uterine Adenomyosis
A study testing Uterine artery embolization in people with Uterine Adenomyosis, run by Assiut University.
Trial summary
Aim of the work: Evaluating the efficiency of uterine artery embolization as a minimally invasive method of treatment in management of symptomatic women with uterine adenomyosis Read more about this study
- Who is it for?
- Ages 35 to 49 years, women only
- Conditions the study is for
- Uterine Adenomyosis
- What is being tested?
- Uterine artery embolization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Mar 2028
- Phase
- Interventional
- 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 35 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women
- Symptomatic pure adenomyosis or dominant adenomyosis when both adenomyosis and fibroids coexist
- Women with an indication for hysterectomy (either failed or refused medical treatment).
Who cannot join
- Patients under 18 years of age,
- Patients with pelvic infection,
- Suspected or confirmed malignancy
- Current or future desire to conceive
- Deep infiltrating endometriosis requiring surgery or obstructing the bowel, or
- Coexisting hysteroscopically removable submucous fibroids
Show all 10Show fewer
- Any absolute contraindication to angiography such as:
- hypersensitivity to intravenous contrast media,
- impaired coagulation profile or
- impaired renal function.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Aim of the work:
Evaluating the efficiency of uterine artery embolization as a minimally invasive method of treatment in management of symptomatic women with uterine adenomyosis
Read the detailed description
Adenomyosis is defined as a non-neoplastic disease, caused by benign invasion of the myometrial layer by endometrial tissue, associated with myometrial smooth muscle hyperplasia. This ectopic endometrium shows two main patterns of distribution in the myometrium: either focal endometrial implant of endometrial glands, or diffuse invasion of the myometrium. Uterine enlargement is often seen with diffuse adenomyosis, while in cases with focal adenomyosis, characteristic feature in ultrasound (US) can be misdiagnosed as leiomyoma, appearing as focal heterogeneous myometrial thickening or myometrial cysts.
Usually, adenomyosis is presented with dysmenorrhea, menorrhagia, and abnormal uterine bleeding. Previously, adenomyosis was diagnosed in multiparous women older than 40 years, causing abnormal uterine bleeding (AUB). But recently, it has been widely recognized among larger group, including nulliparous women earlier in reproductive life, owing to increased availability and better imaging techniques.
The first imaging modality to diagnose adenomyosis is transabdominal sonography (TAS) or transvaginal sonography (TVS). While magnetic resonance (MR) imaging is considered the gold standard diagnosis method due to its accuracy; being noninvasive modality and its ability for better soft tissue characterization to differentiate adenomyosis from other pathologies.
First line of management of adenomyosis include medications as non-steroidal anti-inflammatory drugs and/or hormonal therapy. Yet, other methods of treatment are needed in different cases.
For many years, the most common line of treatment for symptomatic uterine adenomyosis is hysterectomy. Some studies discussed the possibility of uterine-sparing surgeries to treat adenomyosis, despite the controversy of application. Many patients prefer uterine-sparing lines of treatment over hysterectomy, especially after failure of medical treatment. Recent studies have been investigating uterine artery embolization (UAE) as a promising line of treatment of adenomyosis.
In 1995, the study of Ravina was the first to discuss UAE. Ever since, UAE was established as a treatment option for symptomatic patients with adenomyosis, as well as uterine fibroids, owing to its earliest positive results. The objective of UAE is to produce more than 34% necrosis of adenomyotic tissues, using trans-arterial catheters. Recent studies show increasing success rates of managing adenomyosis using UAE, with rates ranging from 60% to 70% and from 72% to 94.3%, respectively.
To evaluate uterine volume and areas of necrosis, patients are referred to perform MRI following the UAE, as in cases with fibroid disease. With regard of different symptoms and presentations of adenomyosis, having a cut-off value to evaluate effectiveness of the procedure to alleviate the symptoms is considered challenging.
Some major complications and side effects can occur such as infections, and pain caused by ischemic necrosis, especially the first hours after the procedure which require strong regimen for pain control. Six percent of the cases complained of persistent amenorrhea, and they were above the age of 40 years old.
- Conditions
- Uterine Adenomyosis
- Being tested
- Uterine artery embolization
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine artery embolizationOther
Also called Fluoroscopy, polyvinyl alcohol (PVA)
Uterine artery embolization under fluoroscopy
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic uterine adenomyosis | Experimental | Patients with symptomatic uterine adenomyosis Receives: Other: Uterine artery embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Management of symptomatic uterine adenomyosis
Relieving the symptoms of uterine adenomyosis using uterine artery embolization such as abnormal uterine bleeding and dysmenorrhea
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine AdenomyosisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohamed Gamal Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652945
- Sponsor's protocol ID
- Uterine Artery Embolization
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Uterine Artery Embolization (UAE) in Management of Symptomatic Uterine Adenomyosis
- ClinicalTrials.gov ID
- NCT06652945
- Acronym / sponsor ID
- Uterine Artery Embolization
- Conditions
- Uterine Adenomyosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 22 Oct 2024 (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.
Aim of the work:
Evaluating the efficiency of uterine artery embolization as a minimally invasive method of treatment in management of symptomatic women with uterine adenomyosis
Detailed description
Adenomyosis is defined as a non-neoplastic disease, caused by benign invasion of the myometrial layer by endometrial tissue, associated with myometrial smooth muscle hyperplasia. This ectopic endometrium shows two main patterns of distribution in the myometrium: either focal endometrial implant of endometrial glands, or diffuse invasion of the myometrium. Uterine enlargement is often seen with diffuse adenomyosis, while in cases with focal adenomyosis, characteristic feature in ultrasound (US) can be misdiagnosed as leiomyoma, appearing as focal heterogeneous myometrial thickening or myometrial cysts.
Usually, adenomyosis is presented with dysmenorrhea, menorrhagia, and abnormal uterine bleeding. Previously, adenomyosis was diagnosed in multiparous women older than 40 years, causing abnormal uterine bleeding (AUB). But recently, it has been widely recognized among larger group, including nulliparous women earlier in reproductive life, owing to increased availability and better imaging techniques.
The first imaging modality to diagnose adenomyosis is transabdominal sonography (TAS) or transvaginal sonography (TVS). While magnetic resonance (MR) imaging is considered the gold standard diagnosis method due to its accuracy; being noninvasive modality and its ability for better soft tissue characterization to differentiate adenomyosis from other pathologies.
First line of management of adenomyosis include medications as non-steroidal anti-inflammatory drugs and/or hormonal therapy. Yet, other methods of treatment are needed in different cases.
For many years, the most common line of treatment for symptomatic uterine adenomyosis is hysterectomy. Some studies discussed the possibility of uterine-sparing surgeries to treat adenomyosis, despite the controversy of application. Many patients prefer uterine-sparing lines of treatment over hysterectomy, especially after failure of medical treatment. Recent studies have been investigating uterine artery embolization (UAE) as a promising line of treatment of adenomyosis.
In 1995, the study of Ravina was the first to discuss UAE. Ever since, UAE was established as a treatment option for symptomatic patients with adenomyosis, as well as uterine fibroids, owing to its earliest positive results. The objective of UAE is to produce more than 34% necrosis of adenomyotic tissues, using trans-arterial catheters. Recent studies show increasing success rates of managing adenomyosis using UAE, with rates ranging from 60% to 70% and from 72% to 94.3%, respectively.
To evaluate uterine volume and areas of necrosis, patients are referred to perform MRI following the UAE, as in cases with fibroid disease. With regard of different symptoms and presentations of adenomyosis, having a cut-off value to evaluate effectiveness of the procedure to alleviate the symptoms is considered challenging.
Some major complications and side effects can occur such as infections, and pain caused by ischemic necrosis, especially the first hours after the procedure which require strong regimen for pain control. Six percent of the cases complained of persistent amenorrhea, and they were above the age of 40 years old.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic uterine adenomyosis | Experimental | Other: Uterine artery embolizationPatients with symptomatic uterine adenomyosis |
Who may qualify
- Ages
- 35 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Premenopausal women
- Symptomatic pure adenomyosis or dominant adenomyosis when both adenomyosis and fibroids coexist
- Women with an indication for hysterectomy (either failed or refused medical treatment).
Key exclusion criteria (10 listed)
- Patients under 18 years of age,
- Patients with pelvic infection,
- Suspected or confirmed malignancy
- Current or future desire to conceive
- Deep infiltrating endometriosis requiring surgery or obstructing the bowel, or
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 |
|---|---|---|
| Uterine artery embolizationAlso: Fluoroscopy, polyvinyl alcohol (PVA)Uterine artery embolization under fluoroscopy | Other | Symptomatic uterine adenomyosis |
Primary outcome
Management of symptomatic uterine adenomyosis
Time frame: three years
Relieving the symptoms of uterine adenomyosis using uterine artery embolization such as abnormal uterine bleeding and dysmenorrhea
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 22 Oct 2024.
- Individual participant dataSharing planned: Yes
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Linzagolix in Adenomyosis and Recurrent Implantation Failure
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine artery embolization in people with Uterine Adenomyosis, run by Assiut University.
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 3 inclusion and 10 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 22 Oct 2024. 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?
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 Sara Mohamed (+201098349966, sara.gamal93@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Management of symptomatic uterine adenomyosis (time frame: three years). 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 22 Oct 2024.