Enhanced Myometrial VascularityNCT07529587
Laparoscopic Umbilico-uterine Trunk Clipping Approach in the Management of Enhanced Myometrial Vascularity
A study testing Laparoscopic Umbilico-uterine trunk Clipping Approach and Mirena Intrauterine Device Insertion in people with Enhanced Myometrial Vascularity, run by Minia University.
Trial summary
This study aims to address this knowledge gap by conducting a randomized active-controlled trial comparing laparoscopic umbilico-uterine trunk clipping with Mirena Intrauterine Device Insertion (an active treatment method chosen and justified based on current clinical practice) in reducing monthly menstrual blood loss… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Enhanced Myometrial Vascularity
- What is being tested?
- Laparoscopic Umbilico-uterine trunk Clipping Approach and Mirena Intrauterine Device Insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2026to 10 Apr 2027
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed diagnosis of Enhanced Myometrial Vascularity.
- Presence of clinical symptoms related to Enhanced Myometrial Vascularity: Such as menorrhagia affecting quality of life, or abnormal uterine bleeding (AUB) unresponsive to initial medical treatments.
- Women of reproductive age (18-45 years).
- Willingness to undergo surgical treatment: Participants must be willing to undergo one of the two surgical procedures under investigation (laparoscopic umbilico-uterine trunk clipping or Mirena Intrauterine Device Insertion).
- Written informed consent: Participants must be able to understand the study information and provide written informed consent to participate.
- Adequate general health to undergo anesthesia and laparoscopic surgery: This will be assessed by the responsible physician
Who cannot join
- Presence of other known causes of menorrhagia or abnormal uterine bleeding: Such as large uterine fibroids (> 3 cm in diameter, or with a location causing distortion of the uterine cavity), large endometrial polyps, untreated endometrial hyperplasia, or known bleeding disorders.
- History of extensive prior pelvic surgery: That may increase the difficulty or risks of laparoscopic surgery or significantly affect uterine blood supply.
- Current pregnancy or suspicion of pregnancy: Pregnancy testing will be performed before enrollment.
- Current breastfeeding.
- Presence of contraindications to general anesthesia or laparoscopic surgery: This will be assessed by the anesthesiologist.
- Severe, unstable systemic diseases: Such as uncontrolled cardiovascular disease, pulmonary disease, renal disease, or liver disease.
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- Receiving hormonal therapy that affects the menstrual cycle or uterine blood flow.
- Participation in another clinical trial that could interfere with the outcomes of this study.
- Inability to comply with study procedures or follow-up.
- Any other condition that the principal investigator deems would compromise the safety of the participant or affect the study outcomes.
About this study
This study aims to address this knowledge gap by conducting a randomized active-controlled trial comparing laparoscopic umbilico-uterine trunk clipping with Mirena Intrauterine Device Insertion (an active treatment method chosen and justified based on current clinical practice) in reducing monthly menstrual blood loss in women with enhanced myometrial vascularity. By providing reliable data on clinical efficacy and patient-related outcomes, this study can contribute to guiding clinical decision-making and improving the care of women with this condition.
- Conditions
- Enhanced Myometrial Vascularity
- Being tested
- Laparoscopic Umbilico-uterine trunk Clipping Approach, Mirena Intrauterine Device Insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Umbilico-uterine trunk Clipping ApproachProcedure or surgery
- Patient preparation.
- Laparoscopic technique.
- Identification and clipping of the umbilico-uterine trunk.
- Post-operative care.
Mirena Intrauterine Device InsertionProcedure or surgery
Mirena Intrauterine Device Insertion is considered the current standard of care or a relevant alternative
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Umbilico-uterine trunk Clipping Approach | Experimental | Not described Receives: Procedure: Laparoscopic Umbilico-uterine trunk Clipping Approach |
| Mirena Intrauterine Device Insertion | Active comparator | Not described Receives: Procedure: Mirena Intrauterine Device Insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
monthly menstrual blood loss
The change in PBAC score
Measured: The change in PBAC score within 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Myometrial VascularityStudies of the same condition, open and under way.
- More trials run by Minia 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hassan Mohamed Abdel Ghfar, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529587
- Sponsor's protocol ID
- 1647-8-2025
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 14 Apr 2026
- 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Umbilico-uterine Trunk Clipping Approach in the Management of Enhanced Myometrial Vascularity
- ClinicalTrials.gov ID
- NCT07529587
- Acronym / sponsor ID
- 1647-8-2025
- Conditions
- Enhanced Myometrial Vascularity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 14 Apr 2026 (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.
This study aims to address this knowledge gap by conducting a randomized active-controlled trial comparing laparoscopic umbilico-uterine trunk clipping with Mirena Intrauterine Device Insertion (an active treatment method chosen and justified based on current clinical practice) in reducing monthly menstrual blood loss in women with enhanced myometrial vascularity. By providing reliable data on clinical efficacy and patient-related outcomes, this study can contribute to guiding clinical decision-making and improving the care of women with this condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Umbilico-uterine trunk Clipping Approach | Experimental | Procedure: Laparoscopic Umbilico-uterine trunk Clipping Approach |
| Mirena Intrauterine Device Insertion | Active comparator | Procedure: Mirena Intrauterine Device Insertion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of Enhanced Myometrial Vascularity.
- Presence of clinical symptoms related to Enhanced Myometrial Vascularity: Such as menorrhagia affecting quality of life, or abnormal uterine bleeding (AUB) unresponsive to initial medical treatments.
- Women of reproductive age (18-45 years).
- Willingness to undergo surgical treatment: Participants must be willing to undergo one of the two surgical procedures under investigation (laparoscopic umbilico-uterine trunk clipping or Mirena Intrauterine Device Insertion).
- Written informed consent: Participants must be able to understand the study information and provide written informed consent to participate.
Key exclusion criteria (10 listed)
- Presence of other known causes of menorrhagia or abnormal uterine bleeding: Such as large uterine fibroids (> 3 cm in diameter, or with a location causing distortion of the uterine cavity), large endometrial polyps, untreated endometrial hyperplasia, or known bleeding disorders.
- History of extensive prior pelvic surgery: That may increase the difficulty or risks of laparoscopic surgery or significantly affect uterine blood supply.
- Current pregnancy or suspicion of pregnancy: Pregnancy testing will be performed before enrollment.
- Current breastfeeding.
- Presence of contraindications to general anesthesia or laparoscopic surgery: This will be assessed by the anesthesiologist.
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 |
|---|---|---|
| Laparoscopic Umbilico-uterine trunk Clipping Approach1. Patient preparation. 2. Laparoscopic technique. 3. Identification and clipping of the umbilico-uterine trunk. 4. Post-operative care. | Procedure or surgery | Laparoscopic Umbilico-uterine trunk Clipping Approach |
| Mirena Intrauterine Device InsertionMirena Intrauterine Device Insertion is considered the current standard of care or a relevant alternative | Procedure or surgery | Mirena Intrauterine Device Insertion |
Primary outcome
monthly menstrual blood loss
Time frame: The change in PBAC score within 6 months after procedure
The change in PBAC score
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 14 Apr 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Umbilico-uterine trunk Clipping Approach and Mirena Intrauterine Device Insertion in people with Enhanced Myometrial Vascularity, run by Minia 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 6 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 14 Apr 2026. 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?
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?
monthly menstrual blood loss (time frame: The change in PBAC score within 6 months after procedure). 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 14 Apr 2026.