Laparoscopic Umbilico-uterine Trunk Clipping Approach in the Management of Enhanced Myometrial Vascularity

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 Overview

• Status: Not yet recruiting
• Conditions: Enhanced Myometrial Vascularity
• Intervention / Treatment: Procedure: Laparoscopic Umbilico-uterine trunk Clipping Approach; Procedure: Mirena Intrauterine Device Insertion

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Confirmed diagnosis of Enhanced Myometrial Vascularity.
2. 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.
3. Women of reproductive age (18-45 years).
4. 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).
5. Written informed consent: Participants must be able to understand the study information and provide written informed consent to participate.
6. Adequate general health to undergo anesthesia and laparoscopic surgery: This will be assessed by the responsible physician

Exclusion Criteria:

1. 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.
2. History of extensive prior pelvic surgery: That may increase the difficulty or risks of laparoscopic surgery or significantly affect uterine blood supply.
3. Current pregnancy or suspicion of pregnancy: Pregnancy testing will be performed before enrollment.
4. Current breastfeeding.
5. Presence of contraindications to general anesthesia or laparoscopic surgery: This will be assessed by the anesthesiologist.
6. Severe, unstable systemic diseases: Such as uncontrolled cardiovascular disease, pulmonary disease, renal disease, or liver disease.
7. Receiving hormonal therapy that affects the menstrual cycle or uterine blood flow.
8. Participation in another clinical trial that could interfere with the outcomes of this study.
9. Inability to comply with study procedures or follow-up.
10. Any other condition that the principal investigator deems would compromise the safety of the participant or affect the study outcomes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic Umbilico-uterine trunk Clipping Approach	Procedure: Laparoscopic Umbilico-uterine trunk Clipping Approach; Patient preparation.; Laparoscopic technique.; Identification and clipping of the umbilico-uterine trunk.; Post-operative care.
Active Comparator: Mirena Intrauterine Device Insertion	Procedure: Mirena Intrauterine Device Insertion; Mirena Intrauterine Device Insertion is considered the current standard of care or a relevant alternative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
monthly menstrual blood loss	The change in PBAC score	The change in PBAC score within 6 months after procedure

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2026
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): April 10, 2027

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1647-8-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No