Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07529587

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Laparoscopic Umbilico-uterine trunk Clipping Approach

Procedure
  • Patient preparation.
  • Laparoscopic technique.
  • Identification and clipping of the umbilico-uterine trunk.
  • Post-operative care.

Mirena Intrauterine Device Insertion

Procedure

Mirena Intrauterine Device Insertion is considered the current standard of care or a relevant alternative

Primary outcomes

  1. monthly menstrual blood loss

    Time frame: The change in PBAC score within 6 months after procedure

    The change in PBAC score

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.