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New surgery vs. hormonal IUD: which stops heavy bleeding better?
NCT ID NCT07529587
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new surgical procedure (laparoscopic clipping of certain blood vessels) against a standard hormonal IUD (Mirena) to see which better reduces heavy monthly bleeding in women with enhanced myometrial vascularity. About 56 women aged 18-45 with confirmed diagnosis and symptoms will take part. The goal is to find which treatment works best to control bleeding and improve quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 56 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
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How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
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