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New surgery vs. hormonal IUD: which stops heavy bleeding better?

NCT ID NCT07529587

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 45 years

Sex

Female participants only

Healthy volunteers

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

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

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  1. The official record

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