RecruitingNAINTERVENTIONAL

Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Treatment of Adenomyosis-related Abnormal Uterine Bleeding

This study is looking into the best ways to help women who have heavy and painful periods because of a condition called adenomyosis. Adenomyosis happens when the lining of the womb grows into its muscular wall. The study compares two treatments that don't involve removing the womb: radiofrequency endometrial ablation (which uses heat to remove the womb lining) and uterine artery embolization (which blocks blood flow to the womb). These are being compared with a hysterectomy (removing the womb). Researchers want to see which treatment works best to reduce heavy bleeding and pain, improves quality of life, and what side effects or recovery times are involved. This comparison will help understand the long-term effects over two years.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Bordeaux

Enrolment target

230

Start

17 Apr 2026

Estimated completion

01 May 2029

Abnormal Uterine Bleeding Due to Adenomyosis (Disorder)

What is this study about?

Imagine your womb has a special lining that usually sheds during your period. With adenomyosis, some of this lining grows into the muscle wall of your womb. This can make your periods very heavy and painful. Many women develop this condition, especially as they get older.

When standard medicines don't help enough, doctors might suggest a hysterectomy, which is an operation to remove the womb. However, some women might not want to have a hysterectomy, especially if they wish to keep their womb. This study is exploring two other options that are less invasive than a hysterectomy: one uses heat to treat the womb lining (radiofrequency ablation), and the other blocks blood vessels to reduce blood flow to the womb (uterine artery embolization). Both are already used for similar conditions and are often done as day procedures or with a very short hospital stay.

This research aims to understand how well these less invasive treatments work compared to a hysterectomy, for up to two years. They will look at whether these treatments successfully reduce heavy bleeding and pain, how they affect a woman's daily life, and any problems or how long it takes to recover from them. The goal is to provide clearer information for women and doctors about the different choices available for managing adenomyosis.

Key takeaways

The study compares hysterectomy with two less-invasive adenomyosis treatments.
It focuses on reducing heavy bleeding and pain.
Quality of life and safety are also key measures.
Participants will be followed for up to two years.
The goal is to find better treatment options for adenomyosis.

Who may be eligible?

This study is looking for women between 30 and 50 years old who are still having periods. You might be suitable if you have heavy periods caused by adenomyosis, which has been confirmed by a scan like an MRI, and if other treatments haven't worked or aren't suitable for you. Your womb size must also be within a specific range.

It's important that you are not planning to get pregnant and are using effective contraception. You should also be prepared for a hysterectomy if that's the treatment you end up having as part of the study, and be able to attend follow-up appointments for six months.

However, you won't be able to join if you have certain other conditions, such as problems with the inside of your womb, certain types of endometriosis or cancer, active infections, or if you're pregnant or breastfeeding. Also, if you have allergies to certain medical products or conditions that make MRI scans or specific procedures unsafe, you won't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman between 30 and 50 years old?
Do you have heavy periods due to adenomyosis, confirmed by a scan?
Have other treatments for your periods not worked for at least 3 months?
Are you not planning to get pregnant and using effective contraception?
Are you prepared to potentially have a hysterectomy if assigned to that group?

Answer every question to see your result.

What does participation involve?

If you join this study, your treatment will be one of three options: Radiofrequency endometrial ablation, Uterine artery embolization, or a Hysterectomy. You will continue to have regular check-ups to see how well the treatment is working and to monitor for any side effects. This includes visits to the clinic and possibly scans. Researchers will be looking at how your periods change, if your pain improves, and how your overall quality of life is affected. The study will follow you for up to two years to understand the long-term effects of the treatment you receive.

Potential risks and benefits

Taking part could offer the benefit of receiving a treatment for your adenomyosis-related heavy bleeding and pain, which might improve your quality of life. The study helps doctors learn which treatments work best and are safest. However, like any medical procedure, there are potential risks, such as pain, infection, or other complications, depending on the treatment you receive. You will be fully informed about these before you decide to take part. Remember, you can withdraw from the study at any time without it affecting your usual medical care.

Locations (4)

CHU Bordeaux
Verified postcode
Bordeaux, France· Not yet recruiting
APHP - Hôpital Antoine Béclère
Verified postcode
Clamart, France· Not yet recruiting
CHU Limoges
Verified postcode
Limoges, France· Not yet recruiting
CHU Montpellier
Verified postcode
Montpellier, France· Recruiting

Common questions

What is adenomyosis?

It's a condition where the womb's lining grows into its muscular wall, often causing heavy, painful periods.

What are the treatments being compared?

Two less invasive options (radiofrequency ablation and uterine artery embolization) are compared to a hysterectomy (womb removal).

How long will I be followed in the study?

You will be followed for up to two years to track how well the treatment works and your recovery.

Are these treatments new?

The treatments themselves are used for similar conditions, but this study is comparing their effectiveness directly for adenomyosis.

Can I get pregnant after these treatments?

This study is for women who are not planning to get pregnant and are using effective contraception, as some treatments might affect fertility or are not suitable for future pregnancies.

How to find out more

Jean-Luc Brun, MD, PhD

jean-luc.brun@chu-bordeaux.fr +33 5 56 79 59 85 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.