Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Treatment of Adenomyosis-r… (NCT07195305) | Clinical Trial Compass
RecruitingNot Applicable
Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Treatment of Adenomyosis-related Abnormal Uterine Bleeding
France230 participantsStarted 2026-04-17
Plain-language summary
The present study aims to compare the efficacy (menstrual blood loss, pain, quality of life) and the safety (complications, recovery) of each conservative intervention (RFA, UAE) versus hysterectomy for the treatment of adenomyosis-related abnormal uterine bleeding, up to 2 years
Who can participate
Age range
30 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Premenopausal women aged 30 to 50 years
* Women who had at least 3 prior months failed medical therapy, or a contraindication to medical therapy, or refused medical therapy for adenomyosis-related AUB
* Symptomatic pure internal adenomyosis or dominant adenomyosis (with less than 5 concurrent uterine fibroids type 3-7 \< 5 cm) confirmed by MRI (\< 6 months) according to ESHRE criteria
* AUB defined as a PBAC score \>100 at baseline
* Uterine ultrasound measurement of 6.0-12.0 cm (external os to internal fundus)
* Women with an indication for hysterectomy for adenomyosis-related AUB and accepting hysterectomy
* Highly effective contraception for women of childbearing potential, maintained until the onset of menopause
* Affiliated or beneficiary of health insurance
* Signed informed consent
Exclusion Criteria:
* Uterine cavity abnormality or obstruction confirmed via imaging modalities or hysteroscopy
* Deep infiltrating posterior subperitoneal endometriosis involving contiguous digestive tract structures
* Uterine malignancy within the last five years
* Secreting ovarian tumor
* Atypical endometrial hyperplasia
* Unaddressed high grade cervical intra-epithelial lesions
* Active sexually transmitted disease or pelvic inflammatory disease
* Documented or suspected coagulopathies or long-term blood-thinner medications
* Prior transmural myomectomy or prior endometrial ablation
* Plasma FSH level \> 40 IU/mL
* Any contraindication to angiography (including…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
proportion of 2-year clinical success of the intervention