Comparing radiofrequency endometrial ablation, uterine artery embolization, and hysterectomy for adenomyosis-related heavy bleeding
Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Women With Adenomyosis-related Abnormal Uterine Bleeding Eligible for Hysterectomy: a Non-inferiority Randomized Clinical Trial Comparing Each Intervention to Hysterectomy
This trial will test whether radiofrequency endometrial ablation or uterine artery embolization can reduce heavy menstrual bleeding, pain, and improve quality of life compared with hysterectomy in people with adenomyosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 30 Years to 50 Years |
| Sex | Female |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 4 sites (Bordeaux and 3 other locations) |
| Trial ID | NCT07195305 on ClinicalTrials.gov |
What this trial studies
This multicenter interventional study enrolls premenopausal women with MRI-confirmed adenomyosis and significant abnormal uterine bleeding who have failed or declined medical therapy. Participants receive one of three procedures—radiofrequency endometrial ablation (RFA), uterine artery embolization (UAE), or hysterectomy—and are followed for outcomes up to two years. Key outcomes include menstrual blood loss (PBAC), pelvic pain, quality of life, procedure-related complications, and recovery metrics. The goal is to compare the effectiveness and safety of uterus-sparing options versus hysterectomy for symptom control.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women aged 30–50 with MRI-confirmed adenomyosis, PBAC >100, uterine size 6–12 cm, and who have failed, cannot take, or refuse medical therapy and are willing to consider hysterectomy or uterus-sparing procedures.
Not a fit: Patients who desire future fertility, have major uterine cavity abnormalities, extensive deep infiltrating endometriosis, or large/multiple fibroids beyond the study criteria are unlikely to benefit from the procedures studied.
Why it matters
Potential benefit: If successful, the study could identify uterus-sparing procedures that control bleeding and pain while avoiding or delaying hysterectomy and shortening recovery time.
How similar studies have performed: UAE has established efficacy for symptomatic fibroids with high satisfaction at two years and RFA has shown modest bleeding and safety benefits in benign AUB, but direct head-to-head comparisons versus hysterectomy specifically for adenomyosis remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 iodine allergy and creatinine clearance \< 60mL/min) * Any contraindication to MRI (claustrophobia, pace maker, etc.) * Any contraindication to the use of Embosphere®, Embozene® or NovaSure® according to the instruction for use * Women who are pregnant, breastfeeding, or who are planning to become pregnant * Any condition or any situation that would prohibit women from coming to the investigational center for the 6 months follow-up * Women unable to understand the nature, risks, significance and implications of the clinical investigation * Women under legal protection
Where this trial is running
Bordeaux and 3 other locations
- CHU Bordeaux — Bordeaux, France (Not_yet_recruiting)
- APHP - Hôpital Antoine Béclère — Clamart, France (Not_yet_recruiting)
- CHU Limoges — Limoges, France (Not_yet_recruiting)
- CHU Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Jean-Luc Brun, MD, PhD
- Email: jean-luc.brun@chu-bordeaux.fr
- Phone: +33 5 56 79 59 85
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.