Actively Recruiting
Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Treatment of Adenomyosis-related Abnormal Uterine Bleeding
Led by University Hospital, Bordeaux · Updated on 2026-04-20
230
Participants Needed
4
Research Sites
158 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Bordeaux
Lead Sponsor
F
French Ministry of Social Affairs and Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Treatment of Adenomyosis-related Abnormal Uterine Bleeding
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premenopausal women aged 30 to 50 years
- At least 3 months of failed medical therapy, contraindication to medical therapy, or refusal of medical therapy for adenomyosis-related abnormal uterine bleeding
- Symptomatic pure internal adenomyosis or dominant adenomyosis with fewer than 5 uterine fibroids (type 3-7, less than 5 cm), confirmed by MRI within 6 months according to ESHRE criteria
- Abnormal uterine bleeding defined as a PBAC score greater than 100 at baseline
- Uterine size between 6.0 and 12.0 cm measured by ultrasound
- Indication for hysterectomy for adenomyosis-related abnormal uterine bleeding and acceptance of hysterectomy
- Use of highly effective contraception for women of childbearing potential until menopause
- Affiliated or beneficiary of health insurance
- Signed informed consent
You will not qualify if you...
- Uterine cavity abnormality or obstruction confirmed by imaging or hysteroscopy
- Deep infiltrating posterior subperitoneal endometriosis involving 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 use
- Prior transmural myomectomy or prior endometrial ablation
- Plasma FSH level above 40 IU/mL
- Contraindication to angiography including iodine allergy or low creatinine clearance
- Contraindication to MRI such as claustrophobia or pacemaker
- Contraindications to use of Embosphere®, Embozene®, or NovaSure®
- Pregnancy, breastfeeding, or planning pregnancy
- Any condition preventing attendance at 6-month follow-up
- Inability to understand the study risks and implications
- Women under legal protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
CHU Bordeaux
Bordeaux, France
Not Yet Recruiting
2
APHP - Hôpital Antoine Béclère
Clamart, France, 92140
Not Yet Recruiting
3
CHU Limoges
Limoges, France, 87042
Not Yet Recruiting
4
CHU Montpellier
Montpellier, France, 34090
Actively Recruiting
Research Team
J
Jean-Luc Brun, MD, PhD
CONTACT
M
Marc Sapoval, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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