Status:
NOT_YET_RECRUITING
Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Treatment of Adenomyosis-related Abnormal Uterine Bleeding
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
French Ministry of Social Affairs and Health
Conditions:
Abnormal Uterine Bleeding Due to Adenomyosis (Disorder)
Eligibility:
FEMALE
30-50 years
Phase:
NA
Brief 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 f...
Detailed Description
Adenomyosis is defined by the presence of ectopic non-atypical endometrial glands and stroma within the smooth muscle fibers of the myometrium causing reactive hypertrophy of the uterus. The prevalenc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT07195305
Start Date
January 1 2026
End Date
May 1 2029
Last Update
January 5 2026
Active Locations (1)
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1
CHU Bordeaux
Bordeaux, France