NCT07195305 Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Treatment of Adenomyosis-related Abnormal Uterine Bleeding
| NCT ID | NCT07195305 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Abnormal Uterine Bleeding Due to Adenomyosis (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2026-04-17 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 230 participants in total. It began in 2026-04-17 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 for the treatment of adenomyosis-related abnormal uterine bleeding, up to 2 years
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07195305 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 50 Years, studying Abnormal Uterine Bleeding Due to Adenomyosis (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07195305 currently recruiting?
Yes, NCT07195305 is actively recruiting participants. Contact the research team at jean-luc.brun@chu-bordeaux.fr for enrollment information.
Where is the NCT07195305 trial being conducted?
This trial is being conducted at Bordeaux, France, Clamart, France, Limoges, France, Montpellier, France.
Who is sponsoring the NCT07195305 clinical trial?
NCT07195305 is sponsored by University Hospital, Bordeaux. The trial plans to enroll 230 participants.