Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT07195305
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
50 Years
Study:
NCT07195305
Study Brief:
Protocol Section:
NCT07195305