本临床试验的目的是了解高强度聚焦超声（HIFU）治疗18至50岁女性症状性子宫肌瘤是否与子宫肌瘤切除术同样有效。其主要探讨的问题包括： HIFU在改善子宫肌瘤女性生活质量方面是否与子宫肌瘤切除术同样有效？HIFU与子宫肌瘤切除术的恢复时间及并发症如何比较？
适应症：Uterine Fibroids (UF)
入组条件
纳入标准
- Age 18 - 50 years-old
- Pre or peri menopausal with FSH less than 25 mIU/ml
- BMI \< 33 kg/m2 or abdominal wall thickness \< 5 cm
- Uterine size ≤18 weeks based on physical exam assessment
- Dominant intramural fibroid ≥ 3cm and ≤ 10cm on imaging
- Symptomatic fibroids cause menorrhagia, pressure, or pelvic pain
- Willing and able to give informed consent
排除标准
- Patient with other pelvic mass indicated by history or magnetic resonance imaging (MRI) such as endometriosis, abnormal adnexal mass, ovarian tumor, acute or chronic pelvic inflammatory disease
- Morbid obesity
- Inability to lie in a prone position for more than 2 hours
- Extensive abdominal scar on the acoustic channel
- Women with pregnancy, lactation or menopause
- Uterine premalignant or malignant pathologies or pathology other than uterine fibroid cannot be ruled out through detailed clinical assessment and investigation including MRI
- Rapid growth of fibroids, defined as a doubling in size in 6 months
- History of or current thromboembolic event (deep vein thrombosis, pulmonary embolus, stroke)
- Coagulation problem or using medication which affect clotting function
- History of pelvic irradiation
- Pedunculated submucosal or subserosal fibroid of size ≧5cm and with a stalk less than 25% of the maximal fibroid diameter
- Cervical/ broad ligament fibroid
- Contraindication to MRI due to severe claustrophobia or implanted metallic device.
- Co-existing adenomyosis
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。