Comparing HIFU and myomectomy for treating uterine fibroids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of High-Intensity Focused Ultrasound (HIFU) compared to myomectomy in women aged 18 to 50 with symptomatic uterine fibroids. Participants will be randomly assigned to receive either HIFU treatment or myomectomy after thorough medical assessments, including ultrasounds and blood tests. The study will measure outcomes related to quality of life, recovery times, and complications through questionnaires and follow-up visits at 3 and 6 months post-treatment. The trial adheres to international clinical practice guidelines to ensure rigorous methodology.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• The Chinese University of Hong Kong
  Hong Kong, Hong Kong Recruiting

Study contacts

• Principal investigator: Shing Chee Chan — Chinese University of Hong Kong
• Study coordinator: Shing Chee Chan
• Email: symphorosa@cuhk.edu.hk
• Phone: 852-35052803

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.