Comparing HIFU and myomectomy for treating uterine fibroids

A Randomized Controlled Trial of High-Intensity Focused Ultrasound (HIFU) Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids

This study is testing whether High-Intensity Focused Ultrasound (HIFU) is a better option than surgery for treating painful uterine fibroids in women aged 18 to 50.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Chinese University of Hong Kong (other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT06692335 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 50 with symptomatic uterine fibroids causing menorrhagia, pressure, or pelvic pain.

Not a fit: Patients with other pelvic masses, morbid obesity, or uterine malignancies will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for women suffering from symptomatic uterine fibroids.

How similar studies have performed: Other studies have shown promising results with HIFU for uterine fibroids, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Hong Kong

• 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

Conditions: Uterine Fibroids, symptomatic uterine fibroid, Menorrhagia, Dysmenorrhea