Actively Recruiting
A Randomized Controlled Trial Comparing High-Intensity Focused Ultrasound (HIFU) Versus Myomectomy for Symptomatic Uterine Fibroids
Led by Chinese University of Hong Kong · Updated on 2026-03-27
112
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing High-Intensity Focused Ultrasound (HIFU) to myomectomy surgery to treat symptomatic uterine fibroids in women aged 18 to 50. This randomized controlled trial aims to see if HIFU improves quality of life as well as myomectomy while potentially offering shorter recovery and fewer complications. The study follows strict clinical and ethical guidelines to ensure thorough evaluation of both treatments.
CONDITIONS
Brief Title
HIFU Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 50 years
- Pre or peri menopausal with FSH less than 25 mIU/ml
- Body mass index less than 33 kg/m2 or abdominal wall thickness less than 5 cm
- Uterine size 18 weeks or less based on physical exam
- Dominant intramural fibroid measuring between 3 cm and 10 cm on imaging
- Symptomatic fibroids causing heavy menstrual bleeding, pressure, or pelvic pain
- Willing and able to provide informed consent
You will not qualify if you...
- Presence of other pelvic masses such as endometriosis, abnormal adnexal mass, ovarian tumor, or pelvic inflammatory disease
- Morbid obesity
- Unable to lie prone for more than 2 hours
- Extensive abdominal scar in the area for ultrasound treatment
- Pregnancy, lactation, or menopause
- Uterine premalignant or malignant conditions or uncertain diagnosis excluding fibroids
- Rapid fibroid growth doubling in size within 6 months
- History or current thromboembolic events such as deep vein thrombosis or stroke
- Coagulation problems or use of blood-thinning medications
- History of pelvic radiation therapy
- Large pedunculated submucosal or subserosal fibroid over 5 cm with small stalk
- Cervical or broad ligament fibroids
- Contraindication to MRI due to claustrophobia or metallic implants
- Co-existing adenomyosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Treatment and immediate post-procedure care occur on the day of intervention; hospital stay for myomectomy ranges from same day to up to 3 days
Participants receive either High-Intensity Focused Ultrasound (HIFU) treatment or undergo myomectomy surgery to treat symptomatic uterine fibroids. The HIFU procedure includes pelvic MRI for treatment planning, conscious sedation, and monitoring for 4 to 6 hours post-treatment. Myomectomy may be laparoscopic, open, or hysteroscopic with postoperative monitoring and blood tests approximately 6 hours after surgery.
1 treatment visit with post-procedure observation; hospital stay varies depending on surgical technique
Duration - 6 months
Participants are followed up to monitor recovery and treatment outcomes. This includes a telephone interview at 2 weeks, and face-to-face assessments at 3 months and 6 months post-treatment, during which questionnaires, physical exams, and ultrasound scans are performed.
1 telephone visit at 2 weeks and 2 in-person visits at 3 and 6 months
Trial Site Locations
Total: 1 location
1
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
Research Team
S
Shing Chee Chan
L
LAI LOI LEE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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