RecruitingNot ApplicableNCT06692335

HIFU Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids

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


Sponsor

Chinese University of Hong Kong

Enrollment

112 participants

Start Date

Feb 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if High-Intensity Focused Ultrasound (HIFU) is as effective as myomectomy for treating symptomatic uterine fibroids in women aged 18 to 50. The main questions it aims to answer are: Is HIFU as effective as myomectomy in improving quality of life for women with uterine fibroids? How do the recovery times and complications compare between HIFU and myomectomy? Researchers will compare the outcomes of women receiving HIFU treatment to those undergoing myomectomy to see if HIFU offers similar or better results with fewer complications. Participants will: Undergo an initial medical assessment, including ultrasounds and blood tests. Receive either HIFU treatment or myomectomy based on random assignment. Complete questionnaires about their symptoms and quality of life before treatment and at follow-up visits (3 and 6 months post-treatment). Be monitored for any complications and recovery progress during follow-up.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for uterine fibroids — non-cancerous growths in the uterus that can cause heavy bleeding and pelvic pain. It compares high-intensity focused ultrasound (HIFU), a non-surgical procedure that uses sound waves to shrink fibroids, with the standard surgical removal (myomectomy). **You may be eligible if...** - You are between 18 and 50 years old - You are pre- or peri-menopausal with normal hormone levels - You have a uterine fibroid between 3 and 10 cm causing symptoms like heavy periods, pressure, or pelvic pain - Your uterus is not enlarged beyond 18 weeks of pregnancy size - Your BMI is below 33 or your abdominal wall is less than 5 cm thick **You may NOT be eligible if...** - You have endometriosis, ovarian cysts, or other pelvic conditions - You are severely obese or cannot lie face-down for more than 2 hours - You have large, rapid-growing, or unusually positioned fibroids - You are pregnant, breastfeeding, or menopausal - You have a blood clotting disorder or history of blood clots or stroke - You have had previous pelvic radiation therapy - You cannot have an MRI scan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHigh-Intensity Focused Ultrasound (HIFU)

The HIFU treatment will utilize the Haifu JC 200 system under real-time ultrasound guidance, with participants positioned prone in a water-filled generator chamber. Conscious sedation will be administered using fentanyl and midazolam, adjusted based on pain tolerance. Acoustic output power will range from 300 to 400W.

PROCEDUREmyomectomy

Laparoscopic or open or hysteroscopic myomectomy will be performed.


Locations(1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

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NCT06692335


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