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RECRUITING
NCT06692335
NA

HIFU Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2025-02-06

Completion Date

2027-12-31

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

PROCEDURE

High-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.

PROCEDURE

myomectomy

Laparoscopic or open or hysteroscopic myomectomy will be performed.

Locations (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong