NCT06692335 HIFU Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids
| NCT ID | NCT06692335 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Uterine Fibroids (UF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2025-02-06 |
| Primary Completion | 2027-06-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 112 participants in total. It began in 2025-02-06 with a primary completion date of 2027-06-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Shing Chee Chan
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06692335 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Uterine Fibroids (UF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06692335 currently recruiting?
Yes, NCT06692335 is actively recruiting participants. Contact the research team at symphorosa@cuhk.edu.hk for enrollment information.
Where is the NCT06692335 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06692335 clinical trial?
NCT06692335 is sponsored by Chinese University of Hong Kong. The principal investigator is Shing Chee Chan at Chinese University of Hong Kong. The trial plans to enroll 112 participants.