HIFU Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids
ConditionUterine Fibroids (UF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorChinese University of Hong Kong
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- High-Intensity Focused Ultrasound (HIFU)
- myomectomy
Treatment groups
112 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov