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Compares treatment options for Uterine Fibroids (UF)
Official title HIFU Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids
ClinicalTrials.gov ID: NCT06692335
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- 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
You likely can't join if
- Patient with other pelvic mass indicated by history or magnetic resonance imaging (MRI) such as endometriosis, abnormal adnexal mass, ovarian tumor...
- 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...
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.