Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma

Study Overview
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Brief Summary
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The efficacy and safety of uterine artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. The purpose of this trial is to evaluate the uterine volume and tumor size reduction, symptomatic relief, complication, fertility, ovarian function and quality of life with uterine artery embolization for uterine fibroids comparing with standard surgical methods.

Official Title
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Multi-Center Clinical Trial of Uterine Artery Embolization Treatment of Uterine Leiomyoma

Conditions
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Leiomyoma

Intervention / Treatment
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* Procedure: Interventional radiological or surgical management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of symptomatic uterine leiomyoma Exclusion Criteria: pregnancy iodine agent allergy patient refuse to take part in this trial tumour size is less than 3cm or beyond 10cm with endometriosis with malignant diseases with abnormal coagulation function which can't restore with acute inflammatory diseases or acute episode of chronic inflammatory diseases with severe heart, lung, liver and kidney, et al. organ diseases.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pregnancy expectation<br>The patients who desire for future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group. | Procedure: Interventional radiological or surgical management<br>* Uterine artery embolization will be done for the patients who enroll into UAE group and desire for future pregancy and reserving uterus.Myomectomy will be performed for the patients who enroll into SURGERY group and desire for future pregancy and reserving uterus.Hysterectomy will be done for the patients who enroll into SURGERY group and don't desire for reserving uterus and/or future pregnancy.<br>|
| Active Comparator: No pregnancy expectation<br>The patients who don't desire for reserving uterus and/ or future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group. | Procedure: Interventional radiological or surgical management<br>* Uterine artery embolization will be done for the patients who enroll into UAE group and desire for future pregancy and reserving uterus.Myomectomy will be performed for the patients who enroll into SURGERY group and desire for future pregancy and reserving uterus.Hysterectomy will be done for the patients who enroll into SURGERY group and don't desire for reserving uterus and/or future pregnancy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | 1,3,5,10 year. | 
| pregnant |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor recurrence |  | 1,3,5,10 years | 
| complications |  | 3,6,12,24 months | 
| ovarian functions |  | 3,6,12 months, 2,3,5 and 10 years | 
| symptom relief |  | 3,6,12,24 months | 
| tumour volume |  | 3,6,12 18 24 months and 3,5,10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine Artery Embolization, Leiomyoma, myomectomy, hysterectomy, pregnancy, complication, ovarian function, quality of life