Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2018-12-31

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.

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Detailed Description

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Conditions

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Leiomyoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pregnancy expectation

The patients who desire for future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group.

Group Type ACTIVE_COMPARATOR

Interventional radiological or surgical management

Intervention Type PROCEDURE

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.

No pregnancy expectation

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.

Group Type ACTIVE_COMPARATOR

Interventional radiological or surgical management

Intervention Type PROCEDURE

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.

Interventions

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Interventional radiological or surgical management

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.

Intervention Type PROCEDURE

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No