Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma

January 9, 2009 updated by: Sun Yat-sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

900

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital
      • Guangzhou, Guangdong, China, 510000
        • Nanfang Hospital of Nanfang Medical University
      • Guangzhou, Guangdong, China, 510089
        • The First Affiliated Hospital of Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510630
        • Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: pregnancy expectation
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
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.
ACTIVE_COMPARATOR: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Director: Hong Shan, M.D., PHD., Third Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

January 9, 2009

First Submitted That Met QC Criteria

January 9, 2009

First Posted (ESTIMATE)

January 13, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2009

Last Update Submitted That Met QC Criteria

January 9, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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