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Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma

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ClinicalTrials.gov Identifier: NCT00821275
Recruitment Status : Unknown
Verified January 2009 by Sun Yat-sen University.
Recruitment status was:  Enrolling by invitation
First Posted : January 13, 2009
Last Update Posted : January 13, 2009
Sponsor:
Information provided by:
Sun Yat-sen University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Leiomyoma Procedure: Interventional radiological or surgical management Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Center Clinical Trial of Uterine Artery Embolization Treatment of Uterine Leiomyoma
Study Start Date : January 2008
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. quality of life [ Time Frame: 1,3,5,10 year. ]
  2. pregnant [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. tumor recurrence [ Time Frame: 1,3,5,10 years ]
  2. complications [ Time Frame: 3,6,12,24 months ]
  3. ovarian functions [ Time Frame: 3,6,12 months, 2,3,5 and 10 years ]
  4. symptom relief [ Time Frame: 3,6,12,24 months ]
  5. tumour volume [ Time Frame: 3,6,12 18 24 months and 3,5,10 years ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821275


Locations
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China, Guangdong
Nanfang Hospital of Nanfang medical University
Guangzhou, Guangdong, China, 510000
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
the first Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510089
Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Director: Hong Shan, M.D., PHD. Third Affiliated Hospital, Sun Yat-Sen University
More Information
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Responsible Party: Hong Shan, the third Affiliated Hospital of Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00821275    
Other Study ID Numbers: 2007026
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: January 13, 2009
Last Verified: January 2009
Keywords provided by Sun Yat-sen University:
Uterine Artery Embolization
Leiomyoma
myomectomy
hysterectomy
 pregnancy
complication
ovarian function
quality of life
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases