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
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Condition or disease | Intervention/treatment | Phase |
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Leiomyoma | Procedure: Interventional radiological or surgical management | Phase 2 Phase 3 |
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 |
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.
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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.
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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. |
- quality of life [ Time Frame: 1,3,5,10 year. ]
- pregnant [ Time Frame: 3 years ]
- tumor recurrence [ Time Frame: 1,3,5,10 years ]
- complications [ Time Frame: 3,6,12,24 months ]
- ovarian functions [ Time Frame: 3,6,12 months, 2,3,5 and 10 years ]
- symptom relief [ Time Frame: 3,6,12,24 months ]
- tumour volume [ Time Frame: 3,6,12 18 24 months and 3,5,10 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

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
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 |
Study Director: | Hong Shan, M.D., PHD. | Third Affiliated Hospital, Sun Yat-Sen University |
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 |
Uterine Artery Embolization Leiomyoma myomectomy hysterectomy |
pregnancy complication ovarian function quality of life |
Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases |