Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma

Phase 2

• Conditions: Leiomyoma
• Interventions: Procedure: Interventional radiological or surgical management

• Registration Number: NCT00821275
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Status Verified: 2009-01
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-09
• Last Update Submitted: 2009-01-09
• Study First Posted: 2009-01-13
• Last Update Posted: 2009-01-13
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 900

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pregnancy expectation	Interventional radiological or surgical management	The patients who desire for future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group.
No pregnancy expectation	Interventional radiological or surgical management	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.

Primary Outcome Measures

Name	Time	Method
quality of life	1,3,5,10 year.
pregnant	3 years

Secondary Outcome Measures

Name	Time	Method
complications	3,6,12,24 months
symptom relief	3,6,12,24 months
ovarian functions	3,6,12 months, 2,3,5 and 10 years
tumor recurrence	1,3,5,10 years
tumour volume	3,6,12 18 24 months and 3,5,10 years

Trial Locations

Locations (4)

the first Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Nanfang Hospital of Nanfang medical University; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China