Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma

Sun Yat-sen University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Leiomyoma

Treatments: Procedure: Interventional radiological or surgical management

Study type: Interventional

Funder types: Other

Identifiers

NCT00821275

2007026

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

pregnancy expectation

Active Comparator group

Description:

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

Treatment:

Procedure: Interventional radiological or surgical management

No pregnancy expectation

Active Comparator group

Description:

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.

Treatment:

Procedure: Interventional radiological or surgical management