Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00821275

Enrollment

900

Registered

2009-01-13

Start date

2008-01-31

Completion date

2018-12-31

Last updated

2009-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leiomyoma

Keywords

Uterine Artery Embolization, Leiomyoma, myomectomy, hysterectomy, pregnancy, complication, ovarian function, quality of life

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.

Interventions

PROCEDUREInterventional 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame
quality of life	1,3,5,10 year.
pregnant	3 years

Secondary

Measure	Time frame
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
symptom relief	3,6,12,24 months
complications	3,6,12,24 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026