search
Back to results

Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma

Primary Purpose

Leiomyoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Interventional radiological or surgical management
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leiomyoma focused on measuring Uterine Artery Embolization, Leiomyoma, myomectomy, hysterectomy, pregnancy, complication, ovarian function, quality of life

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Nanfang Hospital of Nanfang medical University
  • Guangdong Provincial People's Hospital
  • the first Affiliated Hospital of Sun Yat-sen University
  • Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

pregnancy expectation

No pregnancy expectation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

quality of life
pregnant

Secondary Outcome Measures

tumor recurrence
complications
ovarian functions
symptom relief
tumour volume

Full Information

First Posted
January 9, 2009
Last Updated
January 9, 2009
Sponsor
Sun Yat-sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT00821275
Brief Title
Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma
Official Title
Multi-Center Clinical Trial of Uterine Artery Embolization Treatment of Uterine Leiomyoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma
Keywords
Uterine Artery Embolization, Leiomyoma, myomectomy, hysterectomy, pregnancy, complication, ovarian function, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pregnancy expectation
Arm Type
Active Comparator
Arm Description
The patients who desire for future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group.
Arm Title
No pregnancy expectation
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Interventional radiological or surgical management
Intervention Description
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.
Primary Outcome Measure Information:
Title
quality of life
Time Frame
1,3,5,10 year.
Title
pregnant
Time Frame
3 years
Secondary Outcome Measure Information:
Title
tumor recurrence
Time Frame
1,3,5,10 years
Title
complications
Time Frame
3,6,12,24 months
Title
ovarian functions
Time Frame
3,6,12 months, 2,3,5 and 10 years
Title
symptom relief
Time Frame
3,6,12,24 months
Title
tumour volume
Time Frame
3,6,12 18 24 months and 3,5,10 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Shan, M.D., PHD.
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
Facility Information:
Facility Name
Nanfang Hospital of Nanfang medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
the first Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510089
Country
China
Facility Name
Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.zssy.com.cn/
Description
The Third Affiliated Hospital of Sun Yat-sen University

Learn more about this trial

Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma

We'll reach out to this number within 24 hrs