Randomised trial of gelatin versus embospheres for uterine fibroid embolisation

Uterine artery embolisation for symptomatic fibroids: Comparison of gelatin sponge with embospheres as an embolic agent - a randomised controlled trial (GEM trial)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71074145

Enrollment

200

Registered

2008-09-23

Start date

2010-01-01

Completion date

Unknown

Last updated

2017-10-09

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

Conditions

Uterine fibroids Cancer Leiomyoma of uterus

Interventions

Uterine artery embolisation with either gelatin sponge or Embosphere®. Total duration of follow-up: 12 months

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Patients referred for uterine artery embolisation Added 13/02/2009: 2. Females aged 18 - 55 years

Exclusion criteria

Exclusion criteria: 1. Pregnant 2. Allergy to radiographic contrast media 3. Unable to tolerate magnetic resonance imaging (MRI) scan

Design outcomes

Primary

Measure	Time frame
Degree of fibroid infarction using contrast enhanced MRI, assessed at baseline, 1, 6 and 12 months	—

Secondary

Measure	Time frame
Assessed at baseline, 1, 6 and 12 months: 1. Ovarian function and reserve 2. Quality of life, assessed by Euroqol, Uterine Fibroid Symptom and Quality of Life questionnaire (UFSQoL) 3. Symptom relief, assessed by a linear 11-point score -5 through zero to + 5 4. Reintervention rate	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026