Symptomatic uterine fibroids Cancer Leiomyoma of uterus
Conditions
Interventions
Patients referred for routine UAE will be randomised to receive one of two embolic agents. Diffusion weighted MRI and spectroscopy sequences will be carried out at baseline, 24hrs and 6months.
Sponsors
NHS Greater Glasgow and Clyde (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Symptomatic fibroids 2. MRI shows fibroids are greater than 2cm in diameter 3. Willing to be randomised
Exclusion criteria
Exclusion criteria: 1. Severe allergy to radiographic contrast 2. Active infection 3. Contra-indication or unable to tolerate MRI 4. Unable or unwilling to comply with protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diffusion weighted magnetic resonance imaging and spectroscopy of fibroids pre-embolisation and at 24hrs and 6 months post embolisation to detect changes in the fibroid uterus in both arms (Gelfoam and Embospheres) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ovarian function and ovarian follicle reserve at baseline, 24hrs, 1 month and 6 months (Luteinising hormone, Follicle stimulating hormone, Anti-mullerian hormone) 2. Cost-effectiveness comparison Gelfoam, Embospheres | — |
Countries
United Kingdom
Outcome results
None listed