Clinical trial · Interventional
Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids
NCT02577055CI-TRIAL-00097606Lune2completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Purpose of this study: To establish the superiority of myomectomy versus Uterine Artery Embolization, in women with multiple symptomatic fibroids and no other infertility factor, seeking to conceive.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| embolisation | Procedure | — | UNRESOLVED |
| myomectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- myomectomy
- description
- Women will be treated with surgical removal of all fibroids, either by laparoscopic or abdominal route
- interventionNames
- Procedure: myomectomy
- type
- EXPERIMENTAL
- label
- embolisation
- description
- Women will be treated with fertility sparing uterine arteries embolization (i..e. with ultra thin catheter, and particles' diameter \> 500µm)
- interventionNames
- Procedure: embolisation
Primary outcomes (1)
- measure
- Number of live birth in a year of fertility attempt
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 43 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged ≥ 18 and ≤ 43 years old * At least one interstitial fibroid more than 3 cm on MRIat MRI) * with symptoms: genital bleeding, chronic pelvic pain or heaviness, anemia, or infertility \> 1 year. * With immediate desire to conceive * without assisted reproductive indication: no tubal infertility, menstrual irregularities, hydrosalpinx, endometriosis, adenomyosis, or male infertility. * Patient with health insurance, who can read and understand French and who has given written consent Exclusion Criteria: * Ongoing regnancy * Emergency Situation * Contraindication to surgery or uterine embolization: allergy to contrast medium , renal failure, immunodeficiency, contraindication to anesthesia, subserosal or submucosal pedunculated fibroids, fibroids with largest diameter inside of the uterine cavity
References
Publications (3)
- BACKGROUNDGupta JK, Sinha A, Lumsden MA, Hickey M. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database Syst Rev. 2012 May 16;(5):CD005073. doi: 10.1002/14651858.CD005073.pub3. PMID 22592701
- BACKGROUNDTorre A, Paillusson B, Fain V, Labauge P, Pelage JP, Fauconnier A. Uterine artery embolization for severe symptomatic fibroids: effects on fertility and symptoms. Hum Reprod. 2014 Mar;29(3):490-501. doi: 10.1093/humrep/det459. Epub 2014 Jan 15. PMID 24430777
- BACKGROUNDMara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):73-85. doi: 10.1007/s00270-007-9195-2. Epub 2007 Oct 18. PMID 17943348