Clinical trial · Interventional
Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas
NCT00839722CI-TRIAL-00039148EFUcompletedPhase 2ClinicalTrials.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)
The main goal of this study is to evaluate spontaneous fertility after uterine leiomyomas embolization, in women between 18 and 40 years old.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fertility | — | UNRESOLVED | — |
| Leiomyomas | Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| embolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- fertility after embolization
- interventionNames
- Procedure: embolization
Primary outcomes (1)
- measure
- The main goal of this study is to evaluate spontaneous fertility after uterine embolization, in women between 18 and 40 years old
- timeFrame
- 18 MONTHS
Secondary outcomes (1)
- measure
- The functional outcome, the efficiency, complications and side-effects of UAE will be also reported especially on the reproduction function
- timeFrame
- 18 MONTHS
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * age \> 18 years and ≤ 40 years * diffuse POLYMYOMATOSIS or recurrent POLYMYOMATOSIS after surgery requiring multiple myomectomies by laparotomies i.e. at least 3 fibroids of significant diameter (including 1 fibroid longer than 3 cm using ultrasound) * symptomatic fibroids causing chronic pelvic pain and/or pelvic pressure and/or haemorrhage genital * immediate desire for future pregnancy without indication for assisted medical reproduction (bilateral hydrosalpinx, male infertility) * covered by french health insurance * patient knowing to read and understanding French * patient signing of an informed consent form, after appropriate information has been provided Exclusion Criteria: * evolutionary pregnancy * medical emergency situation * Contraindication by the surgery or Uterine Artery Embolisation : allergy, severe renal failure, immune system deficiency or anesthesic * age \> 40 years * fibroids accessible to laparoscopies removal (less than 3 fibroids measuring 3 cm or 1 dominant fibroid measuring 8 cm) or hysteroscopies resection (submucous fibroids type 0 or I according to DONNEZ'S classification) or abdominal myomectomy indicated by large volume single intramural or subserosal fibroid * abnormal hormonal profile at day 3 of the cycle evaluated during a pluridisciplinary consultation * Male infertility requiring management for assisted medically reproduction (systematic * spermograms will be obtained in routinely) * amenorrhea * visible hydrosalpinx for ultrasonography or MRI * no explored an adnexal mass * diffuse adenomyosis as the dominant disease * no affiliation of social coverage * bad comprehension of french preventing an informed consent form or information of self questionnaires * social situation posing to difficulty of follow-up
References
Publications (0)
Data not yet available
No reference posted for this study.