Status:
COMPLETED
Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Leiomyomas
Fertility
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief Summary
The main goal of this study is to evaluate spontaneous fertility after uterine leiomyomas embolization, in women between 18 and 40 years old.
Detailed Description
Uterine artery embolization (UAE) is an effective treatment for leiomyomas, that has been proposed to replace hysterectomy in women who don't want any more pregnancy. Few authors have investigated the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00839722
Start Date
February 1 2009
End Date
July 1 2012
Last Update
June 20 2019
Active Locations (1)
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1
Hopital Poissy St Germain En Laye
Poissy, France, 78300