Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Feb 6, 2009
Trial Information
Current as of June 23, 2025
Completed
Keywords
ClinConnect Summary
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 results of UAE in women desiring subsequent pregnancy. It might represents an alternative to multiples myomectomies by laparotomy , which results on postoperative fertility remain disappointing. The main goal of this study is to evaluate spontaneous fertility after uterine embolization, in women between 18 and 40 years old. The functional outcome, the efficiency, complications and side-effects...
Gender
FEMALE
Eligibility criteria
- 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
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Poissy, , France
Patients applied
Trial Officials
Jean Pierre PELAGE, PUPH
Principal Investigator
Assistance Publique - Hôpitaux de Paris
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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