Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas (EFU)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00839722
First received: February 6, 2009
Last updated: October 12, 2012
Last verified: June 2011
  Purpose

The main goal of this study is to evaluate spontaneous fertility after uterine leiomyomas embolization, in women between 18 and 40 years old.


Condition Intervention Phase
Leiomyomas
Fertility
Procedure: embolization
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • The main goal of this study is to evaluate spontaneous fertility after uterine embolization, in women between 18 and 40 years old [ Time Frame: 18 MONTHS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The functional outcome, the efficiency, complications and side-effects of UAE will be also reported especially on the reproduction function [ Time Frame: 18 MONTHS ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: February 2009
Study Completion Date: July 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
fertility after embolization
Procedure: embolization
fertility after embolization
Other Name: embolization

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 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 of UAE will be also reported especially on the reproduction function. This will be an open prospective, multicentric, non-randomized, interventional study. Within the context of an experimental phase II essay, an optimal Simon plan with 2 stages is required. The current study is the first step. It will include 30 patients treated in the Gynecology departments of Pr MADELENAT and Pr Mathieu CAPUTO (BICHAT Hospital, Paris) and Pr Ville (Poissy Hospital, Poissy). Preliminary results will be reported at 1 year postoperative which correspond to the participation period of 15 months and the total follow-up period will be 2 years. Inclusion criteria will be the women whom multiples myomectomies by laparotomy would be necessary, with symptomatic myoma and an immediate wish of pregnancy. The number of first pregnancies among women who try to be pregnant (conception rate) and among all women (fertility rate) will be calculated. The effects of the embolisation on the genital physiology, the leiomyomas and the ovarian function will be evaluated by questionaries, clinical examination, biology exams (hormones), ultrasound and IRM at 3, 6 and 12 months, and coelioscopy and hysteroscopy at 3 months. The pregnancy progress will be evaluated in a longer study.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839722

Locations
France
Hopital Poissy St Germain En Laye
Poissy, France, 78300
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean Pierre PELAGE, PUPH Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00839722     History of Changes
Other Study ID Numbers: P071006
Study First Received: February 6, 2009
Last Updated: October 12, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Uterine embolization
leiomyomas
fertility
myomectomies

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on April 16, 2014