EFU: Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00839722

Collaborator

(none)

Enrollment

Location

Arm

40.9

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leiomyomas Fertility	Procedure: embolization	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 fertility after embolization	Procedure: embolization fertility after embolization

Arm

Intervention/Treatment

Experimental: 1

fertility after embolization

Procedure: embolization

fertility after embolization

Outcome Measures

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 [18 MONTHS]

Secondary Outcome Measures

The functional outcome, the efficiency, complications and side-effects of UAE will be also reported especially on the reproduction function [18 MONTHS]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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