Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The main goal of this study is to evaluate spontaneous fertility after uterine embolization, in women between 18 and 40 years old
18 MONTHS
No
Jean Pierre PELAGE, PUPH
Principal Investigator
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health
P071006
NCT00839722
February 2009
July 2012
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