NCT00839722

Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Leiomyomas
• Fertility

Interventions

Type	Name	Description
PROCEDURE	embolization	fertility after embolization

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-07-01
• Completion: 2012-07-01
• First posted: 2009-02-09
• Last updated: 2019-06-20

Locations

1 site across 1 country: France