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Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas

Phase 2
18 Years
40 Years
Not Enrolling
Leiomyomas, Fertility

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Trial Information

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.

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

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:


Safety Issue:


Principal Investigator

Jean Pierre PELAGE, PUPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

February 2009

Completion Date:

July 2012

Related Keywords:

  • Leiomyomas
  • Fertility
  • Uterine embolization
  • leiomyomas
  • fertility
  • myomectomies
  • Leiomyoma
  • Myofibroma