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

Primary Purpose

Leiomyomas, Fertility

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

embolization

About this trial

This is an interventional treatment trial for Leiomyomas focused on measuring Uterine embolization, leiomyomas, fertility, myomectomies

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Hopital Poissy St Germain En Laye

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

fertility after embolization

Outcomes

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00839722

First Posted

February 6, 2009

Last Updated

June 18, 2019

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT00839722

Brief Title

Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas

Acronym

EFU

Official Title

Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leiomyomas, Fertility

Keywords

Uterine embolization, leiomyomas, fertility, myomectomies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

fertility after embolization

Intervention Type

Procedure

Intervention Name(s)

embolization

Intervention Description

fertility after embolization

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Time Frame

18 MONTHS

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean Pierre PELAGE, PUPH

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hopital Poissy St Germain En Laye

City

Poissy

ZIP/Postal Code

78300

Country

France

12. IPD Sharing Statement

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Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas

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