Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids (Lune2)

April 16, 2021 updated by: Assistance Publique - Hôpitaux de Paris

Purpose of this study:

To establish the superiority of myomectomy versus Uterine Artery Embolization, in women with multiple symptomatic fibroids and no other infertility factor, seeking to conceive.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

The use of uterine artery embolization (UAE) to treat symptomatic fibroids in women seeking future fertility remains a matter of debate, because of possible adverse effects on ovarian reserve and embryo implantation. In women with associated infertility factors, not eligible for myomectomy, poor fertility was obtained after UAE. On the other hand, fertility of women eligible for surgical myomectomy, deciding to have a UAE, compares favourably with the fertility obtained after myomectomy.

Study design:

Eligible women will be explored to pull out any other infertility factors such as:

  • tubal factors (no hydrosalpinx at MRI, tubal permeability assessed by hysterosalpingography and/or negative serology of for Chlamydia)
  • Endometriosis (clinical history and examination, MRI)
  • Ovarian factors (normal AMH dosage, and Antral follicular count)
  • Male factors (normal spermogram of the Partner if possible)

Women will be treated with fertility sparing ultra selective uterine artery embolization, or surgical removal of multiple myomas.

A six months convalescence/cicatrisation period will be respected, then women will be allowed to intend to conceive.

Several elements will be prospectively followed:

  • Spontaneous pregnancy from 6 months to 18 months after treatment
  • Pregnancy outcomes
  • Symptoms and quality of live with UFS-QoL and WHQ questionnaires, at 3, 6, 12 and 18 months after treatment
  • Uterine size with MRI, before and 3 months after treatment.
  • Aspect of the uterine cavity with hysteroscopy before and 3 months after treatment.
  • Ovarian reserve with AMH dosage, and Antral follicular count before and 3 months after treatment.
  • Volume and molecular pattern of the endometrium at the implantation window before and 3 months after treatment (optional).
  • Treatment's adverse effects.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34000
        • Département de Médecine de la Reproduction, Centre Hospitalier Régionnal Universitaire de Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged ≥ 18 and ≤ 43 years old
  • At least one interstitial fibroid more than 3 cm on MRIat MRI)
  • with symptoms: genital bleeding, chronic pelvic pain or heaviness, anemia, or infertility > 1 year.
  • With immediate desire to conceive
  • without assisted reproductive indication: no tubal infertility, menstrual irregularities, hydrosalpinx, endometriosis, adenomyosis, or male infertility.
  • Patient with health insurance, who can read and understand French and who has given written consent

Exclusion Criteria:

  • Ongoing regnancy
  • Emergency Situation
  • Contraindication to surgery or uterine embolization: allergy to contrast medium , renal failure, immunodeficiency, contraindication to anesthesia, subserosal or submucosal pedunculated fibroids, fibroids with largest diameter inside of the uterine cavity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: myomectomy
Women will be treated with surgical removal of all fibroids, either by laparoscopic or abdominal route
Procedure: myomectomy
Surgical ablation of all fibroids
Experimental: embolisation
Women will be treated with fertility sparing uterine arteries embolization (i..e. with ultra thin catheter, and particles' diameter > 500µm)
Procedure: embolisation
Embolisation of the peri-myoma vascular network, with non-resorbable particles of >500 µm diameter, using an ultra thin catheter introduced through the vascular network up to the uterine arteries under radioscopic control.
Other Names:
  • Fertility sparing ultra selective uterine artery embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of live birth in a year of fertility attempt
Time Frame: 18 months
Women will be allowed to attempt fertility 6 months after treatment. Effective fertility attempts will be prospectively followed. Final fertility will be assessed one year later.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of adverse effects on fertility (ovarian reserve markers)
Time Frame: 18 months
18 months
number of adverse effects on fertility (state of the uterine cavity)
Time Frame: 18 months
18 months
number of adverse effects on fertility (state of the endometrium
Time Frame: 18 months
18 months
Improvement of symptoms related to fibroids With UFS-QoL questionnaires
Time Frame: 3 months
3 months
Improvement of symptoms related to fibroids With UFS-QoL questionnaires
Time Frame: 6 months
6 months
Improvement of symptoms related to fibroids With UFS-QoL questionnaires
Time Frame: 12 months
12 months
Improvement of symptoms related to fibroids With UFS-QoL questionnaires
Time Frame: 18 months
18 months
Quality of life With QSF questionnaires, a French version of the WHQ questionnaire
Time Frame: 3 months
3 months
Quality of life With QSF questionnaires, a French version of the WHQ questionnaire
Time Frame: 6 months
6 months
Quality of life With QSF questionnaires, a French version of the WHQ questionnaire
Time Frame: 12 months
12 months
Quality of life With QSF questionnaires, a French version of the WHQ questionnaire
Time Frame: 18 months
18 months
Number of adverse effects during pregnancy : Rate of Miscarriage
Time Frame: Until 30 months
Until 30 months
Number of adverse effects during pregnancy : extra-uterine pregnancy
Time Frame: until 24 months
until 24 months
Number of adverse effects during pregnancy : small for gestational age
Time Frame: Until 30 months
Until 30 months
Number of adverse effects during pregnancy : foetal death
Time Frame: Until 30 months
Until 30 months
Number of adverse effects during pregnancy : uterine rupture
Time Frame: Until 30 months
Until 30 months
Number of adverse effects during pregnancy : abnormal placental position and implantation
Time Frame: Until 30 months
Until 30 months
Number of adverse effects during pregnancy : preterm delivery
Time Frame: Until 29 months
Until 29 months
Number of adverse effects during pregnancy : delivery hemorrhagy
Time Frame: Until 30 months
Until 30 months
number of adverse effects in the newborn
Time Frame: At day 3 of life
Rate of small for gestational age, delivery presentation, health of newborn children (Apgar score, cord pH, admission in the neonatology service)
At day 3 of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Antoine Torre, MD, PhD, Faculté de médecine de Montpellier-Nîmes, Université de Montpellier 1, France.
  • Study Director: Arnaud Fauconnier, MD, PhD, UFR des sciences de la santé Simone Veil, Université de Versailles Saint Quentin en Yvelines, France.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

October 16, 2019

Study Completion (Actual)

October 16, 2019

Study Registration Dates

First Submitted

July 20, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (Estimate)

October 16, 2015

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P140311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leiomyoma

Clinical Trials on myomectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe