Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids

NCT02577055 | Completed

• 1 other identifier: P140311
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leiomyoma

Keywords

Leiomyoma; Uterine Artery Embolization; Surgery; childbearing age; Fertility; Noninferiority trial

Outcome Measures

Primary Outcomes (1)

• Number of live birth in a year of fertility attempt

  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 Outcomes (20)

• number of adverse effects on fertility (ovarian reserve markers)

  18 months

• number of adverse effects on fertility (state of the uterine cavity)

  18 months

• number of adverse effects on fertility (state of the endometrium

  18 months

• Improvement of symptoms related to fibroids With UFS-QoL questionnaires

  3 months

• Improvement of symptoms related to fibroids With UFS-QoL questionnaires

  6 months

Study Arms (2)

myomectomy

ACTIVE COMPARATOR

Women will be treated with surgical removal of all fibroids, either by laparoscopic or abdominal route

Procedure: myomectomy

embolisation

EXPERIMENTAL

Women will be treated with fertility sparing uterine arteries embolization (i..e. with ultra thin catheter, and particles' diameter \> 500µm)

Procedure: embolisation

Interventions

myomectomy PROCEDURE

Surgical ablation of all fibroids

myomectomy

embolisation PROCEDURE

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.

Also known as: Fertility sparing ultra selective uterine artery embolization

embolisation

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Département de Médecine de la Reproduction, Centre Hospitalier Régionnal Universitaire de Montpellier

Montpellier, 34000, France

Location

Related Publications (3)

• Gupta JK, Sinha A, Lumsden MA, Hickey M. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database Syst Rev. 2012 May 16;(5):CD005073. doi: 10.1002/14651858.CD005073.pub3.

  PMID: 22592701 BACKGROUND

• Torre A, Paillusson B, Fain V, Labauge P, Pelage JP, Fauconnier A. Uterine artery embolization for severe symptomatic fibroids: effects on fertility and symptoms. Hum Reprod. 2014 Mar;29(3):490-501. doi: 10.1093/humrep/det459. Epub 2014 Jan 15.

  PMID: 24430777 BACKGROUND

• Mara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):73-85. doi: 10.1007/s00270-007-9195-2. Epub 2007 Oct 18.

  PMID: 17943348 BACKGROUND

MeSH Terms

Conditions

Leiomyoma

Interventions

Uterine Myomectomy; Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Study Officials

• Antoine Torre, MD, PhD

  Faculté de médecine de Montpellier-Nîmes, Université de Montpellier 1, France.

  PRINCIPAL INVESTIGATOR

• Arnaud Fauconnier, MD, PhD

  UFR des sciences de la santé Simone Veil, Université de Versailles Saint Quentin en Yvelines, France.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: October 16, 2015
• Study Start: April 1, 2016
• Primary Completion: October 16, 2019
• Study Completion: October 16, 2019
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)