Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids

NCT ID: NCT02577055

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-10-16

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.

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.

Conditions

Leiomyoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

myomectomy

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

Group Type: ACTIVE_COMPARATOR

myomectomy

Intervention Type: PROCEDURE

Surgical ablation of all fibroids

embolisation

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

Group Type: EXPERIMENTAL

embolisation

Intervention Type: 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.

Interventions

myomectomy

Surgical ablation of all fibroids

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Fertility sparing ultra selective uterine artery embolization

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine Torre, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Arnaud Fauconnier, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

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

Montpellier, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 22592701 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24430777 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17943348 (View on PubMed)

Other Identifiers

P140311

Identifier Type: -

Identifier Source: org_study_id