Fertility After Uterine Artery Embolization

NCT05271981 | Completed

• 2 other identifiers: APHP211142021-A01868-33
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Uterine leiomyomas (or fibroids) are a common disease (30% of women over 35 years of age) in women of childbearing age and can cause various symptoms such as menometrorrhagia, dysmenorrhoea, pelvic pain and heaviness, and infertility. Uterine artery embolisation, first used in France in 1990, is a safe, effective and less invasive therapeutic technique than surgical treatment (myomectomy or hysterectomy), particularly in the case of numerous and large fibroids. This technique is validated by the French National College of Gynaecologists-Obstetricians (CNGOF) as an alternative treatment for women who do not wish to become pregnant (grade A recommendation), but at present there is little reliable data concerning fertility, the occurrence of pregnancy and the obstetrical prognosis after uterine artery embolisation for fibroids. A recent systematic review of the literature with meta-analysis published very recently showed that 40.5% of patients with a desire for pregnancy were able to become pregnant after embolisation (CI: 33.3%-48.2%) but that the rates of miscarriage, obstetric complications and low birth weight were not negligible (respectively 33.5% (95% CI: 26.3-41%), 25.4% (95% CI = 13-40.2%) and 10% (95% CI = 6.2-14.6%) (Ghanaati et al. 2020). In France, uterine artery embolisation is performed in more than thirty centres in women who have completed their parental project. On the other hand, in the absence of consistent literature, it is performed in patients of childbearing age, when it represents the only acceptable alternative or in the event of contraindication or refusal of surgery by the patient. To our knowledge, there is no large-scale French study to date on the impact of embolisation on fertility and pregnancy outcomes. The aim of this study is to compile a retrospective database of all cases of uterine artery embolisation for uterine pathology performed at the Georges-Pompidou European Hospital (HEGP) since 2007 and to assess the impact of embolisation on fertility in patients of childbearing age.

Conditions

Fertility Issues; Myoma;Uterus; Fertility Disorders; Uterine Artery Embolisation

Keywords

uterine artery embolisation; Fertility Issues; Fertility Disorders; uterine myoma

Outcome Measures

Primary Outcomes (1)

• Rate of live births after embolisation

  Rate of live births after embolisation (percentage)

  one year

Secondary Outcomes (2)

• Obstetrical outcomes after embolisation

  one year

• Effectiveness and safety of embolisation

  one year

Study Arms (1)

Female who underwent uterine artery embolisation for uterine pathology

Other: Retrospective data collection; Other: Phone interview

Interventions

Phone interview OTHER

Call for collecting fertility data and obstetrical issues of the patients

Female who underwent uterine artery embolisation for uterine pathology

Retrospective data collection OTHER

Data collection from the medical file of the patients

Female who underwent uterine artery embolisation for uterine pathology

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Female aged 18 to 45 years who underwent uterine artery embolisation for uterine pathology in our institution between 2007 and September 2020

You may qualify if:

• Women ≥ 18 years, ≤ 45 years at the time of their embolisation
• Uterine pathology responsible for disabling symptoms: uterine leiomyomas with no limitations in size, number or location, adenomyosis
• Having had a uterine artery embolisation between 2007 and September 2020
• Minimum delay of one year after embolisation
• Information and no opposition from patients

You may not qualify if:

• Women \< 18 years and \> 45 years at the time of embolisation
• Uterine artery embolisation for delivery haemorrhage
• Patients under court protection, guardianship or curatorship
• Refusal to participate in this research

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Gedeon Richter France: collaborator
• Collège National des Gynécologues et Obstétriciens Français: collaborator

Study Sites (1)

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Related Publications (1)

• Fabre C, Boeken T, Simon V, Dean C, Sapoval M, Pellerin O, Bats AS, Azais H, Koual M. Fertility outcomes after uterine artery embolization for symptomatic leiomyomas. CVIR Endovasc. 2025 Oct 16;8(1):83. doi: 10.1186/s42155-025-00604-4.

  PMID: 41094296 DERIVED

MeSH Terms

Conditions

Infertility; Myofibroma

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Henri Azaïs, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: November 23, 2022
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (1)