Fertility After Uterine Artery Embolization

NCT ID: NCT05271981

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 833 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-23
• Study Completion Date: 2023-11-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Female who underwent uterine artery embolisation for uterine pathology

Retrospective data collection

Intervention Type: OTHER

Data collection from the medical file of the patients

Phone interview

Intervention Type: OTHER

Call for collecting fertility data and obstetrical issues of the patients

Interventions

Retrospective data collection

Data collection from the medical file of the patients

Intervention Type: OTHER

Phone interview

Call for collecting fertility data and obstetrical issues of the patients

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gedeon Richter France

UNKNOWN

Sponsor Role: collaborator

Collège National des Gynécologues et Obstétriciens Français

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henri Azaïs, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Européen Georges Pompidou

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Natacha Nohilé

Role: CONTACT

natacha.nohile@aphp.fr

331 56 09 59 82

Facility Contacts

Henri Azaïs, MD, PhD

Role: primary

henri.azais@aphp.fr

Meriem Koual, MD, PhD

Role: backup

meriem.koual@aphp.fr

References

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.

Reference Type: DERIVED

PMID: 41094296 (View on PubMed)

Other Identifiers

2021-A01868-33

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP21114

Identifier Type: -

Identifier Source: org_study_id