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Clinical Trials/NCT05271981
NCT05271981
Completed
Not Applicable

Uterine Artery Embolization For Uterine Pathology: What Impact On Fertility?

Assistance Publique - Hôpitaux de Paris2 sites in 1 country46 target enrollmentNovember 23, 2022

Overview

Phase
Not Applicable
Intervention
Retrospective data collection
Conditions
Fertility Disorders
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
46
Locations
2
Primary Endpoint
Rate of live births after embolisation
Status
Completed
Last Updated
23 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 23, 2022
End Date
March 29, 2023
Last Updated
23 days ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Female who underwent uterine artery embolisation for uterine pathology

Intervention: Retrospective data collection

Female who underwent uterine artery embolisation for uterine pathology

Intervention: Phone interview

Outcomes

Primary Outcomes

Rate of live births after embolisation

Time Frame: one year

Rate of live births after embolisation (percentage)

Secondary Outcomes

  • Obstetrical outcomes after embolisation(one year)
  • Effectiveness and safety of embolisation(one year)

Study Sites (2)

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