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CompletedNCT05271981

Fertility After Uterine Artery Embolization

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

Status
Completed
Phase
Study type
Observational
Enrollment
46 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERRetrospective data collectionData collection from the medical file of the patients
OTHERPhone interviewCall for collecting fertility data and obstetrical issues of the patients

Timeline

Start date
2022-11-23
Primary completion
2023-03-29
Completion
2023-03-29
First posted
2022-03-09
Last updated
2026-04-09

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05271981. Inclusion in this directory is not an endorsement.

Fertility After Uterine Artery Embolization (NCT05271981) · Clinical Trials Directory