Clinical trial NCT05271981: Fertility After Uterine Artery Embolization
Official title: Uterine Artery Embolization For Uterine Pathology: What Impact On Fertility?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fertility Disorders
Fertility Issues
Myoma;Uterus
Uterine Artery Embolisation
Keywords: uterine artery embolisation
Fertility Issues
Fertility Disorders
uterine myoma
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Gedeon Richter France
name: Collège National des Gynécologues et Obstétriciens Français
First posted: 2022-03-09
Enrollment: 833
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


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

Primary outcomes:
measure: Rate of live births after embolisation
timeFrame: one year
Secondary outcomes:
measure: Obstetrical outcomes after embolisation
timeFrame: one year
measure: Effectiveness and safety of embolisation
timeFrame: one year
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Henri Azaïs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: