Fertility After Uterine Artery Embolization

Recruiting

• Conditions: Fertility Issues; Uterine Artery Embolisation; Myoma;Uterus; Fertility Disorders
• Interventions: Other: Retrospective data collection; Other: Phone interview

• Registration Number: NCT05271981
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-02-28
• Study First Posted: 2022-03-09
• Study Start: 2022-11-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-19
• Primary Completion: 2023-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 833

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Female who underwent uterine artery embolisation for uterine pathology	Phone interview	-
Female who underwent uterine artery embolisation for uterine pathology	Retrospective data collection	-

Primary Outcome Measures

Name	Time	Method
Rate of live births after embolisation	one year	Rate of live births after embolisation (percentage)

Secondary Outcome Measures

Name	Time	Method
Obstetrical outcomes after embolisation	one year	* Pregnancy rate (percentage) ; * Miscarriage rate (percentage) ; * Assisted reproduction rate; * Obstetric complication rates (haemorrhage, caesarean section, prematurity, pre-eclampsia, placental disorders)
Effectiveness and safety of embolisation	one year	* Complication rate of embolisation (percentage); * Post-embolisation myomectomy and hysterectomy rates (percentage)

Trial Locations

Locations (1)

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France