Fertility After Uterine Artery Embolization

Fertility Disorders Clinical Trial

— FERTI-EMBOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05271981
• Other study ID #: APHP21114
• Secondary ID: 2021-A01868-33
• Status: Recruiting
• Start date: November 23, 2022
• Est. completion date: November 2023

Study information

• Verified date: April 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Natacha Nohilé
• Phone: 331 56 09 59 82
• Email: natacha.nohile[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 833
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Disorders
• Fertility Issues
• Infertility
• Leiomyoma
• Myoma;Uterus

Intervention

Other:
• Retrospective data collection
Data collection from the medical file of the patients
• Phone interview
Call for collecting fertility data and obstetrical issues of the patients

Locations

Country	Name	City	State
France	Hôpital Européen Georges Pompidou	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Collège National des Gynécologues et Obstétriciens Français, Gedeon Richter France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of live births after embolisation	Rate of live births after embolisation (percentage)	one year
Secondary	Obstetrical outcomes after embolisation	Pregnancy rate (percentage) ; Miscarriage rate (percentage) ; Assisted reproduction rate; Obstetric complication rates (haemorrhage, caesarean section, prematurity, pre-eclampsia, placental disorders)	one year
Secondary	Effectiveness and safety of embolisation	Complication rate of embolisation (percentage); Post-embolisation myomectomy and hysterectomy rates (percentage)	one year