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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05271981
Other study ID # APHP21114
Secondary ID 2021-A01868-33
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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