Uterine Artery Embolization For Uterine Pathology: What Impact On Fertility?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Rate of live births after embolisation
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Female who underwent uterine artery embolisation for uterine pathology
干预措施: Retrospective data collection (Other)
Female who underwent uterine artery embolisation for uterine pathology
干预措施: Phone interview (Other)
结局指标
主要结局
Rate of live births after embolisation
时间窗: one year
Rate of live births after embolisation (percentage)
次要结局
- Obstetrical outcomes after embolisation(one year)
- Effectiveness and safety of embolisation(one year)
