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临床试验/NCT06211569
NCT06211569招募中不适用

Study of the Prevalence of Endometriosis and Adenomyosis in Women of Childbearing Age Consulting for Non-medical Oocyte Self-preservation

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年4月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
2
主要终点
Transvaginal pelvic ultrasound

研究概览

简要总结

Our study aims to assess the prevalence of adenomyosis and endometriosis in patients consulting for elective fertility preservation through the diagnosis of these pathologies by transvaginal pelvic ultrasound. Imaging data will be compared with clinical data (patient characteristics, clinical symptoms) as well as the assessment of anxiety, depression, and quality of life collected from the women.

详细描述

Adenomyosis and endometriosis are two heterogeneous benign gynecological pathologies, in terms of the presence of diverse phenotypes and their symptomatic presentation: While some women are entirely asymptomatic, others experience pelvic pain, infertility, or abnormal uterine bleeding.

Assessing the prevalence of these two pathologies is challenging: On the one hand, a significant number of women are asymptomatic and not considered in the calculation; on the other hand, endometriosis and adenomyosis are often underdiagnosed, leading to delayed diagnosis.

Endometriosis and adenomyosis are frequently associated. Improving knowledge about the epidemiology of endometriosis and adenomyosis is crucial as both are major causes of clinical symptoms that adversely affect the quality of life in numerous women. This is a significant issue for women's health due to the associated suffering, numerous surgical interventions, healthcare expenses, and the suggested link with pathologies that may affect other organs. Understanding the disease could lead to improved treatment and the development of preventive strategies.

Therefore, it is urgent to determine the frequency of endometriosis and adenomyosis, as well as the correlation between women's characteristics, especially their clinical symptoms, and different phenotypes. In order to assess the prevalence of adenomyosis and endometriosis in a population of women of reproductive age, the investigators intend to conduct this single-center study focusing on patients consulting for non-medical fertility preservation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
29 Years 至 37 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Woman aged between 29 and 37
  • Consultant for non-medical fertility preservation in the Reproductive Medicine Unit Port Royal, Cochin
  • Informed and not opposed to this research
  • Affiliated to a social security scheme

排除标准

  • Pregnant women
  • Refusing to take part in the study
  • Under court protection, curatorship or guardianship
  • Women with a known malformation of the genital tract

研究组 & 干预措施

Patients

Women of childbearing age, consulting for elective fertility preservation

干预措施: Usual follow-up (Other)

结局指标

主要结局

Transvaginal pelvic ultrasound

时间窗: Up to month 6

Search for endometriosis and adenomyosis on transvaginal pelvic ultrasound and characterisation of lesions.

次要结局

  • Quality of life assessment (WHO-QOL-BREF)(Inclusion)
  • Hospital Anxiety and Depression Scale (HADS)(Inclusion)
  • Self-questionnaire(Inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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