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临床试验/NCT02482467
NCT02482467终止不适用

Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2014年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
105
试验地点
2
主要终点
Age of puberty

研究概览

简要总结

Puberty and long-term ovarian function of patients with a ovarian prenatal cyst has not described to date.

详细描述

The prenatal diagnosis of ovarian cysts is a common disease with an estimated incidence of 1 case per 2500 births. This pathology is the first diagnosis of abdominal cystic picture on the female fetus in the third trimester of pregnancy.Various complications of ovarian cysts have been described, such as ovarian torsion, breaking the cyst, hemorrhage intra cystic and compression of adjacent viscera. A conservative attitude for uncomplicated cysts is proposed in the literature but surgical care and / or puncture can be made to prevent the occurrence of complications and thus to protect ovarian tissue.However, no data on puberty and long-term ovarian prognosis in this disease is published in the literature. Without this information, no support for the recommendation of a prenatal ovarian cyst can be established formally.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
6 Years 至 24 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Collection of the written consent by the patients or the parents
  • Membership in a health insurance scheme
  • Group 1 : girl with prenatal ovarian cyst group 2: girl without prenatal ovarian cyst

排除标准

  • Refusal of participation of the patient or one of the two parents
  • Deprived of freedom
  • Pregnancy and current feeding
  • Prenatal, neonatal or infantile history of ovarian pathology (Group 2)
  • Genital congenital deformation or malformation syndrome gives a complex (group 2)
  • Endocrine pathology except the juvenile disorders (group 2)

结局指标

主要结局

Age of puberty

时间窗: 1 day

Clinical data and clinical history

次要结局

  • Follicular reserve(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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