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临床试验/NCT04762615
NCT04762615已完成不适用

Impact of the Immunosuppressive Treatment, X-ray Exposition and Renal Pathology on Ovarian Reserve in Young Women

Wroclaw Medical University1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
153
试验地点
1
主要终点
Potential impact of X-ray exposition on ovarian reserve

研究概览

简要总结

Aging, renal pathology (eg SLE, ADPKD), X-ray exposition and pharmacological treatments, especially previous strong immunosuppression, may negatively influence the ovarian reserve in childbearing age women. Anti-Müllerian hormone (AMH) is regarded as biomarker for ovarian reserve.

Every female with renal disease regularly menstruating that met exclusion criteria could have participated. The aim was to assess ovarian reserve in female patients with normal menstrual cycle and kidney disease, including kidney transplant recipients.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Conscious written approval
  • Autoimmunological disorder with kidneys affection/ kidney transplant recipient- Regular menstrual cycles
  • Age above 18 years old

排除标准

  • Irregular menstrual cycles
  • Menopause
  • Chemiotherapy or radiotherapy in the past
  • Surgical interventions within ovaries
  • Hypogonadotropic hypogonadism
  • Folliculoma
  • Age under 18 years old

结局指标

主要结局

Potential impact of X-ray exposition on ovarian reserve

时间窗: 1 day

Analysis of the impact of X-ray exposition \[mSv\] on AMH serum level \[ng/ml\]

To compare AMH levels between three groups

时间窗: 1 day

Serum AMH levels \[ng/ml\] measured using ELISA and compared between three groups

Potential impact of antiproliferative drugs on ovarian reserve

时间窗: 1 day

Analysis of the impact of antiproliferative drugs on AMH serum level \[ng/ml\]

Potential impact of underlying kidney disease on ovarian reserve

时间窗: 1 day

Analysis of the impact of underlying kidney disease (including SLE) on AMH serum level \[ng/ml\]

次要结局

未报告次要终点

研究者

发起方
Wroclaw Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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