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临床试验/NCT04537390
NCT04537390招募中不适用

Anti-mullerian Hormone Levels in Healthy Females

Erin Rowell2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年7月19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
发起方
入组人数
100
试验地点
2
主要终点
Anti-mullerian Hormone Levels in Healthy Females

研究概览

简要总结

The purpose of this study is to have a better understanding of the normal blood levels of AMH in females from 0-18 years of age and how the blood AMH levels correspond to a female's reproductive development.

详细描述

Anti-mullerian hormone (AMH) is a chemical in the body that is found in the blood that can estimate the ability of a female to have her own children. It is widely used in adult female cancer patients to predict the onset of menopause and/or the inability to have children that can be associated with chemotherapy and/or radiation treatment. Normal blood levels of AMH are better understood in adults than in children and adolescents. The purpose of this study is to have a better understanding of the normal blood levels of AMH in females from 0-18 years of age and how the blood AMH levels correspond to a female's reproductive development. With a better understanding of normal AMH levels in children, we may be able to better assess a girl's risk of not being able to have children if she is a cancer patient, and may be able to offer her and her family options to increase the chances of having her own children.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Pre- and post-pubertal females
  • Ages 0-18 years old
  • Tanner Stage I- V
  • Undergoing routine outpatient surgical procedure
  • Hernia repair (inguinal, umbilical, epigastric)
  • Excision of benign mass
  • laparoscopic cholecystectomy

排除标准

  • Previous diagnosis of an illness associated with premature ovarian failure (Turner's syndrome, Fragile X permutation carrier) or endocrine disorder associated with irregular menstrual cycles (Cushing's disease, poorly-controlled Thyroid disease, hyperprolactinemia, polycystic ovary syndrome, and congenital adrenal hyperplasia) or insulin-dependent diabetes mellitus or autoimmune disorders
  • Previous diagnosis of any malignancy or any history of systemic/local chemotherapy, radiation therapy, or stem-cell transplant.
  • Previous surgical excision of one ovary or both ovaries
  • Pregnant females
  • All inpatient surgical patients
  • Undergoing non-routine outpatient surgical procedures
  • Central venous catheter placement
  • Supprelin insertion/removal
  • Breast mass excision
  • Gastrostomy tube insertion

研究组 & 干预措施

Blood sample collection

Other

Blood samples are collected for diagnostically assessing how the blood AMH levels correspond to a female's reproductive development

干预措施: Blood sample collection (Diagnostic Test)

结局指标

主要结局

Anti-mullerian Hormone Levels in Healthy Females

时间窗: 3 Years

The primary outcome measure is to get a better understanding of the normal AMH levels in children (girls aged 0-18 years) in order to better assess a girl's risk of not being able to have children if she is a cancer patient, and in offering her and her family options to increase the chances of having her own children

次要结局

未报告次要终点

研究者

发起方
Erin Rowell
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Erin Rowell

Director

Ann & Robert H Lurie Children's Hospital of Chicago

研究点 (2)

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