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临床试验/NCT01421095
NCT01421095进行中(未招募)不适用

Ovarian Reserve Testing in Female Young Adult Cancer Survivors

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2011年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
34
试验地点
1
主要终点
Return of menses

研究概览

简要总结

Young adult cancer survivors constitute an under served population to whom fertility potential is particularly important. For female young adult patients, cancer treatment such as alkylating chemotherapy are toxic to the finite number of eggs they have, resulting in risks of infertility and premature menopause related to ovarian failure. Reproductive issues are a major concern for young cancer survivors, but one that is understudied. Young cancer survivors have few tools to measure post-treatment ovarian reserve, or the quantity and quality of remaining eggs4. Accurate determination of ovarian reserve and fertility potential would not only be an important research tool, but also directly impact clinical management. The purpose of this study is to test if basal and provocative ovarian reserve testing can predict return of menses in female young adult cancer survivors, to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors and healthy controls, and to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors on and off of combined estrogen and progesterone hormone products.

Participants will be asked to keep track of their periods over three months. If a participant is taking birth control pills, patches, or vaginal ring, they will asked to come off the birth control for 3 months. Participants will also be asked to undergo ovarian reserve testing by blood draws and pelvic ultrasounds at the start and end of the 3 months.

详细描述

Same as brief summary

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
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenarchal
  • Cancer diagnosis
  • Prior exposure to gonadotoxic therapy, inclusive of chemothearpy, pelvic or total body irradiation, unilateral oophorectomy
  • A minimum of 1 year since completion of gonoadotoxic therapy
  • Intact uterus
  • At least one ovary

排除标准

  • Estrogen receptor positive cancers

研究组 & 干预措施

Basal Testing

Experimental

干预措施: recombinant FSH (Drug)

结局指标

主要结局

Return of menses

时间窗: 3 months

Self reported via bleeding calenders

次要结局

  • Blood levels of FSH(3 months)
  • Blood levels of AMH(3 months)
  • Blood levels of estradiol(3 months)
  • Blood levels of inhibin B(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hui-Chun Irene Su

Assistant Professor of Reproductive Medicine

University of California, San Diego

研究点 (1)

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