跳至主要内容
临床试验/NCT02975245
NCT02975245已完成不适用

Short Term Genetic Effects of Chemotherapy on Male Germ Cells

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
the differences in DNA between sperm collected before chemotherapy to sperm collected after the first round of chemotherapy using whole exome sequencing.

研究概览

简要总结

This study will determine the short-term effects of chemotherapy on sperm DNA.The study involves the collection of semen sample through ejaculation prior to initiation of chemotherapy and up to three time points after initiation of chemotherapy.

详细描述

While medical advances in the area of cancer treatment have successfully improved the overall detection and treatment of many cancers affecting men and women alike, these very treatment modalities can adversely affect their reproductive capacity.

Certain types of chemotherapy, such as alkylating agents, are notorious for placing patients at high risk for infertility. For men, the best recommendation for patients undergoing such therapy is to cryopreserve semen prior to initiation of chemotherapy. Unfortunately, this may not always occur. Some patients have been noted to present to discuss fertility preservation options after completing their first cycle of chemotherapy. In this situation, they will most likely still have sperm which was produced prior to chemotherapy that can be collected even if the stem cells producing the sperm have been damaged or destroyed. However, there are no national guidelines addressing this particular situation. Typically, physicians may advise men to avoid conception anywhere from three months to two years after the final dose of chemotherapy to ensure all exposed germ cells have passed through and only newly formed germ cells remain.

It is crucial to further assess the effects of chemotherapeutic agents on male germ cells in the short window of time between exposure and potential sterility. If a safe time frame could be determined to collect sperm after a single dose of chemotherapy, then these men could be given a second chance to retain their fertility potential.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Be scheduled to undergo treatment with chemotherapeutic agents for a medical indication
  • Be able to produce semen samples prior to chemotherapy and one week after first round of chemotherapy

排除标准

  • Men who have previously been treated with chemotherapeutic agents.
  • Men with significant oligospermia or azospermia.

结局指标

主要结局

the differences in DNA between sperm collected before chemotherapy to sperm collected after the first round of chemotherapy using whole exome sequencing.

时间窗: 5 years

Sperm count test analyzes the health and viability of sperm, as it takes into account sperm number, motility, and morphology.

次要结局

  • changes in sperm quality from sperm collected before the initiation of chemotherapy to sperm collected after first round of chemotherapy using sperm count test.(5 years)

研究者

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

Kyle Orwig

Professor

University of Pittsburgh

研究点 (1)

Loading locations...

相似试验