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临床试验/NCT04137965
NCT04137965招募中不适用

Testicular Function After Testicular Torsion

Herlev and Gentofte Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
1
主要终点
Sperm concentration

研究概览

简要总结

The purpose of this study is to evaluate testicular function measured as testosterone level and semen quality.

详细描述

Men having undergone surgery for testicular torsion between 01.01.2003 - 12.31.2012 will receive a invitation to participate in this study. It is expected that 110 patients can be identified and about 65% of them will participate. These men will undergo a andrological evaluation, deliver a semen sample, have a blood sample taken and undergo a testicular ultrasound.

Control group:

Men attending the fertility counseling at Herlev hospital will be offered participation in this study. The fertility counseling demands that men who contact the clinic have never had their sperm analyzed, have not tried to get pregnant with their partner for more than a year and that they have no prior knowledge of their fertility.

Primary endpoint:

  • Semen quality measured as sperm concentration
  • Total testosterone level

研究设计

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

入排标准

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

入选标准

  • Men with a verified testicular torsion operated at Herlev and Gentofte hospital between 01.01.2003 and 12.31.2012

排除标准

  • Retentio testis
  • Varicocele
  • Previous treatment with chemo- or radiation therapy
  • Genetic disposition for infertility
  • Anejculation
  • Retrograde ejaculation

结局指标

主要结局

Sperm concentration

时间窗: 8-17 years after surgical intervention

Amount of motile sperm cells (\* 10\^6)

Testosterone level

时间窗: 8-17 years after surgical intervention

ng/ml

次要结局

  • Semen parameters as an indicator of overall testicular exocrine function(8-17 years after surgical intervention)
  • Hormone level as an indicator of testicular endocrine function(8-17 years after surgical intervention)
  • MAR test result correlated to the type of surgery(8-17 years after surgical intervention)
  • Difference in sperm morphology and motility correlated to the type of surgery and compared to control group(8-17 years after surgical intervention)
  • Paternity as a measure of fertility(8-17 years after surgical intervention)

研究者

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

Frederik Møller Jacobsen

Principal Investigator

Herlev and Gentofte Hospital

研究点 (1)

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