跳至主要内容
临床试验/EUCTR2015-002521-19-ES
EUCTR2015-002521-19-ES进行中(未招募)不适用

Pilot study on the effect of FSH treatment in epigenetic characteristics of sperm in infertile patients with severe oligozoospermia

Instituto de Investigación Sanitaria La Fe0 个研究点开始时间: 2015年8月12日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Male

入选标准

  • 1.Age 30-40 years
  • 2. Total sperm concentration (concentration / mL million
  • x volume in ml) from 1-10 million (oligozoospermia) at least 2
  • Semen obtained with a period of sexual abstinence 2-4
  • days and at least a separation between 7 days.
  • 3. Caucasian.
  • 4. Inability of the couple to achieve a pregnancy after one year of
  • sex without using any birth control.
  • 5. 2-12 FSH IU / mL.
  • 6. Total Testosterone greater than 300 ng / mL and bioavailable testosterone,
  • calculated from albumin, Sex Hormone Binding Globuling -
  • SHBG- greater than 145 ng / dL
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 45
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. Age between 30-40 years.
  • 2. Caucasian.
  • 3. Concentration and sperm motility above percentile
  • 50 according to the parameters of the fifth edition of the Organization
  • World Health Organization (WHO) in at least two semen in the
  • least 2 semen obtained with a period of abstinence
  • sexual 2-4 days and at least a separation between 7 days.
  • 4. increased seminal volume of 1 ml.
  • 5. Estradiol less than 50 pg / mL
  • 6. FSH less than 4.5 IU / L.
  • 7. Total Testosterone greater than 300 ng / dL and bioavailable testosterone
  • greater than 145 ng / dL.
  • 8. Have not been vasectomized.
  • 9. Have been parents in the past five years.

研究者

发起方
Instituto de Investigación Sanitaria La Fe

相似试验