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临床试验/ISRCTN80724703
ISRCTN80724703已完成不适用

The effect of Testosterone Undecanoate (TU) alone or combined with Depot Medroxyprogesterone Acetate (DMPA) on sperm production of Indonesian fertile me

DP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)0 个研究点目标入组 40 人开始时间: 2004年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
Male

入选标准

  • Current inclusion criteria as of 24/09/2007:
  • Male participants:
  • 1. Age 21 to 45 years
  • 2. Good general health
  • 3. Blood parameters (peptide hormones, clinical chemistry, haematology, Prostate Specific Antigen [PSA]) in normal range
  • 4. Semen parameters in normal range:
  • 4.1. Sperm concentration 20 million/mL
  • 4.2. Sperm morphology greater than 30% normal
  • 4.3. Sperm 50% forwardly motile
  • 5. Couples must be in a stable relationship, dissatisfied with their current method of contraception and have no history of infertility
  • Female partners:
  • 1. Age of consent to 35 years
  • 2. Regular menstrual cycles
  • 3. No history of Pelvic Inflammatory Disease (PID) in last 12 months
  • 4. Not pregnant
  • 5. Willing to have physical exam and to participate in trial
  • Previous inclusion criteria:
  • Male participants:
  • 1. Age 21 to 45 years
  • 2. Good general health
  • 3. Blood parameters (peptide hormones, clinical chemistry, haematology) in normal range
  • 4. Semen parameters in normal range:
  • a. sperm concentration 20 million/mL
  • b. sperm morphology greater than 30% normal
  • c. sperm 50% forwardly motile
  • Female partners:
  • 1. Age of consent to 35
  • 2. Regularly cycling
  • 3. No history of Pelvic Inflammatory Disease (PID) in last 12 months
  • 4. Not pregnant
  • 5. Willing to have physical exam and to participate in trial

排除标准

  • Added 24/09/07:
  • 1. History of active or chronic cardiac, renal, hepatic or prostatic disease or other serious diseases such as diabetes mellitus, hyperlipoproteinemia, etc.
  • 2. Men with active or persistent genitourinary infection
  • 3. Use of medication such as sex steroids or barbiturate
  • 4. Couples in which the wife is breastfeeding

研究者

发起方
DP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)

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