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临床试验/EUCTR2016-003546-84-DK
EUCTR2016-003546-84-DK进行中(未招募)1 期

Denosumab and male infertility: a randomized double-blinded intervention study

Dpt. of Growth and Reproduction0 个研究点目标入组 90 人开始时间: 2016年9月16日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
90

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

  • Men > 18 years of age refered due to infertility in need for further investigation with
  • Sperm count > 0,05 mio./ml.
  • The men have either sperm count <15 mio./ml or
  • <40 % motile spermatozoer (A) or
  • <4 % morphological normale spermatozoer (strict criteria)
  • 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 95
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Men with chronic diseases (diabetes mellitus, thyroid disease, endocrine diseases requirering treatment, malignant diseases or diseases known to be affected by- or interfere with vitamin D supplements (granulomatous diseases such as sarcoidosis, tuberculosis, wegeners, vasculitis as well as inflammatory bowel diseases e.g. chron’s disease or ulcerative colitis etc).
  • Men with active or previous malignant disease
  • Any case with indication for tesis biopsy,
  • Serum ionized calcium < 1,15 mmol/l
  • Total calcium < 2.14 mmol/l
  • Poor dental status og dental implants
  • Men with obstructive oligospermia or who has been vasectomized
  • Serum Inhibin B < 30 pg/ml
  • Abnormal karyotype

研究者

发起方
Dpt. of Growth and Reproduction

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