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临床试验/EUCTR2021-003451-42-DK
EUCTR2021-003451-42-DK进行中(未招募)1 期

FITMI - First In Treating Male Infertility

Dept. of Growth and Reproduction0 个研究点目标入组 282 人开始时间: 2021年6月28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
282

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

  • - Infertile men >18 years and <60 years of age with reduced sperm production (Sperm concentration <20 mio/mL)
  • - Serum AMH > 38 pmol/L
  • 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 282
  • 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 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
  • - Men in treatment for osteoporosis
  • - Serum ionized calcium < 1,18 mmol/L, Total calcium < 2.14 mmol/L or Albumin corrected calcium <2.17 mmol/L
  • - Serum 25OHD < 25 nmol/L
  • - eGFR <60 mL/min/1.73m^2
  • - Poor dental status og dental implants
  • - Men with obstructive oligospermia (Sperm volume <0.9 mL) or who has been vasectomized
  • - Latex allergy
  • - Any case with indication for tesis biopsy,

研究者

发起方
Dept. of Growth and Reproduction

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