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
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