EUCTR2007-002859-16-IT进行中（未招募）不适用
A randomized, double blind, placebo controlled, parallel group study to determine the effect of Elocalcitol on sperm parameters in infertile male patients - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- BIOXELL SPA
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
- •- Male patients aged 18-45 years - Infertility > 1 year and regular sexual intercourses with a fertile woman - Sperm parameters: total motility (?a + b + c?) 10-40% (this criteria should be met for both samples collected at V2 and V3, an analysis performed in the previous 6 months can replace the V2 evaluation) - Normal rheologic characteristic of the semen (appearance, consistency, liquefaction), volume and pH in the normal range - Negative urine, urethral swab and sperm culture - Ability to fully understand all study procedures and to provide written informed consent to study participation - Ability to comply with dosing and study visits scheduled for the duration of 7 months
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Genetic causes of infertility (tests performed before the enrolment are acceptable) - Varicocele and testicular hypotrophy by clinical evaluation - Patients who have undergone testicular surgery within the 3 months prior to the enrolment - Previous or present testicular cancer - Previous testicular trauma or torsion - General endocrinological disease (documented by clinical examination and hormonal laboratory tests: gonadotropins,Testosterone, tests performed in the previous 12 months will be accepted) - Present or previous cryptorchidism - Presence of antisperm antibodies - Evidence of hepatic disease (total bilirubin > 1.5 x upper limit of normal, or AST or ALT or alkaline phosphatase > 2 x upper limit of normal) - Evidence of renal insufficiency (creatinine > 1.5 x upper limit of normal) - Patients with other clinically significant systemic diseases - Patients unable and/or unlikely to comprehend and follow the study procedures and instructions - Patients who have received any investigational drug during the preceding 30 days or 5 times the plasma half-life (if known), whichever is longer, or who have previously participated in this trial - Patients who are abusers of alcohol and/or other drugs - Patients who intend to donate blood or blood products during the study or within one month following the completion of the study - Patients with allergy, hypersensitivity or other medical contraindications to Vitamin D - History of disturbed calcium, phosphorus or magnesium metabolism
研究者
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