CTRI/2011/09/001995招募中2 期
Effect of Semenax on semen characteristics with Protocol ID: DM/100710/SMX/MSD
eading Edge Marketing0 个研究点目标入组 96 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
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
入选标准
- •Men with hypospermia (semen volume lower than 2ml) or normospermia (semen volume 2-5.5ml) on at least two semen analyses)
- •Men with normozoospermia (sperm concentration 20x106 /ml
- •Men with mild oligospermia (sperm concentration10-19.99x106/ml or moderate oligospermia (sperm concentration 4-10x106/ml)
- •Men with normal to subnormal levels of sperm motility and sperm morphology
- •Men willing to maintain a consistent abstinence period of 2 to 7 days each time before producing semen samples and comply with other semen collection procedures
排除标准
- •1.Aspermia (no semen)
- •2.Absence of Fructose /low fructose (13 µmol per ejaculate)
- •3.ph7.2 or 8.0
- •4.Presence of red blood cells (hemospermia)
- •5.Excessive leucocytes or leucospermia (peroxidase positive cells1x106 /ml)
- •6.Severe impairment of ejaculate volume or sperm concentration or sperm motility or sperm morphology
- •7.Ejaculate volume5.5 ml (Includes hyperspermia i.e 7 ml of ejaculate volume)
- •8.Moderate impairment occurring in more than two sperm parameters: sperm concentration, sperm morphology and sperm motility
- •9.Neurological disorders such as multiple sclerosis, , demyelization disease, tumors, degenerative conditions etc
- •10.Presence of diabetic neuropathy or complications, use of insulin for glycemic control, duration of diabetes over five years from detection
- •11.Untreated or uncontrolled hypertension
- •12.Inflammatory disorders, infections or obstruction of the genital tract
- •13.Congenital anomalies (spina bifida, spinal dysraphism , congenital bilateral/ unilateral absence of the vas deferens )
- •14.History of trauma to the pelvic organs or spinal cord injury
- •15.Surgical history of radical prostatectomy, retroperitoneal lymphadenectomy, bladder neck surgery, pelvic surgery, spinal cord surgery, vasectomy
- •16. History of mumps orchitis within 3 years of screening
- •17.History of Cryptorchidism
- •18.Complete absence of ejaculation (anejaclation), anorgasmia or dysorgasmia
- •19.Known or suspected cases of.Klinefelter?s syndrome or Kartagener?s syndrome
- •20.Clinical suspicion of benign prostratic hyperplasia or varicocele
- •21.Recent history of a major systemic illness
- •22.Occurrence of febrile illness (temperature over 102º F) within 3 months before screening/ semen sample collection
- •23.Drug exposure known to affect sperm characteristics, within three months of the first semen analysis. (Refer list of prohibited medications)
- •24.Illnesses (including psychiatric illnesses) that received (within one month of screening) or require treatment with drugs known to affect sexual function (Refer list of prohibited medications)
- •25.Known cases of HIV ,AIDS or recent cases of sexually transmitted diseases
- •26.Infertility treatment or assisted reproductive procedures
- •27.Clinically significant laboratory abnormality at screening
- •28.Any other condition which in the opinion of the investigator may affect the evaluations of the study
- •29.BMI 30 kg/m2
- •30.Moderate to heavy alcohol consumption (more than 40 to 80 grams/ 3.5 to 7 standard drinks, per day)
- •31. Excessive smoking (more than 10 cigarettes per day)
- •32.Substance abuse (eg heroin, methadone, marijuana etc)
- •33.Occupational or environmental exposure to risk factors for male reproductive system (eg. Chronic exposure to heat, ionizing radiation, heavy metals like lead cadmium, certain pesticides like dibromochloropropane, aromatic solvents, driving for prolonged intervals, frequent sauna baths etc)
- •34.Participation in a clinical study 2 months prior to screening
- •35.Known hy
研究者
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