“A Randomized, Double Blind, Placebo Controlled, Multi-center, Parallel Group, Clinical Study to Evaluate Efficacy and Safety of “TLPL/AY/04/2009†in Patients Suffering from Male Infertility.â€
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Changes in total sperm count
研究概览
简要总结
Thiswill be a randomized, double blind, placebocontrolled, multi-center, parallel group, clinical study to evaluate efficacyand safety of “TLPL/AY/04/2009†in patients suffering from Male Infertility. Thetrial will be conducted at three different sites in India. A total of 50subjects suffering from male infertility will be recruited in the trial to get40 evaluable cases (20 subjects in drug group and 20 subjects in placebo group)at the end of the trial. Asper computer generated randomization list, subjects will be advised to consume givenmedication (either Capsule TLPL/AY/04/2009 or Capsule Placebo) in a dose of 2 capsulestwice daily orally after meals with a cup of milk for 4 months. Theprimary objective of the trial will be post treatment changes in total spermcount. The secondary objectives will be post treatment changes in semen volume,sperm motility with progressive sperm motility, total number of spermatozoa perejaculate, sperm morphology, viability of spermatozoa, serum levels of totaland free testosterone, serum level of LH (luteinizing hormone) and FSH(follicle stimulating hormone). Secondary objectives of the trial also includenumber of spontaneous achieved pregnancies at the end of the trial, posttreatment global assessment for overall improvement by the patient, globalassessment for overall improvement by the investigator, tolerability of study drugs byassessing ADRs on study completion and post treatment changes in laboratoryparameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Married male subjects between 21 to 45 years of age.
- •Subjects with the history of minimum 1 year of regular unprotected sexual activity without achieving pregnancy.
- •Subject having Sperm concentration (sperm count; sperm/ml) < 15 millions/ml.
- •Subject having semen volume (total volume of ejaculate) not to be < 1.5 ml per ejaculate,
- •Subject with or without Sperm total motility less than 40% or sperm forward progressive motility less than 32%.
- •Subject having Normal sperm morphology.
- •Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
排除标准
- •Subjects with abnormal laboratory investigation(s) (above or below normal range) with corresponding clinical symptoms will not be recruited in the trial.
- •Subjects demonstrating hemospremia, leucospermia, absence of fructose or pH < 7.2 or > 8.0 hyperspermia i.e. > 7 ml ejaculatory volume.
- •Subjects having Klinefelter’s Syndrome, Kartagener Syndrome.
- •Congenital anomalies – spine bifida, congenital bilateral/unilateral absence of vas deference.
- •Subject whose ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
- •Subject whose X- ray chest showing any active lesion of Tuberculosis.
- •Subject whose USG and/or colour Doppler of testes showing hydrocele, varicocele, orchitis, and epididymitis or any other abnormal findings, will not be recruited in the trial.
- •Subjects showing high serum prolactin levels will not be recruited in the trial.
- •Subjects having active metabolic or gastrointestinal diseases or any kind of physical anamoli that may interfere with spermatogenetic process or pathway.
- •Subject having drug dependency or failure to keep abstinence for antioxidant agents, vitamins, anti-inflammatory drugs, hormones, herbal /homeopathic medications.
- •Subject with abuse like smoking, alcohol etc.
- •Subjects having known hepatic or renal disease.
- •Subjects having an active malignancy.
- •Subjects having untreated/uncontrolled hypertension.
- •Subjects having Diabetes Mellitus.
- •Subjects having chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •Known hypersensitivity to ingredients used in study drug.
- •Children and women will not be recruited in this study.
- •Occurrence of febrile illness, Temperature > 102 oF within 3 months prior screening.
- •Body Mass Index (BMI) > 35 kg/m
- •Subjects who have occupational / environmental exposures to risk factors for male reproductive System, e.g. chronic heat exposure, ionizing radiation, heavy metals like lead, cadmium, certain pesticides, frequent sauna bath etc.
结局指标
主要结局
Changes in total sperm count
时间窗: Screening visit (Day -7), Day 0, Day 90 and Day 120
次要结局
- 1.Changes in semen volume, Sperm motility with progressive sperm motility, total number of spermatozoa per ejaculate, Sperm Morphology, viability of spermatozoa,serum levels of total and free testosterone, serum level of prolactin, LH and FSH,(2.Changes in the number of spontaneous achieved pregnancies.)