A clinical study to evaluate efficacy and safety of â??TLPL/AY/04/2009â?? in comparison with placebo in patients suffering from Male Infertility.
- Conditions
- Health Condition 1: null- Male Infertility
- Registration Number
- CTRI/2012/09/002950
- Lead Sponsor
- Tulip Lab Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1. Married male subjects between 21 to 45 years of age.
2. Subjects with the history of minimum 1 year of regular unprotected sexual activity without achieving pregnancy.
3. Subject having Sperm concentration (sperm count; sperm/ml) < 15 millions/ml.
4. Subject having semen volume (total volume of ejaculate) not to be < 1.5 ml per ejaculate,
5. Subject with or without Sperm total motility less than 40% or sperm forward progressive motility less than 32%.
6. Subject having Normal sperm morphology.
7. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
1. Subjects with abnormal laboratory investigation(s) (above or below normal range) with corresponding clinical symptoms will not be recruited in the trial.
2. Subjects demonstrating hemospremia, leucospermia, absence of fructose or pH < 7.2 or > 8.0 hyperspermia i.e. > 7 ml ejaculatory volume.
3. Subjects having Klinefelterâ??s Syndrome, Kartagener Syndrome.
4. Congenital anomalies â?? spine bifida, congenital bilateral/unilateral absence of vas deference.
5. Subject whose ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
6. Subject whose X- ray chest showing any active lesion of Tuberculosis.
7. 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.
8. Subjects showing high serum prolactin levels will not be recruited in the trial.
9. Subjects having active metabolic or gastrointestinal diseases or any kind of physical anamoli that may interfere with spermatogenetic process or pathway.
10. Subject having drug dependency or failure to keep abstinence for antioxidant agents, vitamins, anti-inflammatory drugs, hormones, herbal /homeopathic medications.
11. Subject with abuse like smoking, alcohol etc.
12. Subjects having known hepatic or renal disease.
13. Subjects having an active malignancy.
14. Subjects having untreated/uncontrolled hypertension.
15. Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
16. Subjects having Diabetes Mellitus.
17. Subjects having chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
18. Known hypersensitivity to ingredients used in study drug.
19. Children and women will not be recruited in this study.
20. Occurrence of febrile illness, Temperature > 102 oF within 3 months prior screening.
21. Body Mass Index (BMI) > 35 kg/m2.
22. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in total sperm countTimepoint: Screening visit (Day -7), Day 0, Day 90 and Day 120
- Secondary Outcome Measures
Name Time Method 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, <br/ ><br>2.Changes in the number of spontaneous achieved pregnancies. <br/ ><br>3.Global assessment for overall improvement by the patient and by the Investigator <br/ ><br>4.Tolerability of study drugs <br/ ><br>5. Changes in Laboratory parametersTimepoint: Screening visit (Day -7), Day 0, Day 90 and Day 120