Health Condition 1: N461- Oligospermia
Conditions
Interventions
Intervention1: CoQ10 Capsules all-natural Coenzyme Q10 with SOC: Patient will be asked to consume 1 capsule twice daily after breakfast and after dinner for total of 12 weeks duration along with SOC
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Sponsors
M/s Synthite Industries Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male participants aged 18 to 50 years 2 Diagnosis of oligospermia, confirmed by semen analysis showing a sperm concentration of less than 15 million sperm per milliliter or through medical history of the subjects 3 Willingness to provide informed consent to participate in the study 4 Ability to comply with the study protocol including attending study visits and completing study-related assessments. 5 Stable sexual partner or intention to engage in heterosexual intercourse for the duration of the study 6 Willingness to refrain from using other fertility treatments or supplements during the study period 7 Adequate understanding of the study procedures and willingness to follow the investigators instructions
Exclusion criteria
Exclusion criteria: 1. History and drug alcohol abuse smoking 2. BMI greater than 30 kg per m2 3. History of cancer chemotherapy 4. History of significant medical conditions that could affect fertility or interfere with study participation including severe cardiovascular disease uncontrolled hypertension renal failure liver disease or malignancy 5. Contraindication for the use of CoQ10 6. Genital disease (cryptorchidism current genital inflammation or varicocele) 7. Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) related illness and or known history of Hepatitis B virus (HBV) defined by presence of hepatitis B surface antigen (HBsAg) and or known history of Hepatitis C virus (HCV) defined by presence of hepatitis C antibody (HCVAb) 8. Genital trauma or surgery to the reproductive system 9. Hepatobiliary disease 10. Significant renal insufficiency 11. Occupational exposures to reproductive toxins 12. Endocrine abnormality 13. Recent or current sexually transmitted infection 14. Use of cytotoxic drugs 15. Use of immunosuppressants 16. Clinically relevant systemic disease (e g Insulin dependent diabetes adrenal dysfunction organic intracranial lesion, or hypothalamic tumor) or serious illness (Neoplasia) 17. Daunorubicin, Doxorubicin, Blood Pressure Medications Warfarin Timolol atorvastatin cerivastatin lovastatin pravastatin simvastatin gemfibrozil tricyclic antidepressant medications (including amitriptyline amoxapine clomipramine desipramine doxepin imipramine nortriptyline protriptyline and trimipramine) multivitamins or any vitamin supplementation except Folic acid 18.Use of anticonvulsants 19.Use of androgens or antiandrogens 20.History of central nervous system injury 21.Neurological or psychiatric disease to potentially compromise study data collection. 22.Abnormal COH screening blood done for both partners, including prolactin thyroid stimulating hormone prior to participation in study 23Treatment of erectile dysfunction with any drugs during the past 4 weeks 24 Current supplementation with ingredients being tested unless 1month washout period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Percent change in sperm count/concentration sperm motility fromTimepoint: 1 Screening to EOT at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Change in Hormonal Levels 2 Improvement in Total IIEF-EF score 3 Improvement in score of fertility quality of life questionnaire 4 Improvement in Male Sexual Health Questionnaire (MSHQ) ScoreTimepoint: 1 Baseline to EOT at week 12 2 baseline to EOT at week 12 3 Baseline to EOT at week 12 4 Baseline to EOT at week 12 | — |
Countries
India
Contacts
Public ContactMr Chandu Devanpally
Ardent Clinical Research Services
Outcome results
None listed