CTRI/2024/06/068939Not yet recruitingUnknown
A Prospective Interventional Open label Single-centre Single arm Study to Evaluate the Efficacy and Safety of CoQ10 Capsules in Subject suffering with Oligospermia - NI
M/s Synthite Industries Private Limited0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
Investigators
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