Health Condition 1: N461- Oligospermia
Conditions
Interventions
None listed
Sponsors
Gynoveda Femtech Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Sperm concentration less than 16 million per ml as per WHO Laboratory Manual for the Examination and Processing of Human Semen, Sixth Edition, 2021, 13, with or without normal sperm morphology, with or without normal total motility. 2. Subjects willing to give specimen of semen, ready to observe abstinence as per requirement of protocol, and willing to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects having azoospermia, or aspermia, or necrospermia. 2. Subjects with clinical diagnosis of Varicocele & Hydrocele (If required USG with color doppler of testes will be done to confirm the diagnosis) 3. Subjects with history of undescended testis. 4. Subjects with inguinal hernia or other clinical condition on physical examination which may have relation to low sperm count 5. Subjects with accessory gland infection 6. Known cases of Diabetes Mellitus Type 2 (DM2), Uncontrolled Hypertension (HTN), Uncontrolled Thyroid dysfunction, chronic kidney disease (CKD), Liver Cirrhosis, Cardiac Ailments, psychological disorders currently on medication, epilepsy (convulsions), STDs including HIV and Hepatitis B 7. Presence of pus cells in semen (Pyospermia), absence of fructose in semen and Semen liquefaction time greater than 30 minutes, history of testicular or scrotal tumours, cysts, or obstruction 8. Subjects with severe form of sexual dysfunction and history of presence of significant alcoholism or drug abuse within the past 1 year and significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products more than 10 times per day. 9. Subjects who underwent surgery within last 4 weeks or planned major surgery within next 120 days from the date of screening and subjects who have participated in any drug research study within past 3 months. 10. History of allergic reaction to any of the drug component. 11. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in sperm count and motilityTimepoint: Screening Visit (Up to 5 days), Baseline visit (Day 0), Visit 1, (Day 30), Visit 2 (Day 60), Visit 3 (Day 90), Visit 4 (Day 120) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in sperm morphology, erectile function, sexual desire, energy levels 2. Assessment of premature ejaculation 3. Changes in hormonal regulation of spermatogenesis 4. Spontaneous achieved pregnancies 5. Adverse events and vitals and laboratory investigations Timepoint: Screening Visit (Up to 5 days), Baseline visit (Day 0), Visit 1, (Day 30), Visit 2 (Day 60), Visit 3 (Day 90), Visit 4 (Day 120) | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed