Health Condition 1: N461- Oligospermia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Sperm count less than 15 million per ml, Total motility less than 40 percent and Progressive motility less than 32 percent 2. In the opinion of the investigator, patients able and willing to comply with all trial requirements 3 Patients willing to sign informed consent to enroll in the study
Exclusion criteria
Exclusion criteria: 1. Azoospermia 2. Aspermia 3. Necrospermia 4. Known case of or clinical diagnosis of testicular varicocele and hydrocele 5. Known case of Filariasis 6. Diabetes mellitus 7. Undescended testis 8. Male accessory gland infection 9. Inguinal hernia on physical examination 10. History of any other chronic illness 11. Underwent treatment for promoting spermatogenetic fertility in last 3 months. 12. Participants who have participated in another research trial involving an investigational product in the past 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the sperm concentration will be assessedTimepoint: at baseline, at end point (Day 91) and after follow up (Day 181) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in percentage of total & progressive motility & the percentage of normal forms of sperm will be assessed by semen analysis 2. Changes in sperm DNA fragmentation index will be assessed in a subgroup of patients (10 percent of total sample size) 3. Changes in the titre of anti-sperm antibodies will be assessed in a subgroup of patients (10 percent of total sample size) 4. Changes in Serum Testosterone FSH & LH hormone levels will be recorded by blood testTimepoint: at baseline, at end point (Day 91) & after follow up (Day 181) | — |
Countries
India
Contacts
National Institute of Siddha