Role of Anti-aging protein and PSA in men with no sperm count in semen.

Not yet recruiting

• Conditions: Diseases of the genitourinary system,

• Registration Number: CTRI/2024/06/068311
• Lead Sponsor: AIIMS Bibinagar

Brief Summary

Infertility is a major issue nowadays with many couples all over the worldstruggling with this problem. Furthermore, with the rise in the incidence ofmale factor infertility globally, there is an increasing demand for betterpredictors of male factor infertility and its treatment. The present study will be the firstof its kind that will also try to assess and evaluate the serum and seminallevels of α-Klotho and PSA in azoospermic and normozoospermic men. Investigatingseminal and serum biomarkers like α-Klotho protein and PSA can help inunderstanding the etiology of azoospermia, whether it’s related to testiculardysfunction, obstructive factors, or other systemic issues. While PSA is awell-established biomarker, α-Klotho protein is relatively newer in the contextof male infertility. Investigating α-Klotho protein levels in azoospermic menmay provide insights into its potential as a novel biomarker for reproductivehealth. It can expand our knowledge of the molecular mechanisms involved inspermatogenesis and fertility, potentially leading to the development of newtherapeutic targets or interventions.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-05-31
• Study Start: 2024-06-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

All azoospermic male partners of infertile couples between ≥21-50 years of age and married for ≥1 year reporting to the infertility clinic will be enrolled as cases and all normozoospermic fertile men (≥21-50 years) having one or more biological children will be enrolled as controls.

Exclusion Criteria

Renal/cardiovascular/liver diseases Diabetes mellitus Alzheimer disease Osteoporosis Hypoparathyroidism Prostate or testicular cancers Rheumatoid arthritis Inflammatory bowel disease Radiotherapy, chemotherapy Semen abnormalities other than azoospermia.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To assess, evaluate, and compare the serum and seminal levels of α-Klotho protein in azoospermic and normozoospermic men,	During second visit.
2.To assess, evaluate, and compare the serum and seminal PSA levels in azoospermic and normozoospermic men,	During second visit.
3.To establish the correlation between α-Klotho and PSA levels in semen and serum of azoospermic and normozoospermic men.	During second visit.

Secondary Outcome Measures

Name	Time	Method
1.To explore the potential involvement of α-Klotho protein in the process of spermatogenesis,	2.To develop targeted treatment options for men with azoospermia,

Trial Locations

Locations (1)

AIIMS, Bibinagar; 🇮🇳 Hyderabad, TELANGANA, India

AIIMS, Bibinagar

🇮🇳Hyderabad, TELANGANA, India

Naina Kumar

Principal investigator

9552515600

drnainakumar@gmail.com