| CTRI Number |
CTRI/2024/06/068311 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Anti-aging protein and PSA in men with no sperm count in semen. |
|
Scientific Title of Study
|
Exploring Alpha-Klotho Protein and Prostate Specific Antigen Levels in Serum and Seminal Fluid in Azoospermic Men: A Case-Control Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naina Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bibinagar |
| Address |
Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Bibinagar.
All India Institute of Medical Sciences, Bibinagar, Hyderabad, Telangana.
Hyderabad
TELANGANA
508126
India |
| Phone |
9552515600 |
| Fax |
|
| Email |
drnainakumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Naina Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bibinagar |
| Address |
Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Bibinagar
All India Institute of Medical Sciences, Bibinagar, Hyderabad, Telangana.
TELANGANA
508126
India |
| Phone |
9552515600 |
| Fax |
|
| Email |
drnainakumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Naina Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bibinagar |
| Address |
Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Bibinagar
All India Institute of Medical Sciences, Bibinagar, Hyderabad, Telangana.
TELANGANA
508126
India |
| Phone |
9552515600 |
| Fax |
|
| Email |
drnainakumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bibinagar - 508126, Hyderabad, Telangana, India |
|
|
Primary Sponsor
|
| Name |
AIIMS Bibinagar |
| Address |
All India Institute of Medical Sciences Bibinagar 508126 Hyderabad Telangana India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Naina Kumar |
AIIMS, Bibinagar |
Department of Obstetrics and Gynecology, AIIMS, Bibinagar
Hyderabad
TELANGANA |
9552515600
drnainakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Bibinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL as it is an observational study |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess, evaluate, and compare the serum and seminal levels of α-Klotho protein in azoospermic and normozoospermic men,
2.To assess, evaluate, and compare the serum and seminal PSA levels in azoospermic and normozoospermic men,
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
|
| Outcome |
TimePoints |
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,
3.To develop effective diagnostic markers for early diagnosis of azoospermia. |
After finalization of results. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Infertility is a major issue nowadays with many couples all over the world
struggling with this problem. Furthermore, with the rise in the incidence of
male factor infertility globally, there is an increasing demand for better
predictors of male factor infertility and its treatment. The present study will be the first
of its kind that will also try to assess and evaluate the serum and seminal
levels of α-Klotho and PSA in azoospermic and normozoospermic men. Investigating
seminal and serum biomarkers like α-Klotho protein and PSA can help in
understanding the etiology of azoospermia, whether it’s related to testicular
dysfunction, obstructive factors, or other systemic issues. While PSA is a
well-established biomarker, α-Klotho protein is relatively newer in the context
of male infertility. Investigating α-Klotho protein levels in azoospermic men
may provide insights into its potential as a novel biomarker for reproductive
health. It can expand our knowledge of the molecular mechanisms involved in
spermatogenesis and fertility, potentially leading to the development of new
therapeutic targets or interventions. |