| CTRI Number |
CTRI/2026/01/102400 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of higher male age on semen quality and pregnancy outcome in couples undergoing intrauterine insemination (IUI) |
|
Scientific Title of Study
|
Impact of advanced paternal age on semen quality and reproductive outcomes of intrauterine insemination in infertile couples |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Blessey viji Samuel |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of Clinical Embryology
G block No 6 Reddamma apartments 237/47 Arcot road Virugambakkam chennai-600092
Chennai
TAMIL NADU
600092
India |
| Phone |
9840873445 |
| Fax |
|
| Email |
blesseysamuel2003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Sharma S |
| Designation |
Professor |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of Clinical Embryology
No 162, Poonamallee High Road, Chennai - 600 077
Chennai
TAMIL NADU
600077
India |
| Phone |
9445560392 |
| Fax |
91-44-26800892 |
| Email |
nidhisharma.smc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Sharma S |
| Designation |
Professor |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of clinical Embryology
No 162, Poonamallee High Road, Chennai - 600 077
Chennai
TAMIL NADU
600077
India |
| Phone |
9445560392 |
| Fax |
91-44-26800892 |
| Email |
nidhisharma.smc@saveetha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Saveetha Institute of Medical and Technical Sciences
Saveetha Nagar, Thandalam, Chennai- 602105 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Nidhi Sharma S |
Saveetha Institute of Medical and Technical Sciences |
Department of clinical Embryology
Saveetha Nagar, Thandalam, Chennai – 602105
Chennai
TAMIL NADU |
94455 60392
91-44-26800892
nidhisharma.smc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific Review Board Saveetha Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O073||Failed attempted termination of pregnancy with other and unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
26.00 Year(s) |
| Age To |
47.00 Year(s) |
| Gender |
Both |
| Details |
1. Male partner lesser than fifty years
2. One or more IUI cycles
3. Female partner lesser than forty five years
4. Willingness to provide informed consent
5. Female partner with patent fallopian tubes |
|
| ExclusionCriteria |
| Details |
1. Male partner greater than or equal to 50 years
2. Female partner age greater than or equal to 45 years
3. Azoospermia men and Severeoligoasthenoteratozoospermia (SOAT)
4. Severe female factor infertility(e.g., bilateral tubal blockage, severe endometriosis)
5. IUI involving donor oocytes
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Semen quality parameters and clinical pregnancy rate following intrauterine insemination |
At baseline (at time of semen analysis before IUI) and clinical pregnancy assessment 4–6 weeks after intrauterine insemination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
08/02/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is a prospective observational study designed to evaluate the impact of advanced paternal age on semen quality and reproductive outcomes of intrauterine insemination in infertile couples. A total of fifty infertile couples undergoing intrauterine insemination will be enrolled. Male partners will be categorized based on age and semen parameters including sperm concentration motility and morphology will be assessed according to World Health Organization guidelines. Reproductive outcomes such as biochemical pregnancy and clinical pregnancy following intrauterine insemination will be evaluated. The study aims to determine the association between paternal age semen quality and intrauterine insemination outcome. |