| CTRI Number |
CTRI/2024/08/073079 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of lifestyle factors on sperm quality in couples who are unable to concieve: - Cross-sectional Study |
|
Scientific Title of Study
|
Effect Of Modifiable Lifestyle Factors On Sperm Quality In Male Seeking For Infertility Treatment: - Cross-sectional Study |
| Trial Acronym |
not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neeta Singh |
| Designation |
Professor |
| Affiliation |
All India Institute of medical Sciences, New Delhi |
| Address |
Room 709, Mother and child block, Department of obstetrics and gynaecology, All India Institute of medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
98185056855 |
| Fax |
|
| Email |
drneetasingh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha |
| Designation |
Resident |
| Affiliation |
All India Institute of medical Sciences, New Delhi |
| Address |
Room 3,ART centre Mother and child block, Department of obstetrics and gynaecology, All India Institute of medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
8606189624 |
| Fax |
|
| Email |
nisharao.gudiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha |
| Designation |
Resident |
| Affiliation |
All India Institute of medical Sciences, New Delhi |
| Address |
Room 3,ART centre Mother and child block, Department of obstetrics and gynaecology, All India Institute of medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
8606189624 |
| Fax |
|
| Email |
nisharao.gudiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
Research Section, 1st floor, Academic block, All India Institute of Medical Sciences, New Delhi |
| 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 |
| Dr Nisha |
All India Institute of medical Sciences, New Delhi |
Room 3, ART Centre, Department of obstetrics and gynaecology, Mother and Child block, All India Institute of Medical Sciences, New Delhi
South
DELHI |
8606189624
nisharao.gudiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
INFERTILITY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Male |
| Details |
Men who are unable to conceive after 12 months of regular unprotected intercourse |
|
| ExclusionCriteria |
| Details |
any history of systemic diseases, any history of chemotherapy, radiotherapy or malignancy, not able to give sample, not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of smart phones on semen quality |
To assess the effect of smart phones on semen quality at 1st visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess thr effect of smoking, alcohol, tobacco, caffeine, occupation, clothing, hot water shower, radiation exposure, sleep & obesity on semen quality |
semen analysis at 1st visit |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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)
|
23/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/09/2024 |
| 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
|
It is a cross-sectional study to assess effect of modifiable lifestyle factors on semen quality at 1st visit. Recruitments for this study is not yet started. |