| CTRI Number |
CTRI/2024/10/075862 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of anthropometric parameters, lipid profile and hormone profile of infertile men on semen parameters |
|
Scientific Title of Study
|
Correlation of anthropometric parameters, lipid profile and hormone profile of infertile men with semen parameters: A prospective cohort 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 |
Neeta Singh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 709, Department of Obstetrics and Gynaecology, Mother and Child Block, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9818506855 |
| Fax |
|
| Email |
drneetasingh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Supriya |
| Designation |
Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 3, ART centre, Department of Obstetrics and Gynaecology, Mother and Child Block, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
8249371093 |
| Fax |
|
| Email |
mdcdtsupriya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Supriya |
| Designation |
Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 3, ART centre, Department of Obstetrics and Gynaecology, Mother and Child Block, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
8249371093 |
| Fax |
|
| Email |
mdcdtsupriya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and gynaecology, All India Institute of Medical Sciences, New Delhi, Pin code 110029 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 Supriya Kumari |
All India Institute of Medical Sciences, New Delhi |
Room 709, Seventh floor, MCB, Department of obstetrics and gynaecology, AIIMS, New Delhi
South
DELHI |
8249371093
mdcdtsupriya@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 |
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 with subfertility undergoing treatment at AIIMS planned for semen analysis |
|
| ExclusionCriteria |
| Details |
Men who were undergoing treatment for dyslipidemia, any history of mumps/measles in childhood, bariatric surgery, erectile dysfunction and any history of chemo/radiotherapy
|
|
|
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 anthropometric parameters on semen quality |
At first visit in hospital |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The effect of Serum LH, FSH, testosterone, prolactin, inhibin on semen quality
|
At second visit in hospital |
|
|
Target Sample Size
|
Total Sample Size="275"
Sample Size from India="275"
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)
|
29/11/2024 |
| 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 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
|
Increased weight has been at the cornerstone of female infertility since ages. However, not much weightage has been given to male infertility and factors affecting it. Among those factors, one of the important things to be considered is male weight, anthropometric parameters, and its effect on abnormal semen parameters. To further examine these issues we analyzed the relations of body weight with standard semen analysis parameters, sperm DNA integrity, and serum levels of reproductive hormones in a group of men presenting with their partners for evaluation of infertility. |