| CTRI Number |
CTRI/2018/03/012420 [Registered on: 08/03/2018] Trial Registered Prospectively |
| Last Modified On: |
16/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
analysis of semen parameters of couples attending infertility clinic |
|
Scientific Title of Study
|
To assess the semen parameters of sub fertile couples at a tertiary level fertility clinic |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Disha shree B S |
| Designation |
junior resident |
| Affiliation |
KMC, Manipal |
| Address |
Department of OBG, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008208432 |
| Fax |
|
| Email |
disha1027@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aswathy Kumaran |
| Designation |
Assistant Professor |
| Affiliation |
KMC, Manipal |
| Address |
Department of OBG, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9599874859 |
| Fax |
|
| Email |
astra117us@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Disha shree B S |
| Designation |
junior resident |
| Affiliation |
KMC, Manipal |
| Address |
Department of OBG, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008208432 |
| Fax |
|
| Email |
disha1027@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba hospital, Madhav nagar, manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Disha shree B S |
| Address |
#45,soniya hostel, Kasturba medical college, manipal |
| 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 Disha shree B S |
Kasturba hospital manipal |
Department of OBG, Kmc manipal
Udupi
KARNATAKA |
9008208432
disha1027@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Male partners of Sub fertile couple, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Best semen analysis report of all male partners of sub fertile couples attending MARC |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The percentage of human semen analysis(HSA) reports that fell below the 5th centile of WHO 2010 reference values will be noted to analyse the prevalence of HSA based male subfertility.The 5th, 50th, 75th and 95th centile semen analysis values for the male partners of subfertile couples will be noted and compared with the WHO 2010 reference values for fertile men. The conception rates and methods used based on both the reference values will be assessed. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="768" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/03/2018 |
| Date of Study Completion (India) |
30/10/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a prospective analytical study in which the best semen analysis reports of all male partners of subfertile couples attending a tertiary level fertility clinic will be analysed over a period of one year to get a percentile plot or distribution which will then be compared with the WHO 2010 reference values in centile.The percentage of human semen analysis reports that fell below the 5th centile of WHO reference values will be noted to analyse the prevalence of human semen analysis based male subfertilily,The 5th, 50th, 75th and 95th centile values in the semen analysis report will be noted and compared with the WHO 2010 reference values for fertile men.conception rates of the recruited couple will be assessed.prewash and postwash sperm concentration and progressive motility will be noted . |