| CTRI Number |
CTRI/2024/05/067437 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of soluble human leukocyte antigen as marker of embryo quality for clinical outcomes in women undergoing IVF/ICSI cycles |
|
Scientific Title of Study
|
Use of soluble human leukocyte antigen (sHLA-G) as potential biomarker of embryo quality for clinical outcomes in women undergoing IVF/ICSI non-donor cycles – A Prospective Observational 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 |
Dr. Nisha |
| Designation |
Resident |
| Affiliation |
AIIMS,NEW DELHI |
| Address |
Room 3, ART center, Mother and Child Block, All India Institute of Medical Science , New Delhi
South
DELHI
110029
India |
| Phone |
8606189624 |
| Fax |
|
| Email |
nisharao.gudiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Singh |
| Designation |
Professor |
| Affiliation |
AIIMS,NEW DELHI |
| Address |
Room 709, Mother and Child Block, All India Institute of Medical Science, New Delhi
South
DELHI
110049
India |
| Phone |
9818506855 |
| Fax |
|
| Email |
drneetasingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nisha |
| Designation |
Resident |
| Affiliation |
AIIMS,NEW DELHI |
| Address |
Room 1, ART Centre, Mother and Child Block, All India Institute of Medical Science, New Delhi
South
DELHI
110029
India |
| Phone |
8606189624 |
| Fax |
|
| Email |
nisharao.gudiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research Section, All India Institute of Medical Science, New Delhi, Pin Code: 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Science |
| Address |
Research Section, All India Institute of Medical Science, New Delhi, Pin Code: 110049 |
| 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 Science |
Room 1, ART centre, Department of Obstetrics and Gynaecology, All India Institute of Medical Science, New Delhi, Pin Code:110029
South
DELHI |
8606189624
nisharao.gudiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee for post graduate research, All India Institute of Medical Sciences, Ansari Nagar, 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 |
38.00 Year(s) |
| Gender |
Female |
| Details |
normo/hyper-responders, tubal factor, endometriosis, mild male factor infertility |
|
| ExclusionCriteria |
| Details |
oncofertility patients, donor recipient cycles, diminished ovarian reserve, male factor infertility, |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing influence of sHLA-G on Day-3 embryo quality |
Day 3 Embryo quality |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluating the quantitative analysis of sHLA-G in relation to the quality of embryos on Day 3, evaluating the quantitative analysis of sHLA-G in relation to the quality of embryos on Day 5, Evaluating the influence of sHLA-G on implantation rate, clinical pregnancy rate & on ongoing pregnancy rate |
Day 3 embryo quality, day 5 embryo quality, after 2weeks of embryo transfer, at 6weeks of pregnancy |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/06/2024 |
| 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 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
|
In this study soluble human leukocyte antigen will be assessed from day 3 spent culture media. depend on its value embryo quality will be assessed and embryo transfer will be performed accordingly. in this study we want assess whether soluble human leukocyte antigen is a potential maker for embryo quality. Study is not yet started. |