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CTRI Number  CTRI/2019/12/022207 [Registered on: 02/12/2019] Trial Registered Prospectively
Last Modified On: 27/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study to know whether blood sample is as good as uterine lining sample for measuring natural killer cells 
Scientific Title of Study   Retrospective study on peripheral blood natural killer(pNK) cells as surrogate measure for uterine natural killer(uNK) cells 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SHILPA GUPTA KS 
Designation  MBBS. MS OBG. DNB. FELLOW IN REPRODUCTIVE MEDICINE  
Affiliation  Gunasheela Surgical and Maternity Hospital 
Address  Department of Reproductive Medicine, No 1, Dewan N. Madhava Rao Road, Basavanagudi

Bangalore
KARNATAKA
560004
India 
Phone  08046462600  
Fax    
Email  drshilpagupta22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SHILPA GUPTA K S 
Designation  MBBS. MS OBG. DNB. FELLOW IN REPRODUCTIVE MEDICINE  
Affiliation  Gunasheela Surgical and Maternity Hospital 
Address  Department of Reproductive Medicine, No 1, Dewan N. Madhava Rao Road, Basavanagudi

Bangalore
KARNATAKA
560004
India 
Phone  08046462600  
Fax    
Email  drshilpagupta22@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SHILPA GUPTA KS 
Designation  MBBS. MS OBG. DNB. FELLOW IN REPRODUCTIVE MEDICINE  
Affiliation  Gunasheela Surgical and Maternity Hospital 
Address  Department of Reproductive Medicine, No 1, Dewan N. Madhava Rao Road, Basavanagudi

Bangalore
KARNATAKA
560004
India 
Phone  08046462600  
Fax    
Email  drshilpagupta22@gmail.com  
 
Source of Monetary or Material Support  
Gunasheela Surgical and Maternity Hospital, No.1, Dewan N. Madhava Rao Road, Basavanagudi, Bangalore - 560 004 
 
Primary Sponsor  
Name  Gunasheela Surgical and Maternity Hospital 
Address  Dewan N Madhava Rao Road, Basavangudi, Bangalore 560 004 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SHILPA GUPTA KS  Gunasheela Surgical and Maternity Hospital  Department of Reproductive Medicine, No.1 Dewan N. Madhava Rao Road, Basavanagudi
Bangalore
KARNATAKA 
7639417687

drshilpagupta22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Gunasheela Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D899||Disorder involving the immune mechanism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  28.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Infertile women of ages 28 to 35 years who had
2. History of two or more abortions
3. History of recurrent implantation failure (failure to achieve a clinical pregnancy after transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles in a woman)
 
 
ExclusionCriteria 
Details  1. Women with irregular cycle
2. Women on Oral contraceptive pills
3. Women with Antiphospholipid antibody syndrome
(APLA) positive
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
pNK and uNK cell  Cross sectional study, only once sample will be collected from infertile women 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  Cross sectional study, only once sample will be collected from infertile women 
 
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)   02/12/2019 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Will be published in suitable journal 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Summary :

Natural killer cells are one of the major components of the innate immune system. The natural killer cells are present in peripheral blood as well as in some target organs like spleen, liver, uterus etc. Uterine natural killer cells secrete many cytokines and growth factors which may play a role in implantation. Alteration in the number of uterine natural killer cells subset has been suggested as a cause for recurrent miscarriage as well as implantation failure. Measurement of uterine natural killer cells is technologically challenging and requires invasive endometrial biopsy.

The purpose of this study was to find out whether there is any correlation between the number peripheral blood NK cells and the number of uterine NK cells, so that the results of measuring the peripheral blood natural killer cells can be extrapolated to the uterine natural killer cells thereby avoiding the invasive testing.

We will be doing a retrospective analysis of the hospital records between May 2017 to October 2017.  Infertile patients between ages 25 to 38years who have undergone measurement of peripheral blood and uterine natural killer cells will be included.  Women with previous history of abortion or recurrent implantation failure will be included in this study. Women with irregular cycles, women with antiphospholipid antibody syndrome and who were on oral contraceptive pills will be excluded. The patients included had undergone both the peripheral blood and uterine (endometrial) sample on the same day in the mid luteal phase of menstrual cycle(Day 22 to Day 26 of menstrual cycle). The percentage of CD 56 bright and CD 16 dim as well as CD 56 dim and CD 16 bright in the samples were analyzed by flow cytometry.

By this study we will know whether there is a correlation between the number of peripheral and uterine NK cells in the secretory phase and if there is a correlation we can avoid the invasive uterine biopsy.

 
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