| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D899||Disorder involving the immune mechanism, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
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. |