| CTRI Number |
CTRI/2019/11/022176 [Registered on: 27/11/2019] Trial Registered Prospectively |
| Last Modified On: |
06/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the usefulness of two different tests done on uterine lining to help in diagnosing female genital tuberculosis |
|
Scientific Title of Study
|
A Retrospective study to evaluate the diagnostic capability of Gene Xpert MTB / RIF and Mycoreal polymerase chain reaction (PCR) techniques in the diagnosis of female genital tuberculosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ASHWINI M |
| Designation |
SENIOR CONSULTANT 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 |
ashwinmash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHWINI M |
| Designation |
SENIOR CONSULTANT 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 |
ashwinmash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ASHWINI M |
| Designation |
SENIOR CONSULTANT 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 |
ashwinmash@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, Basavanagudi, 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 ASHWINI M |
Gunasheela Surgical and Maternity Hospital |
Department of Reproductive Medicine,
No.1 Dewan N. Madhava Rao Road, Basavanagudi
Bangalore
KARNATAKA |
9902204111
ashwinmash@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: N711||Chronic inflammatory disease of uterus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) Unexplained infertility
2) Recurrent implantation failure
3) Recurrent pregnancy loss
4) Tubal factor
5) Uterine factors such as : Thin/pale endometrium, ashermans syndrome . |
|
| ExclusionCriteria |
| Details |
1) Ovulatory dysfunction
2) Endometriosis.
3) Other uterine factors such as fibroid, polyp, adenomyosis, congenital uterine malformations.
4) Male factor.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity, specificity and diagnosis of genital tuberculosis |
Cross sectional study, only once sample will be collected from patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Cross sectional study, only once sample will be collected from patients |
|
|
Target Sample Size
|
Total Sample Size="3400"
Sample Size from India="3400"
Final Enrollment numbers achieved (Total)= "3229"
Final Enrollment numbers achieved (India)="3229" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2019 |
| Date of Study Completion (India) |
06/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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: This is a Retrospective study to evaluate the diagnostic capability of gene expert and mycoreal PCR techniques in diagnosis of female genital tuberculosis considering culture as gold standard. Patients who attended the OPD between Jan 2013 and January 2017, satisfying the eligbility criteria, will be included in the study. Patients were subjected to endometrial pipelle sampling premenstrually (b/w Day 21- Day 24 of cycle) on OPD basis. Endometrial samples were tested for TB PCR and BACTEC culture. The Sensitivity, Specificity and Accuracy will be calculated. |