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CTRI Number  CTRI/2025/08/092834 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Prediction of infection in women not conceiving 
Scientific Title of Study   Evaluation of predictive value of newer scoring system SHUDE SCORE for chronic endometritis in women with previous reproductive failure undergoing IVF treatment. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHUCHI JAIN 
Designation  Professor and Head 
Affiliation  Mahatma Gandhi Institute of Medical Sciences, Sevagram 
Address  Dept of Obsteterics & Gynecology, Mahatma Gandhi Institute of Medical Sciences, Sevagram

Wardha
MAHARASHTRA
442102
India 
Phone  9422141337  
Fax  07152 284333  
Email  shuchimjain@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Deepti Shrivastava 
Designation  Professor 
Affiliation  Datta Meghe Institute of Medical Sciences 
Address  Dept of Obsteterics & Gynecology, Datta Meghe Institute of Medical Sciences

Wardha
MAHARASHTRA
442001
India 
Phone  8830818640  
Fax    
Email  deepti_shrivastava@gmail.com  
 
Details of Contact Person
Public Query  
Name  Deepti Shrivastava 
Designation  Professor 
Affiliation  Datta Meghe Institute of Medical Sciences 
Address  Dept of Obsteterics & Gynecology, Datta Meghe Institute of Medical Sciences

Wardha
MAHARASHTRA
442001
India 
Phone  8830818640  
Fax    
Email  deepti_shrivastava@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Shuchi JAIN 
Address  Dept of Obsteterics & Gynecology,Mahatama Gandhi Institute of Medical Sciences, Wardha MAHARASHTRA 442102 India  
Type of Sponsor  Other [self financed] 
 
Details of Secondary Sponsor  
Name  Address 
Dean  Dept of pathology.mahatama gandhi Institute of Medical Sciences, Wardha MAHARASHTRA 442102 India  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Deepti Shrivastava  Datta Meghe Institute of medical sciences, Wardha  Department of Obstetrics & Gynecology, IVF lab
Wardha
MAHARASHTRA 		 08830818640

deepti_shrivastava@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Medical Sciences Sevagram Institutional Ethics Committee For Research on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N711||Chronic inflammatory disease of uterus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  (1) a history of previous implantation failure after IVF or previous pregnancy loss.
(2) normal hysterosalpingography
(3) normal chromosomal karyotype
(4) normal thyroid function test and prolactin
 
 
ExclusionCriteria 
Details  Unexplained uterine bleeding
History of antibiotic treatment in the month preceding the biopsy,
Uterine malformation,
Cavity -deforming submucosal myoma
If patients are smokers or alcohol consumers
Do not wish to continue with this study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of SHUDE score in predicting chronic endometritis compared to the gold standard i.e CD 138 levels determined by immunohistiochemistry.  1 YEAR 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="125"
Sample Size from India="125" 
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)   25/08/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Brief Summary

In women with infertility development of scoring system for pathologies like endometriosis has aided in judging the severity and prognosticating pregnancy outcome in these women. In a community setting in India, where feasibility and cost involvement of doing CD 138 levels by immunohistiochemistry is not possible development off scoring system based on clinical and hysteroscopic findings will help in diagnosing chronic endometritis. Development of such a score would also help in counselling women regarding cumulative pregnancy rate. The scoring system established by this study including clinical and hysteroscopy criteria will have predictive value for the diagnosis of CE; it is hoped that the use of this system can reduce interobserver variability. The availability of this prediction model provides a counselling tool for physicians to IVF clients which ensures improved confidences level and reduced disappointments from failures in successful implantation and embryonic transfer including its associated financial costs and health risks.

 
 
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