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CTRI Number  CTRI/2025/07/091263 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 20/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of 3D ultrasound and hysteroscopy to examine the uterus in women with repeated pregnancy loss and infertility 
Scientific Title of Study   Comparative study of 3D ultrasonography with hysteroscopy for the evaluation of uterine cavity in women with recurrent pregnancy loss and infertility 
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 Nishtha Goel 
Designation  Post Graduate Resident 
Affiliation  Kasturba Hospital Delhi 
Address  Department of Obstetrics and Gynecology, Kasturba Hospital, Daryaganj, near Jama Masjid, Delhi

Central
DELHI
110002
India 
Phone  9810143274  
Fax    
Email  nishtha98.goel@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinita Sarbhai 
Designation  Senior Specialist, SAG 
Affiliation  Kasturba Hospital Delhi 
Address  Department of Obstetrics & Gynecology, Kasturba Hospital, Delhi

Central
DELHI
110002
India 
Phone  9810359546  
Fax    
Email  vinitasarbhai@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vinita Sarbhai 
Designation  Senior Specialist, SAG 
Affiliation  Kasturba Hospital Delhi 
Address  Department of Obstetrics & Gynecology, Kasturba Hospital, Delhi

Central
DELHI
110002
India 
Phone  9810359546  
Fax    
Email  vinitasarbhai@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Hospital, Daryaganj, near Jama Masjid, Delhi, India 110002 
 
Primary Sponsor  
Name  Dr Nishtha Goel 
Address  Department of Obstetrics and Gynecology, Kasturba Hospital, Daryaganj, near Jama Masjid, Delhi, India 110002 
Type of Sponsor  Government medical college 
 
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 Nishtha Goel  Kasturba Hospital  Department of Obstetrics and Gynecology, Kasturba Hospital, Daryaganj, Near Jama Masjid, Delhi, India 110002
Central
DELHI 		 9810143274

nishtha98.goel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N96||Recurrent pregnancy loss, (2) ICD-10 Condition: N97||Female infertility,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women of age group more than 18 years, who have had 2 or more spontaneous, consecutive pregnancy losses in the first 20 weeks of gestation or are unable to achieve pregnancy despite 1 year of regular, unprotected sexual intercourse with husband. 
 
ExclusionCriteria 
Details  Pregnant women

Active pelvic inflammatory disease

Undiagnosed excessive uterine bleeding

Bleeding disorders or any coagulation defect,

Cancer of genital tract

Vaginismus

Any medical condition making patient unfit for anesthesia

Contraindication to hysteroscopy or transvaginal ultrasound 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Diagnostic accuracy of 3D ultrasonography in comparison to hysteroscopy (sensitivity, specificity, PPV, NPV) for detection of uterine abnormalities.  At baseline when 3D ultrasound is done, and then at 2 weeks when hysteroscopy is done postmenstrually 
 
Secondary Outcome  
Outcome  TimePoints 
Detection rate of uterine abnormalities & intracavitary lesions by each method,
Types of congenital & acquired uterine abnormalities identified by each modality,
Patient tolerability & adverse event rate by each modality 		 at baseline when 3D ultrasound is done, & then at 2 weeks when hysteroscopy is done post menstrually 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
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)   01/09/2025 
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   This thesis protocol aims to compare the diagnostic efficacy of 3D transvaginal ultrasonography with diagnostic hysteroscopy in the evaluation of uterine abnormalities contributing to recurrent pregnancy loss and infertility. Conducted as a prospective comparative study at Kasturba Hospital, Delhi, it involves 39 women undergoing 3D TVS followed by hysteroscopy. 3D transvaginal ultrasonography, a less invasive technique is hypothesised to have diagnostic accuracy comparable to hysteroscopy in detecting uterine abnormalities in women with recurrent pregnancy loss and infertility. With ethical approval secured, this research seeks to help clinical decision making and optimise the diagnostic approach for women experiencing reproductive failure. 
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