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CTRI Number  CTRI/2025/05/086218 [Registered on: 02/05/2025] Trial Registered Prospectively
Last Modified On: 30/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two methods of uterus evaluation by hysteroscopy  
Scientific Title of Study   COMPARATIVE EVALUATION OF VAGINOHYSTEROSCOPY VERSUS TRADITIONAL HYSTEROSCOPY  
Trial Acronym  CVHTH 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bani Gupta  
Designation  PG resident  
Affiliation  Kasturba Hospital Delhi 
Address  WZ 3943 B upper ground floor Gali no 1 shri nagar shakur basti 110034 NEW DELHI, DELHI 110034 India
Room no 213, department of obstetrics and gynaecology, Kasturba hospital, Daryaganj, Delhi 110002
Central
DELHI
110034
India 
Phone  9873205096  
Fax    
Email  guptabani.bg@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
110006
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
110006
India 
Phone  9810359546  
Fax    
Email  vinitasarbhai@gmail.com  
 
Source of Monetary or Material Support  
Municipal Corporation of Delhi, Kasturba Hospital, Daryaganj, DELHI, INDIA-110002 
 
Primary Sponsor  
Name  Dr Bani Gupta  
Address  Municipal Corporation of Delhi, Kasturba Hospital, Daryaganj, 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 Bani Gupta  Kasturba Hospital Delhi   J6XQ+H5G, Near Jama Masjid Metro Station, Gate No.1, Kasturba Hospital Marg, Old Delhi, New Delhi, Delhi 110006
Central
DELHI 		 09873205096

guptabani.bg@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Isntitutional 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: N939||Abnormal uterine and vaginal bleeding, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Traditional Hysteroscopy  Traditional hysteroscopy is performed after retracting the posterior vaginal wall and holding the anterior lip of the cervix with a tenaculum. This is the conventional method used in routine gynecological practice 
Intervention  Vaginohysteroscopy  Vaginohysteroscopy is a minimally invasive alternative to traditional hysteroscopy that avoids the use of a speculum and tenaculum. It reduces pain and procedure time while improving patient comfort, compliance, and satisfaction. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Abnormal uterine bleeding
Post-menopausal bleeding
polyp
uterine fibroid
 
 
ExclusionCriteria 
Details  Pregnant women

Cervical cancer

Active infection of genital tract

Blood dyscrasia and coagulopathy

Cannot tolerate a speculum insertion due to
vaginismus.

Virginal status

Having medical conditions making them unfit for anesthesia if need be.

Active heavy bleeding 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome:
Success rate of Vaginohysteroscopy and traditional hysteroscopy which includes ability to enter the uterine cavity and satisfactory evaluation of the uterine cavity.
 		 Immediate at baseline  
 
Secondary Outcome  
Outcome  TimePoints 
1. Time taken from introduction to entry into cavity till both the ostia are visible & total procedural time for diagnostic procedure.
2.Pain assessment using Visual analogue scale which is a 10-point scale with 0= no pain & 10= worst pain.
3. Patient Satisfaction by Likert Scale 		 1. Immediate at Baseline assessment of time taken
2. Pain & Satisfaction will be assessed after 1 day  
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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   Phase 3 
Date of First Enrollment (India)   02/06/2025 
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="0"
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 vaginohysteroscopy with traditional hysteroscopy in terms of efficacy, patient comfort, complications, and procedural ease. Conducted as a randomized clinical trial at Kasturba Hospital, Delhi, it involves 44 women undergoing office hysteroscopy. Vaginohysteroscopy, a less invasive technique that avoids speculum and tenaculum use, is hypothesized to cause less pain, improve patient satisfaction, and reduce complications. The study evaluates success rates, procedure time, pain (VAS), and satisfaction (Likert scale). With ethical approval secured, this research seeks to support a more patient-friendly approach to diagnostic hysteroscopy in gynecological practice. 
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