CTRI

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CTRI Number

CTRI/2025/12/099648 [Registered on: 22/12/2025] Trial Registered Prospectively

Last Modified On:

19/12/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparison of two methods of hysteroscopy in women undergoing diagnostic hysteroscopy

Scientific Title of Study

Comparison of Standard Technique and Vaginoscopic Technique of Hysteroscopy in terms of intraoperative outcome in women undergoing Diagnostic Hysteroscopy under Anasthesia

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Harshita Kori
Designation	PostGraduate
Affiliation	Lady Hardinge Medical College SSKH hospital
Address	RMO A room number 8 bangla sahib road New Delhi Lady Hardinge Medical College SSKH Delhi Central DELHI 110001 India
Phone	9340602856
Fax
Email	joekori455@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Aishwarya Kpaur
Designation	Professor
Affiliation	Lady Hardinge Medical College SSKH
Address	Lady Hardinge Medical College SSKH Delhi Central DELHI 11 India
Phone	8851605061
Fax
Email	aish9kapur@gmail.com

Details of Contact Person
Public Query

Name	Dr Aishwarya Kpaur
Designation	Professor
Affiliation	Lady Hardinge Medical College SSKH hospital
Address	Lady Hardinge Medical College SSKH Delhi Central DELHI 110001 India
Phone	08851605061
Fax
Email	aish9kapur@gmail.com

Source of Monetary or Material Support

Lady Hardinge Medical College Smt Sucheta Kriplani Hospital

Primary Sponsor

Name	Lady Hardinge Medical College and SSKH Hospital
Address	Lady Hardinge Medical College and SSKH hospital Shaheed Bhagat Singh Marg Connaught Place New Delhi 110001
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 Harshita Kori	Lady Hardinge Medical College Smt Sucheta Kriplani Hospital	Department of Obstetrics and Gynaecology Lady Hardinge Medical College Shaheed Bhagat Singh Marg Connaught Place New Delhi 110001 Central DELHI	09340602856 joekori455@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee Lady Hardinge Medical College and Associated Hospitals	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
Comparator Agent	Standard Hysteroscopy	Conventional hysteroscopy done using speculum and vulselum hysteroscope inserted
Intervention	Vaginoscopic Technique	Hysteroscopy performed using the vaginoscopiic (no touch) technique without the use of speculum or cervical instrumentation under anasthesia hysteroscope inserted

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Female
Details	Women undergoing diagnostic hysteroscopy under general / regional anesthesia for indications such as abnormal uterine bleeding, infertility recurrent pregnancy loss or suspected intrauterine pathology (e.g. polyps, submucosal fibroids).

ExclusionCriteria

Details

Women with previous history of surgeries involving cervix (e.g. H/o Manchester operation cervical conisation etc.)
Pregnant women or those with suspected pregnancy.
Presence of active pelvic infection or genital tract infection.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Time taken for hysteroscope entry into the uterine cavity (in minutes and second)	Time taken for hysteroscope entry into the uterine cavity (in minutes and second)

Secondary Outcome

Outcome	TimePoints
Proportion of women requiring Conversion of technique from group 2 to group 1. Proportion of women having intraoperative complications (cervical laceration, uterine perforation, bleeding) in both groups. Postoperative pain after 6 hours of procedure (using VAS).	Intraoperative 6 hours post procedure

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
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)

31/12/2025

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 Yet Recruiting

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 study aims to compare the standard technique of diagnostic hysteroscopy with the vaginoscopic technique in women undergoing the procedure under anesthesia. The objective is to evaluate intraoperative outcomes including ease of procedure, need for conversion from vaginoscopic to standard technique, and occurrence of complications such as cervical laceration, uterine perforation, and bleeding. The study will also assess postoperative pain at six hours using the Visual Analogue Scale. Participants will be randomly allocated into two groups to compare the effectiveness and safety of the two techniques.