| CTRI Number |
CTRI/2025/08/092154 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A comparative study of 3D Transvaginal Ultrasonography(3D USG)and Diagnostic Hysteroscopy (a small endoscopy of uterus) in detection of uterine abnormalities in women who are undergoing advanced fertility treatment |
|
Scientific Title of Study
|
Comparison of 3D Transvaginal Ultrasonography and Diagnostic Hysteroscopy in detection of uterine abnormalities in women undergoing advanced fertility 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 |
Nova Shinde |
| Designation |
Fellow |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Kadu Hospital, near SBI, Akhada Road, Pandharkawada, Yavatmal
Wardha
MAHARASHTRA
445302
India |
| Phone |
9765459555 |
| Fax |
|
| Email |
nova.shinde@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nova Shinde |
| Designation |
Fellow |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Kadu Hospital, near SBI, Akhada Road, Pandharkawada, Yavatmal
Wardha
MAHARASHTRA
445302
India |
| Phone |
9765459555 |
| Fax |
|
| Email |
nova.shinde@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nova Shinde |
| Designation |
Fellow |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Kadu Hospital, near SBI, Akhada Road, Pandharkawada, Yavatmal
Wardha
MAHARASHTRA
445302
India |
| Phone |
9765459555 |
| Fax |
|
| Email |
nova.shinde@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research,
Sawangi Meghe, Wardha, Maharashtra, India- 442001 |
|
|
Primary Sponsor
|
| Name |
Jawarlal Nehru Medical College |
| Address |
Department of OBGY, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha |
| Type of Sponsor |
Private medical college |
|
|
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 Deepti Shrivastava |
Jawaharlal Nehru Medical College, Sawangi |
Wardha test tube baby centre, Jawaharlal Nehru Medical College, Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha- 442107
Wardha
MAHARASHTRA |
9860817801
deeptishrivastava_69@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
diagnostic hysteroscopy |
diagnostic hysterosocpy will be done and findings will be compared with those of 3D transvaginal ultrasonography |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Women with primary of secondary infertility undergoing advanced fertility treatments like IUI and IVF , consenting for 3D transvaginal ultrasonography and Diagnostic Hysteroscopy |
|
| ExclusionCriteria |
| Details |
-Patients with already diagnosed uterine abnormalities.
-Cervical stenosis.
-Inability to perform Hysteroscopy due to any contraindication.
-Current STI/ PID |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the findings of Diagnostic Hysteroscopy and 3D Transvaginal Ultrasonography for detection of uterine abnormalities in women with subfertility. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the diagnostic accuracy of 3D Transvaginal Ultrasonography with Diagnostic Hysteroscopy in detecting uterine abnormalities in women with subfertility taking advanced fertility treatment. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
18/08/2025 |
| 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="0"
Months="2"
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
|
The study will be conducted in Wardha Test Tube Baby centrein AVBRH, Sawangi Meghe, Wardha. Baseline blood investigations and hormonal profile of the subjects will be done. All women satisfying the inclusion criteria will be subjected to 2D Transvaginal Ultrasound followed by 3D Transvaginal Ultrasonography in follicular phase, after informed consent and thorough history and physical examination. Subjects will then be posted for Hysteroscopy after obtaining fitness for surgery. Intra-operative findings will be noted. The 3D Transvaginal Ultrasonography and Hysteroscopy will be performed independently by two separate individuals and the respective findings will not be shared between the observers. The data will be analysed and diagnostic accuracy of both the procedures will be calculated and compared. |