| CTRI Number |
CTRI/2025/08/093938 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of pain perception and patient satisfaction during tubal patency assesment with HyCoSy and HSG in women with infertility. |
|
Scientific Title of Study
|
To compare the patient-reported outcomes during infertility
workup after introducing an evidence-based
three-dimensional/four-dimensional Hysterosalpingo-Contrast
Sonography over conventional Hysterosalpingography technique:
A Randomized Controlled Trial |
| 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 Soniya Dhiman |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No 710 Mother and Child Block, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8126399907 |
| Fax |
|
| Email |
soniyakvs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soniya Dhiman |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No 710 Mother and Child Block, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8126399907 |
| Fax |
|
| Email |
soniyakvs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanya Chaudhary |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No 121 hostel 14 AIIMS Campus New Delhi
New Delhi
DELHI
110029
India |
| Phone |
6306584027 |
| Fax |
|
| Email |
tanya.chaudhary3587@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute based PG Thesis Project |
| Address |
AIIMS, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tanya Chaudhary |
AIIMS, New Delhi |
Ansarinagar New Delhi mother and child block near gate no 6b
New Delhi
DELHI |
6306584027
tanya.chaudhary3587@gmail.com |
| Dr TanyaChaudhary |
All India Institute of Medical Sciences |
Mother and Child block department of obstetrics and gynaecology, Ansari Nagar near gate 6b
New Delhi
DELHI |
6306584027
tanya.chaudhary3587@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N971||Female infertility of tubal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hysterosalpingo-contrast sonography (HyCoSy) will be done for tubal patency testing in women with infertility |
Between day 6-10 of menstrual cycle HyCoSy will be done for tubal patency testing using transvaginal ultrasonography |
| Comparator Agent |
Hysterosalpingography (HSG) will be done for tubal patency in women with infertility |
HSG will be done between day 6-10 of menstrual cycle for tubal patency testing in women with infertility |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
1. Women presented with primary or secondary infertility
2. Age between 21 to 38 years
3. Ready to provide informed written consent |
|
| ExclusionCriteria |
| Details |
1. Women with active genital infection including cervicitis, vaginitis and PID
2. With history of contrast allergy
3. With history of iodine allergy
4. Abnormal vaginal bleeding |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain perception score in both groups using Visual Analogue Score of 0 to 10
2. Patient satisfaction in both group on a likert scale of 5 levels of satisfaction |
Day 3, Day 7 and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of visits required till the procedure for tubal patency in both groups
2. Duration of the procedure starting from insertion of speculum till completion of procedure in both groups
3. Number of patients with technically successful procedure in both group
4. Number of patients needed second procedure (diagnostic hysterolaparoscopy ) due to in conclusive result
5. Comparison of abnormal findings of HyCoSy and HSG with observations of laparoscopy and hysteroscopy
6. Comparison of side effects of HyCoSy procedure with HSG including vasovagal reaction and vaginal spotting
7. Number of patients conceived within 3 months after HyCoSy and HSG |
Day 3, Day 7 and 3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
08/09/2025 |
| 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="6"
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 how patients experience two common procedures used during infertility evaluations—3D/4D Hysterosalpingo-Contrast Sonography (HyCoSy) and conventional Hysterosalpingography (HSG). These tests are used to check if the fallopian tubes are open, which is important for natural conception. The primary objectives are: To compare pain levels experienced by patients during each procedure. To compare overall patient satisfaction with each method.
The study will take place in the outpatient department of Obstetrics and Gynaecology at AIIMS, New Delhi, after receiving approval from the Institute Ethics Committee. Eligible patients will be informed about the study and those who agree to participate will be randomly assigned to one of two groups: Procedure Details:In Group A (HyCoSy), patients undergo a 3D/4D ultrasound using a special contrast agent to view the uterus and fallopian tubes in real time. In Group B (HSG), an X-ray dye is used to visualize the same structures through radiographic images.
Pain during the procedure will be measured using a Visual Analogue Scale (VAS) from 0 to 10. Patient satisfaction will be recorded using a 5-point Likert scale. Other information collected includes: Demographics, medical and reproductive history, partner details, physical exams, and routine infertility workup. Some patients may require further diagnostic tests like laparoscopy if results are abnormal or unclear. Patients with normal test results will receive standard treatment and their pregnancy outcomes will be followed up for 3 months.
By comparing patient experiences and outcomes, this study will help determine whether the newer 3D/4D HyCoSy method offers a more comfortable and satisfying alternative to the traditional HSG test during infertility evaluation |