| CTRI Number |
CTRI/2018/05/013783 [Registered on: 09/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
10/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study to assess tubal patency in infertile women with Hycosy by using the Ultrasound contrast agent lignosal |
|
Scientific Title of Study
|
Hycosy(Hysterosalpingocontrastsonography) by using the Ultrasound contrast agent lignosal (mixture of 2% lignocaine jelly and saline) for the evaluation of tubal patency in infertile women an observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ch V Narayana Rao |
| Designation |
Sonologist |
| Affiliation |
Shilpa Scan Center |
| Address |
Sonology Division,
Shilpa Scan Center,
Opp. Telephone Exchange
Palakol, Andhra Pradesh
West Godavari
ANDHRA PRADESH
534260
India |
| Phone |
9849611266 |
| Fax |
|
| Email |
chnr42@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ch V Narayana Rao |
| Designation |
Sonologist |
| Affiliation |
Shilpa Scan Center |
| Address |
Sonology Division,
Shilpa Scan Center,
Opp. Telephone Exchange
Palakol, Andhra Pradesh
West Godavari
ANDHRA PRADESH
534260
India |
| Phone |
9849611266 |
| Fax |
|
| Email |
chnr42@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ch V Narayana Rao |
| Designation |
Sonologist |
| Affiliation |
Shilpa Scan Center |
| Address |
Sonology Division,
Shilpa Scan Center,
Opp. Telephone Exchange
Palakol, Andhra Pradesh
West Godavari
ANDHRA PRADESH
534260
India |
| Phone |
9849611266 |
| Fax |
|
| Email |
chnr42@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr Ch V Narayana Rao
Shilpa Scan Center
Opp Telephone Exchange
Palakol, Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Ch V Narayana Rao |
| Address |
Shilpa Scan Center
Opp Telephone Exchange
Palakol, Andhra Pradesh |
| Type of Sponsor |
Other [Self] |
|
|
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 Ch V Narayana Rao |
Shilpa Scan Center |
Sonology Division,
Shilpa Scan Center,
Opp. Telephone Exchange
Palakol, Andhra Pradesh
West Godavari
ANDHRA PRADESH |
9849611266
chnr42@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S2J INDEPENDENT ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Women referred for Hycosy(Hysterosalpingo contrast sonography), |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Lignocaine 2% w/v gel mixed with normal saline contrast medium |
Lignocaine 2% w/v gel mixed with normal saline contrast medium |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1)Participants willing to sign an Informed Consent Form indicating that they understand the purpose of and the procedures required for the study and are willing to participate in it.
2)Female patients of child bearing age, 18 - 50 years of age who are referred to the Study site to undergo Tubal Patency Test using HyCoSy (Hysterosalpingo Contrast Sonography) procedure.
|
|
| ExclusionCriteria |
| Details |
1)Patients with known allergy to the ingredients of the contrast medium.
2)Pregnant or breast-feeding women
3)Presence of any other clinically significant disease or laboratory findings that in the Investigator opinion may affect efficacy or safety assessments.
4)History of alcohol or drug abuse, or suspicion thereof in the Investigator judgment.
5)History of or active hepatitis B or C within the past 3 months or history of HIV infection.
6)History of seizure disorder or epilepsy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of Lignocaine 2% w/v gel mixed with normal saline contrast medium |
1 Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of Lignocaine 2% w/v gel mixed with normal saline contrast medium |
1 Day |
|
|
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)
|
20/04/2018 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Tubal patency testing plays a vital role in female infertility workup because tubal obstruction is estimated to play a very significant role in 12-33% of infertile couples. Currently several tests are available to assess the tubal patency. X-ray HysteroSalpingoGraphy (HSG) is performed mainly using oil or water based contrast. It has several disadvantages such as severe pain, exposure to radiation and potential allergic reactions to contrast agent. Laproscopic chromotubation evaluation with methylene blue has some risk associated with surgery and anesthesia and is more expensive. Another cost effective modality is to inject water and air mixture into uterine cavity. While doing transvaginal color Doppler, we can see the fluid and air bubbles around the ovaries (saline infusion sonography). The disadvantages in this procedure are tubes cannot be visualized and the patient experiences severe pain, vomiting sensation and dizziness. HysterosalpingoContrastSonography(HyCoSy) is another ultrasound guided procedure using Echovist (Shering AG,Berlin,Germany) or SonoVue (Bracco International BV Amsterdam,The Netherlands). These products consist of aqueous galactose solution. This procedure is very accurate but very expensive and restricted to patients in first world countries.
For this observational study we intend to observe the effectiveness and safety of Lignocaine 2 % w/v gel mixed with Normal Saline contrast medium for determination of Tubal Patency using HyCoSy (Hysterosalpingo Contrast Sonography) procedure.
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