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An observational study to assess tubal patency in infertile women with Hycosy by using the Ultrasound contrast agent lignosal

Not Applicable
Conditions
Health Condition 1: null- Women referred for Hycosy(Hysterosalpingo contrast sonography)
Registration Number
CTRI/2018/05/013783
Lead Sponsor
Dr Ch V Narayana Rao
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Effectiveness of Lignocaine 2% w/v gel mixed with normal saline contrast mediumTimepoint: 1 Day
Secondary Outcome Measures
NameTimeMethod
Safety of Lignocaine 2% w/v gel mixed with normal saline contrast mediumTimepoint: 1 Day
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