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

Recruiting

Conditions: Women referred for Hycosy(Hysterosalpingo contrast sonography)

Registration Number: CTRI/2018/05/013783

Lead Sponsor: Dr Ch V Narayana Rao

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 60

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

Name	Time	Method
Effectiveness of Lignocaine 2% w/v gel mixed with normal saline contrast medium	1 Day

Secondary Outcome Measures

Name	Time	Method
Safety of Lignocaine 2% w/v gel mixed with normal saline contrast medium	1 Day

Trial Locations

Locations (1): Shilpa Scan Center
🇮🇳
Godavari, ANDHRA PRADESH, India
Shilpa Scan Center
🇮🇳Godavari, ANDHRA PRADESH, India
Dr Ch V Narayana Rao
Principal investigator
9849611266
chnr42@yahoo.com