Comparison of the Diagnostic Accuracy of Hysterosalpingo-lidocaine-foam Sonography Versus Hysterosalpingography in Tubal Patency Assessment to the Gold Standard of Laparoscopy and Dye Testing

Terminated

• Conditions: Tubal Factor Infertility

• Registration Number: NCT05419921
• Lead Sponsor: Cairo University

Brief Summary

This is a cross-sectional study that compares the diagnostic accuracy of Hysterosalpingo-lidocaine-foam sonography combined with power doppler (HyLiFoSy-PD) in the assessment of tubal patency, with the diagnostic accuracy of hysterosalpingogram (HSG), and to the gold standard of laparoscopy and dye testing.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-11
• Study First Posted: 2022-06-15
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 122

Inclusion Criteria

1. Age group (18-40)
2. Informed signed Written consent.
3. Scheduled for LDT as a part of their infertility management
4. Have undergone HSG in the previous 5 years with the availability of good-quality HSG images.
5. No incident factors that might have affected the tubal status after she underwent HSG within the previous 5 years, such as ; abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion.

Exclusion Criteria

1. LDT scheduled for a therapeutic purpose due to a known tubal or ovarian pathology
2. Lack of good-quality HSG images.
3. Withdrawal of consent.
4. Using contraception
5. Women outside reproductive age
6. Known allergy to lidocaine
7. Active pelvic inflammatory disease
8. Undiagnosed genital tract bleeding.
9. Evident tubal pathology (such as hydrosalpinx) or pregnancy diagnosed by transvaginal ultrasound (TV-US) prior to performing HyLiFoSy-PD 10- Incident factors that might have affected the tubal status after she underwent HSG within the previous 5 years, such as ; abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of HyLiFoSy and HSG with reference to LDT, in terms of sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy.	July 2022- June 2024

Secondary Outcome Measures

Name	Time	Method
Incidence and rate of potential complications for example: vasovagal and allergic reactions, venous intravasation	July 2022- June 2024
Evaluate the procedure associated pain	July 2022- June 2024	Pain will be assessed during the procedure (after insertion of Foley's catheter, during injection of lidocaine-made gel foam) using the verbal rating scale (VRS). Interpretation will be like: no pain, mild pain, moderate pain, severe pain.
Evaluate the procedure duration	July 2022- June 2024	Duration is calculated in minutes, from the introduction of Cusco speculum to the exit of Foley's catheter
Percentage of failed or inconclusive attempts and possible reasons for that	July 2022- June 2024

Trial Locations

Locations (1)

Cairo university Kasr Alainy OBGYN hospital; 🇪🇬 Cairo, AlQuahira, Egypt