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

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.

Study Overview

• Status: Terminated
• Conditions: Tubal Factor Infertility
• Intervention / Treatment: Diagnostic test: Hysterosalpingo-lidocaine-foam-sonography combined with power doppler (HyLiFoSy-PD)

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• Egypt
  • AlQuahira
    • Cairo, AlQuahira, Egypt
      • Cairo university Kasr Alainy OBGYN hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Women in the reproductive age group between 18- and 40-years old presenting with primary or secondary infertility who underwent HSG in the previous 5 years as a part of their infertility work-up with availability of good-quality HSG images, & did not get pregnant in this period, and gave no history of incidences that might affect their tubes, such as : abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion.

Women fitting these inclusion criteria and scheduled for LDT as part of their infertility work up will be considered. HyLiFoSy-PD will be carried out few days before the already scheduled LDT.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Evaluate the procedure associated pain	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.	July 2022- June 2024
Evaluate the procedure duration	Duration is calculated in minutes, from the introduction of Cusco speculum to the exit of Foley's catheter	July 2022- June 2024
Percentage of failed or inconclusive attempts and possible reasons for that		July 2022- June 2024
Incidence and rate of potential complications for example: vasovagal and allergic reactions, venous intravasation		July 2022- June 2024

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Shaimaa Mostafa; Yasmin Zakaria; Ibrahim Fawzy; Mona Aboulghar; Mona Fouad

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 11, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: IT28052022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No