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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Tubal Factor Infertility

Intervention / Treatment
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* Diagnostic Test: Hysterosalpingo-lidocaine-foam-sonography combined with power doppler (HyLiFoSy-PD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age group (18-40) Informed signed Written consent. Scheduled for LDT as a part of their infertility management Have undergone HSG in the previous 5 years with the availability of good-quality HSG images. 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: LDT scheduled for a therapeutic purpose due to a known tubal or ovarian pathology Lack of good-quality HSG images. Withdrawal of consent. Using contraception Women outside reproductive age Known allergy to lidocaine Active pelvic inflammatory disease Undiagnosed genital tract bleeding. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Hysterosalpingo-lidocaine-foam-sonography combined with power doppler (HyLiFoSy-PD)|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |