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

N/ATerminatedNCT05419921

Cairo University122 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

122

Conditions

Tubal Factor Infertility

Interventions

Hysterosalpingo-lidocaine-foam-sonography combined with power doppler (HyLiFoSy-PD)DIAGNOSTIC_TEST

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cairo university Kasr Alainy OBGYN hospital

Cairo, AlQuahira, Egypt

Outcomes

Primary Outcomes

Diagnostic accuracy of HyLiFoSy and HSG with reference to LDT, in terms of sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy.