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The data collection team stopped recruiting cases.
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo university Kasr Alainy OBGYN hospital | Cairo | AlQuahira | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2022 |
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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 |
| Dec 2, 2024 |
| Prot_SAP_000.pdf |