Drug updated on 10/29/2024
Dosage Form | Foam (intrauterine; single dose kit: one syringe with 5 mL clear Gel [polymer type A–hydoxyethyl cellulose, glycerin and purified water], one syringe with 5 mL Sterile Purified Water and one Combifix® Adaptor [coupling device] |
Drug Class | Ultrasound contrast agents |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- For diagnosing tubal occlusion in women with infertility, 2D-HyCoSy had a sensitivity of 86% (95% CI (confidence interval) 80%-91%) and a specificity of 94% (95% CI 90%-96%), while 3D/4D-HyCoSy showed higher sensitivity at 95% (95% CI 89%-98%) but slightly lower specificity at 89% (95% CI 82%-94%).
- There were no significant differences in diagnostic performance between the two methods, and no other drugs were compared in terms of effectiveness.
- The overall frequency of severe pain perception during HyCoSy was 6% (95% CI 4-9), with no statistically significant differences based on the contrast used (Saline solution with air, EchoVist, SonoVue, ExEm-Foam).
- No significant safety concerns or adverse effects specific to certain populations or subgroups were identified in the reviewed studies.
- The studies focused on women undergoing HyCoSy for infertility assessment, with no significant differences in diagnostic accuracy or severe pain perception based on the type of contrast used.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
ExEm Foam (air polymer-type A) Prescribing Information. | 2022 | ExEm Foam Inc., New York, NY |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Two-dimensional hysterosalpingo-contrast-sonography compared to three/four-dimensional hysterosalpingo-contrast-sonography for the assessment of tubal occlusion in women with infertility/subfertility: a systematic review with meta-analysis. | 2022 | Human fertility (Cambridge, England) |
Severe pain during hysterosalpingo-contrast sonography (HyCoSy): a systematic review and meta-analysis | 2021 | Archives of Gynecology and Obstetrics |