Drug updated on 9/5/2024
| 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.
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Summary
- Exem Foam (air polymer-type a) is indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility.
- This summary is based on the review of one systematic review(s)/meta-analysis(es). 3. [1]
- D-HyCoSy: Demonstrated a sensitivity of 86% (95% CI: 80%-91%) and a specificity of 94% (95% CI: 90%-96%) in assessing tubal occlusion in women with infertility. 4.
- D/4D-HyCoSy: Showed a sensitivity of 95% (95% CI: 89%-98%) and a specificity of 89% (95% CI: 82%-94%) for the same condition.
- Comparison: 3D/4D-HyCoSy had higher sensitivity (95% vs. 86%), while 2D-HyCoSy had higher specificity (94% vs. 89%). No statistically significant differences were found between the methods (p = 0.13).
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| ExEm Foam (air polymer-type A) Prescribing Information. | 2022 | ExEm Foam Inc., New York, NY |