Drug updated on 4/18/2024
| 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.
Summary
- Air polymer-type A (ExEm Foam) is indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility.
- The information provided comes from a single systematic review/meta-analysis that focuses on the use of ExEm Foam in diagnostic procedures related to female infertility.
- This study compares two ultrasound-based techniques, 2D and 3D/4D-HyCoSy, which are used to evaluate tubal patency. Although ExEm Foam is not directly mentioned, these methods could utilize this substance as a contrast agent.
- Between January 1990 and April 2019, thirty studies were analyzed, finding both imaging modalities offer high diagnostic accuracy: sensitivity and specificity rates were approximately 86% and 94% respectively for the former method, and around 95% and 89% respectively for the latter one. There was no significant difference between them, indicating their effectiveness in assessing fallopian tube patency.
- The findings may be broadly applicable across women experiencing fertility issues due to the extensive range of included studies over an extended timeframe.
- No direct comparisons regarding the performance of ExEm Foam versus other contrast agents were made; however, the evaluation of the HyCoSy techniques' accuracy, where substances like ExEm Foam would serve as a contrast medium, indirectly highlights the importance of enhancing diagnostic accuracy in assessing tubal patency.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| ExEm Foam Prescribing Information. | 2022 | ExEm Foam Inc., New York, NY |