Healthcare 21 is delighted to announce that our partner Guerbet has been granted an indication extension in Ireland, where Lipiodol® Ultra Fluid is now indicated for hysterosalpingography (HSG) in women undergoing infertility workup.

This indication extension is supported by the positive results of two clinical trials and one meta-analysis, where HSG with Lipiodol® Ultra Fluid increased pregnancy and live birth rates as compared to no HSG or to HSG performed with a water-based contrast medium, as now described in Section 5.1 of the Irish PI.

Ireland is the first country to approve this indication. HSG is an x-ray procedure during which Lipiodol® Ultra Fluid is slowly infused through a catheter into the uterus to visualize the Fallopian tubes and uterine cavity. Lipiodol® Ultra Fluid is the only oil-soluble contrast medium indicated for HSG. New clinical evidence showing that HSG with Lipiodol® Ultra Fluid enhances fertility has now been endorsed by Ireland’s Health Products Regulatory Authority (HPRA).^[1],[2],[3]

Lipiodol Ultra Fluid

This is an exciting new development in the infertility field, and we at Healthcare 21 are pleased to provide this product and support to our customers. For more information, please contact our Field Sales Manager, Jackie Knox (Email: jackie.knox@hc21.ie, Mobile: 00353 87 697 6800).

Further information can be found on the Guerbet website.

References:

[1] Dreyer K et al. Oil-based or water-based contrast for hysterosalpingography in infertile women. N Engl J Med. 2017 May 25;376(21):2043-52.

[2] Johnson NP et al. The FLUSH trial–flushing with Lipiodol for unexplained (and endometriosis-related) subfertility by hysterosalpingography: a randomized trial. Hum Reprod. 2004 Sep;19(9):2043-51.

[3] Johnson NP et al. Lipiodol fertility enhancement: two-year follow-up of a randomized trial suggests a transient benefit in endometriosis, but a sustained benefit in unexplained infertility. Hum Reprod. 2007 Nov;22(11):2857-62.