Guerbet has received indication approval in Hungary and the Netherlands where Lipiodol® Ultra Fluid is now indicated for hysterosalpingography (HSG) in women undergoing infertility workup. Hungary and the Netherlands are the second and third European countries to grant approval for this indication after Ireland.
HSG is an x-ray procedure during which Lipiodol® Ultra Fluid is slowly infused through a catheter into the uterus to visualizethe 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 pregnancy and live birth rates is now endorsed by Hungary’s National Institute of Pharmacy and Nutrition and the Netherlands’ Medicines Evaluation Board. [1]
Lipiodol® Ultra Fluid is now approved for HSG in women undergoing infertility workup in Ireland, Hungary, and in the Netherlands. In addition to these three countries, Lipiodol® Ultra Fluid is approved for HSG in 12 countries, where Guerbet aims to extend the indication to women undergoing infertility workup. Guerbet also plans to receive authorization for this indication throughout Europe, APAC and Latin America.
“In order to clarify the uncertainty around the use of oil- or water-based contrast for HSG, the H2Oil study, a large randomized trial, in which 1,119 infertile women participated, was conducted in the Netherlands. This landmark study, published in the New England Journal of Medicine, showed significantly 10% more ongoing pregnancies as well as live births in the first six months following HSG with oil-based contrast, as compared to HSG with water-based contrast.1 Publication of the study generated a worldwide renewed interest in tubal flushing and the use of oil-based contrast for HSG. And an economic analysis based on the data of the H2Oil study showed a favorable cost-effectiveness ratio for oil-based contrast compared to water-based contrast for an additional ongoing pregnancy. [2] Thus, there is a strong argument to incorporate tubal flushing with oil-based contrast during HSG in clinical practice”, said Professor Velja Mijatovic, Department of Reproductive Medicine, Amsterdam University Medical Center, on behalf of the H2Oil study group.
Infertility is defined as the inability to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse. It is estimated that one in six couples faces infertility issues. [3]
This indication is supported by the positive results of the H2Oil trial, a multicenter, randomized, open-label study, published in The New England Journal of Medicine. In the trial, an HSG performed with Lipiodol® Ultra Fluid significantly increased pregnancy and live birth rates as compared to an HSG performed with a water-based contrast medium. Women were randomly assigned to either HSG with Lipiodol® Ultra Fluid (n=554) or HSG with a water-soluble contrast agent (n=554). After a follow-up of 6 months, the pregnancy rate was 39.7% and 29.1% respectively (rate ratio (RR) 1.37 [1.16; 1.61], p<0.001) and the live birth rate was 38.8% and 28.1% respectively (RR 1.38 [1.17; 1.64], p<0.001).1
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] van Rijswijk J et al. Oil-based or water-based contrast for hysterosalpingography in infertile women: a cost-effectiveness analysis of a randomized controlled trial. Fertil Steril. 2018 Sep;110(4):754-760.
[3] A policy audit on fertility. Analysis of 9 EU countries. March 2017. Fertility Europe.