Villepinte (France) - March 23, 2020 - 06:00pm - Guerbet (GBT), a global leader in medical imaging, has announced that it 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 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 pregnancy and live birth rates is now endorsed by Hungary’s National Institute of Pharmacy and Nutrition and the Netherlands’ Medicines Evaluation Board.
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. 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.
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
In 2016, the Guerbet Group launched its Women’s Health franchise, focusing on fertility & breast cancer management in line with Guerbet’s ambition to develop a women healthcare portfolio of drugs & medical devices (http://guerbet-womenhealthcare.com/our-franchise/).
About the H2Oil trial
The H2Oil study, a multicenter, randomized, controlled trial, was conducted by Professor Ben Mol, Doctor Kim Dreyer and their multi-center research team from 27 hospitals in the Netherlands. A total of 1,119 women were randomly assigned to HSG with oil contrast (557 women) or water contrast (562 women). Rates of ongoing pregnancy and live births were higher among women who underwent HSG with Lipiodol® Ultra Fluid than among women who underwent this procedure with water contrast (39.7% versus 29.1%; 38.8% versus 28.1%). These differences were statistically significant. Adverse event rates were low and similar in both groups. The study was published on May 25, 2017 in The New England Journal of Medicine.1
About Lipiodol® Ultra Fluid
Lipiodol® Ultra Fluid (ethyl esters of iodized fatty acids of poppyseed oil) is the only oil-based contrast agent indicated for HSG. Lipiodol® Ultra Fluid is also approved for use in interventional radiology for conventional trans-arterial chemo-embolization (cTACE), for vascular embolizations and for lymphography. Lipiodol® Ultra Fluid is available in 47 countries. Indications may vary from country to country, please refer to the local Summary of Product Characteristics. Lipiodol® Ultra Fluid is indicated for HSG in 12 countries (USA, Canada, Argentina, UK, Denmark, Turkey, South-Africa, Japan, Taiwan, Thailand, Australia and New Zealand). Lipiodol® Ultra Fluid is indicated for HSG in women undergoing infertility workup in Ireland, Hungary and the Netherlands.
Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients. A pioneer since more than 90 years in the field of contrast media with over 2,800 people globally, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019. For more information about Guerbet, please visit www.guerbet.com.
 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.
 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.
 A policy audit on fertility. Analysis of 9 EU countries. March 2017. Fertility Europe.