Villepinte (France) – February 12, 2020 - 06:00pm - Guerbet (GBT) has announced that it has been granted approval for an indication extension in Ireland, where Lipiodol® Ultra Fluid is now indicated for hysterosalpingography (HSG) in women undergoing infertility workup. 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).,,
Lipiodol® Ultra Fluid is currently approved for HSG in 14 countries, where Guerbet aims to extend the indication to women undergoing infertility workup, as already obtained in Ireland.
In addition to these 14 countries, Guerbet plans to receive authorization for this indication in 29 other countries in Europe, APAC and Latin America.
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 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.
- In a single-center, randomized, controlled trial, infertile women (with unexplained infertility or endometriosis) were randomly assigned to HSG with Lipiodol® Ultra Fluid (n=73) or no HSG (n=85). The pregnancy rate at 6 months’ follow-up was 38.4% and 16.5% respectively (p=0.002) and the live birth rate was 31.5% and 12.9% respectively (p=0.005).2,3
- In a multicenter, randomized, open-label study, the H2Oil trial, published in The New England Journal of Medicine, 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
- A meta-analysis of randomized controlled trials showed an overall odds ratio (OR) for pregnancy within 6 months after the procedure significantly in favor of HSG with Lipiodol® Ultra Fluid: OR of 3.47 [1.98; 6.08] when compared to no HSG (p<0.001, 3 studies, 382 women) and OR of 1.59 [1.28; 1.98] when compared to HSG with a water-soluble iodinated contrast agent (p<0.001, 4 studies, 1,510 women).
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 13 countries (USA, Canada, Argentina, UK, The Netherlands, 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.
Guerbet is a leader in medical imaging worldwide, offering a comprehensive range of pharmaceutical products, medical devices, software and services 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, Guerbet is a substantial investor in research and innovation with more than 8% of revenue dedicated to R&D and more than 200 employees distributed amongst its four centers in France, Israel and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €790 million in revenue in 2018. 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.
 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.
 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.
 A policy audit on fertility. Analysis of 9 EU countries. March 2017. Fertility Europe.