H2Oil Randomized Controlled Trial using Lipiodol® Ultra-Fluide

Villepinte, May 18, 2017

Guerbet announced that a clinical study, published today in the New England Journal of Medicine and presented at the 13th World Congress on Endometriosis in Vancouver, Canada, shows interesting clinical data about hysterosalpingography examination with Lipiodol® Ultra-Fluide.

This large, multi-center, randomized controlled trial entitled “Oil-Based or Water-Based Contrast for hysterosalpingography in Infertile Women” and known as “The Water versus Oil (H2Oil)” was presented today by Professor Ben Mol of the Robinson Research Institute, University of Adelaide, Australia.


About the Trial Design

The H2Oil study was conducted by Professor Mol together with Dr. Kim Dreyer & Dr. Velja Mijatovic from the Department of Reproductive Medicine, VU University Medical Centre, Amsterdam, and their multi-center research team from 27 centers in the Netherlands.  The trial includes 1,119 women undergoing investigation for infertility with hysterosalpingography (HSG), the x-ray examination of the fallopian tubes with a contrast agent. The women were randomized to a standard HSG with a water-soluble contrast medium (WSCM) versus an oil-based contrast with Lipiodol® Ultra-Fluide [LIPIODOL® Ultra-Fluide 480 Injection 10 mL, GUERBET]. Then couples received expectant management or the women underwent intrauterine insemination.


Results  

In the WSCM HSG group, the ongoing pregnancy rate 6 months after was 29.1%, whilst in the Lipiodol® Ultra-Fluide HSG group it was 39.7%; this difference is statistically significant. Adverse event rates were low and similar in both groups. 

Pierre Desché, MD, Senior Vice-President – Development, Medical & Regulatory Affairs - Guerbet, said “this publication in the New England Journal of Medicine opens new horizons for hysterosalpingography (HSG) with Lipiodol® Ultra-Fluide and comes on top of a growing body of evidence in the field of HSG procedure as a main diagnostic line within fertility work-up.” 

[1] Dreyer K, et al.  Oil versus water-based contrast medium for hysterosalpingography in infertile women (H2Oil study); a randomised trial. N Eng J Med 2017 [ePub]


About hysterosalpingography (HSG)

HSG is a radiologic procedure to investigate the shape of the uterine cavity as well as the shape and patency of the fallopian tubes. It entails the injection of a radio-opaque agent into the cervical canal and usually fluoroscopy with image intensification. HSG is a main diagnostic line within the infertility work-up of infertile women.


About Lipiodol® Ultra-Fluide

Lipiodol® Ultra-Fluide is an Ethyl ester of iodinated fatty acids of poppy-seed oil injection; an oil-soluble contrast medium (OSCM) that has been used in diagnostic & interventional radiology for several decades. 

Lipiodol® Ultra-Fluide was initially developed for diagnostic radiology in indications including lymphography and hysterosalpingography, and has evolved for its use in interventional radiology procedures. Lipiodol® Ultra Fluide is indicated for hysterosalpingography in 13 countries across the world: Denmark, Ireland, The Netherlands, UK, Turkey, South-Africa, Japan, Taiwan, Thailand, Australia, New Zealand, USA & Canada.

The approved indications for Lipiodol® Ultra-Fluide may vary according to countries. Please refer to the local Summary of Product Characteristics.

This information is targeted to an international audience except the countries where the product or hysterosalpingography indication are not registered.