Landmark study, published today in the New England Journal of Medicine, and presented at the 13th World Congress on Endometriosis in Vancouver, Canada, confirms significant fertility benefit from Lipiodol, which has the potential to change the way that infertility is managed from now on.
Data from this large, multi-centre, randomised controlled trial, known as H2Oil, was presented today at WCE2017 by Professor Ben Mol of the Robinson Research Institute, University of Adelaide, Australia .
The H2Oil study was conducted by Professor Mol together with Dr Kim Dreyer and Dr Velja Mijatovic from the Department of Reproductive Medicine, VU University Medical Centre, Amsterdam, and their multi-centre research team from 27 centres in the Netherlands. It is a powerful trial with 1,119 women undergoing investigation for infertility with a hysterosalpingogram (HSG) – the X-ray dye test of the fallopian tubes.
The women were randomised to a standard HSG with a water-soluble contrast medium (WSCM) versus an HSG with Lipiodol® Ultra-Fluid [LIPIODOL® Ultra-Fluid 480 Injection 10 mL, GUERBET]. In the standard HSG group the ongoing pregnancy rate 6 months after this HSG was 29%, whilst in the Lipiodol® Ultra-Fluid HSG group it was 40%, which was clearly statistically significant. There was no indication of consistent adverse events affecting either group.
Lipiodol® Ultra-Fluid is an Ethyl ester of iodinated fatty acids of poppy-seed oil injection; an oil-soluble contrast medium (OSCM) that has been used in radiology for several decades. It was long believed that testing a woman’s fallopian tubes could have fertility benefit through flushing the kind of debris from fallopian tubes that hinders fertility.
Research conducted in Auckland, New Zealand, by Professor Neil Johnson (also now of the Robinson Research Institute, as well as a fertility specialist at Repromed Auckland, and the President of WES) from 1999 onwards had strongly suggested a fertility benefit from Lipiodol® Ultra-Fluid – particularly amongst women with endometriosis, for whom the fertility benefit was shown to be dramatic . Also, the aggregate data of the smaller studies done before the H2Oil study (3 studies involving 382 women) indicated such a benefit .
This means that for every ten women undergoing an HSG to test their fallopian tubes, if Lipiodol® is used for that test, there will be one more pregnancy six months later and, consequently, one more baby nine months after that
said Professor Ben Mol – coincidentally himself a ‘Lipiodol® baby’ from the 1960s (when Lipiodol® Ultra-Fluid used to be used for the standard diagnostic test of tubal patency). Professor Mol, the leader of the Dutch study team, went on to say,
If we move to the use of Lipiodol® Ultra-Fluid for routine diagnostic tubal patency testing, more women will have a successful fertility outcome and will avoid the need for other expensive fertility treatments such as IVF. I believe that is justifiable at this point.
Whether Lipiodol® Ultra-Fluid is working through improving the environment where eggs are growing, the endometrial environment where the embryo is implanting, or simply, as we have always believed, through flushing the fallopian tubes, Lipiodol® Ultra-Fluid is a cost effective intervention that significantly improves a woman’s fertility.
Professional bodies responsible for guidelines, as well as funders of health care should consider recommending this intervention to infertile couples in good time before IVF is started. Of course, in our study a HSG also indicated the 2-3% with blocked tubes, that benefit from direct IVF.
Professor Neil Johnson, added:
Lipiodol® Ultra-Fluid has been offered as a treatment for infertility in New Zealand for more than a decade. It appears to be safe, the procedure is minimally-invasive and well tolerated by women, and has proved a popular alternative to more expensive and invasive fertility treatments.
Several hundred New Zealand babies have been born now thanks to Lipiodol®. The good news for women with endometriosis is that Lipiodol® Ultra-Fluid was identified as the innovative treatment with the most promising results six years ago in the World Endometriosis Society’s consensus meeting at the time of the 11th World Congress in Montpellier in 2011 .
This promise has been borne out, as it appears from our New Zealand studies that the use of Lipiodol® Ultra-Fluid is associated with a profound fertility improvement around four-fold for women with endometriosis.
This new study from our Dutch colleagues confirms beyond doubt the fertility value of Lipiodol® Ultra-Fluid.
- 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]
- Johnson NP, Farquhar CM, Hadden WE, Suckling J, Yu Y, Sadler L. The FLUSH Trial – Flushing with Lipiodol for Unexplained (and endometriosis-related) Subfertility by Hysterosalpingography: a randomised trial. Hum Reprod 2004;19:2043-51.
- Mohiyiddeen L, Hardiman A, Fitzgerald C, et al. Tubal flushing for subfertility. Cochrane Database Syst Rev 2015;5:CD003718.
- Johnson NP, Hummelshoj L, for The World Endometriosis Society Montpellier Consortium. Consensus on current management of endometriosis. Hum Reprod 2013;28(6):1552-68.