UK approves Lipiodol® Ultra Fluid for hysterosalpingography in women undergoing infertility workup

UK approves Lipiodol® Ultra Fluid for hysterosalpingography in women undergoing infertility workup

Guerbet (GBT) has been granted approval for an indication extension in the United Kingdom, where Lipiodol® Ultra Fluid is the only oil-based contrast medium indicated for hysterosalpingography (HSG) in women undergoing infertility workup. In addition, clinical evidence showing that an HSG with Lipiodol® Ultra Fluid enhances pregnancy rates has been included in the pregnancy fertility and lactation section of the product (Section 4.6) following licence extension approval by UK’s Medicines and Healthcare products Regulatory Authority (MHRA). The licence extension is a demonstration of Lipiodol Ultra Fluid® utility in fertility management.1,2,3,4,5,6

One in seven couples face fertility issues in the UK.The fertility workup, during which HSG is performed, is a key step in patient care management.

The technique involves the slow infusion of Lipiodol® Ultra Fluid into the uterus, using x-ray monitoring to assess the uterine cavity and tubes.

“This is great news for UK patients experiencing difficulties conceiving, as it brings them additional hope by enhancing their chances of falling pregnant at an early stage of their fertility journey. As with any procedure patients should be aware of any associated risks”, said Gwenda Burns, Chief Executive of Fertility Network UK.

“At Imperial College Healthcare NHS Trust, we have performed more than 10,000 HSGs over the last few decades. The evidence-based results from the H2Oil study encouraged our HSG and fertility teams to use Lipiodol® Ultra Fluid for HSG in selected patients. After several months of use, we can confirm that an HSG with Lipiodol® Ultra Fluid is an exciting and valuable technique in the management of patients being investigated for fertility issues in our centre. Our teams at Imperial College Healthcare NHS Trust will soon to be involved as investigators in on-going randomised controlled clinical trials evaluating the performance of Lipiodol® Ultra Fluid for HSG in extended populations undergoing fertility workup“, said Prof. Anne Hemingway (Imperial College Healthcare NHS Trust, London).

The United Kingdom is the sixth European country to grant approval for HSG in women undergoing infertility workup after Ireland, Hungary, the Netherlands, the Czech Republic and Denmark. Lipiodol® Ultra Fluid is also currently approved for HSG in ten additional countries (USA, including Puerto Rico, Canada, Argentina, Turkey, South-Africa, Japan, Taiwan, Thailand, Australia and New Zealand).

In 2016, the Guerbet Group launched its Women’s Health franchise with the ambition to improve the quality of infertility management and breast cancer surgery (www.guerbet.com/products-solutions/women-s-health/).

 

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] 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.

[3] 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.

[4] Wang R et al. Effectiveness on fertility outcome of tubal flushing with different contrast media: systematic review and network meta-analysis. Ultrasound Obstet Gynecol. 2019 Aug;54(2):172-181.

[5] Fang F et al. Oil-based versus water-based contrast for hysterosalpingography in infertile women: a systematic review and meta-analysis of randomized controlled trials. Fertil Steril. 2018 Jul 1;110(1):153-160.e3.

[6] Erratum. Fertil Steril. 2019 Jun;111(6):1262.

[7] van Rijswijk J et al. Tubal flushing with oil-based or water-based contrast at hysterosalpingography for infertility: long-term reproductive outcomes of a randomized trial. Fertil Steril. 2020 Jul;114(1):155-162.

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