An HSG with Lipiodol® Ultra Fluid is a simple & accurate procedure providing useful information on tubal patency & the uterine cavity.
Characterization of HSG findings
• Tubal abnormalities: tubal occlusion, salpingitis isthmica nodosum, polyps, hydrosalpinx, peritubal adhesions
• Uterine cavity abnormalities: congenital anomalies, polyps, leiomyomas, surgical changes, synechiae, adenomyosis, müllerian duct anomalies
New clinical evidence show that an HSG with Lipiodol® Ultra Fluid enhances pregnancy and live birth rates. 1-7
Wang R et al. 2019. Ultrasound Obstetric Gynecology
• Objective: To compare, in women with infertility, the effectiveness of tubal flushing using Oil-Soluble Contrast Medium (OSCM Lipiodol® Ultra Fluid) or Water-Soluble Contrast Medium (WSCM)
• Conclusion: «…In women with infertility undergoing fertility workup, tubal flushing using oil-based contrast medium probably increases clinical pregnancy rates within 6 months after randomization and may increase subsequent live-birth rates, compared with tubal flushing using water-based contrast medium and compared with no intervention…»
The New England Journal of Medicine. Dreyer K et al. 2017
• Objective: Evaluate the fertility enhancing effect of HSG with Oil-Soluble Contrast Medium (OSCM Lipiodol®) as compared to Water-Soluble Contrast Medium (WSCM Telebrix® Hystero)
• Multicenter randomized controlled trial; 1,108 infertile women randomized to HSG with OSCM (n=554) or WSCM (n=554)
• Conclusion: «…Rates of ongoing pregnancy and live births were higher among women who underwent hysterosalpingography with oil contrast than among women who underwent this procedure with water contrast...»
Human Reproduction. Johnson NP et al. 2004
Human Reproduction. Johnson NP et al. 2007
• Objective: Ascertain the effectiveness of Lipiodol® flushing for enhancing fertility
• Single centre, open parallel randomized controlled trial | 158 women randomized to HSG with Lipiodol® Ultra Fluid or to no intervention, stratified into 2 populations: 96 women without confirmed endometriosis and 62 women with endometriosis who had normal Fallopian tubes and ovaries
• Conclusion: «...Lipiodol® flushing is effective at enhancing fertility not only for women with endometriosis, but also for those with pure unexplained infertility…»
Results at 6 months: > Read the study
Results at 2 years: > Read the study
«…A systematic review of eight RCTs showed a significant increase in pregnancy rates with tubal flushing using oil-soluble contrast media when compared with no treatment… Tubal flushing with oil soluble contrast media was associated with an increase in the odds of live birth…[Evidence level 1a]…» 8
*Hierarchy of evidence: 1a – Systematic review and meta-analysis of randomised controlled trials
«…Hysterosalpingography (HSG), using either a water- or lipid-soluble contrast media, is the traditional and standard method for evaluating tubal patency and may offer some therapeutic benefit…» 10
«…Lipiodol® hysterosalpingogram improves live birth rates in women with endometriosis, but otherwise unexplained infertility, who are attempting natural conception…» 9
Consensus grading: γ (majority, 50 –80% agreed)
MISCARRIAGE, ECTOPIC PREGNANCY, INFECTION, HAEMORRHAGE
• No difference between Lipiodol® & Water-Soluble Contrast Media (WSCM) 1,2,6
INTRAVASATION & CLINICAL OIL EMBOLISM
• Asymptomatic contrast intravasation: reported rate 2-7% 1
• No case of clinical oil embolism reported in a meta-analysis from 2019 (n=3,852) & in a nation-wide survey from 2020 (n=3,289) 1,12
Precautions: Low instilled volume (9 mL*), monitoring under fluoroscopy & stopping instillation on first evidence of intravasation reliably avoid clinical complications 12-14
Contraindications: Patients with traumatic injuries, recent hemorrhage, recent pelvic surgery or vaginal/uterine bleeding 15
THYROID DYSFUNCTION
• Women undergoing HSG: 1 in 4 risk of transient subclinical hypothyroidism (clinical hypo/hyperthyroidism is exceptionally rare), when biochemically observed, no clinical consequences reported 16,17
• Babies born from mothers who underwent HSG: Retrospective data analysis of the H2Oil trial babies: None of the neonates conceived after HSG with Lipiodol® Ultra Fluid (n=76) or WSCM (n=64) had a positive screening result for congenital hypothyroidism | Japanese retrospective study: 2.4% of infants (n=214) tested positive during congenital hypothyroidism screening; their mothers received a median volume of 20 mL (range 10-20 mL), compared to 8 mL in the normal thyroid function group (range 3-25 mL) 18,19
Precautions: Thyroid function should be monitored after HSG particularly in patients with subclinical hypothyroidism; the dosage should be as low as possible to minimize the risk of fetal or neonatal thyroid dysfunction
Contraindication: Women with confirmed hyperthyroidism
• After HSG: Pain reported less frequently with Lipiodol® 6
* WSCM: Water soluble Contrast Medium
• Significantly increased pregnancy & live birth rates as compared to water-soluble contrast medium 1-7
• Accurate image quality and simultaneous visualization of the Fallopian tubes & uterine cavity 20-22
• Simple & well-tolerated, less frequent post-procedural pain 2,6,12,20,21
The site is not country specific and may vary from the approved product information in the country where you are located. Please refer to the local prescribing information and Summary of Product Characteristics (SmPC). Some products mentioned in this website may not be registered, nor commercially available in all countries. Please contact your local Guerbet representative.
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. Mohiyiddeen L et al. Tubal flushing for subfertility. Cochrane Database Syst Rev. 2015 May 1;(5):CD003718.
7. Izumi G et al. Oil-Soluble Contrast Medium (OSCM) for hysterosalpingography modulates dendritic cell and regulatory T cell profiles in the peritoneal cavity: a possible mechanism by which OSCM enhances fertility. J Immunol. 2017 Jun 1;198(11):4277-84.
8. National Institute for Health and Clinical Excellence (NICE): guidance. Fertility: assessment and treatment for people with fertility problems. Feb 2013. Ref: 213280.
9. Johnson NP & Hummelshoj L. World Endometriosis Society Montpellier Consortium. Consensus on current management of endometriosis. Hum Reprod. 2013 Jun;28(6):1552-68.
10. Practice Committee of the American Society for Reproductive Medicine. Diagnostic evaluation of the infertile female: a committee opinion. Fertil Steril. 2015 Jun;103(6):e44-50.
11. Canadian Fertility & Andrology Society. CFAS consensus document for the investigation of infertility by first line physicians. Aug 2002.
12. Roest I et al. Complications after hysterosalpingography with oil- or water-based contrast: results of a nationwide survey. Hum Reprod Open. 2020 Jan 15;2020(1):hoz045.
13. Bateman BG et al. Intravasation during hysterosalpingography using oil-base contrast media. Fertil Steril. 1980 Nov;34(5):439-43.
14. Soules MR et al. Oil versus aqueous media for hysterosalpingography: a continuing debate based on many opinions and few facts. Fertil Steril. 1982 Jul;38(1):1-11.
15. Chalazonitis A et al. Hysterosalpingography: technique and applications. Curr Probl Diagn Radiol. 2009 Sep-Oct;38(5):199-205.
16. Mekaru K et al. Thyroid function after hysterosalpingography using an oil-soluble iodinated contrast medium. Gynecol Endocrinol. 2008;24:498-501.
17. So S et al. The effect of oil and water-soluble contrast medium in hysterosalpingography on thyroid function. Gynecol Endocrinol. 2017 Sep;33(9):682-685.
18. Satoh M et al. Thyroid dysfunction in neonates born to mothers who have undergone hysterosalpingography involving an oil-soluble iodinated contrast medium. Hormone Research in Paediatrics, 2015; 84: 370-375.
19. Van Welie et al. Thyroid function in neonates conceived after hysterosalpingography with iodinated contrast. Hum Reprod. 2020 May 1;35(5):1159-1167.
20. Lindequist S et al. Diagnostic quality and complications of hysterosalpingography: oil- versus water-soluble contrast media-a randomized prospective study. Radiology. 1991 Apr;179(1):69-74.
21. Lindequist S et al. Use of iotrolan versus ethiodized poppy-seed oil in hysterosalpingography. Radiology. 1994 May;191(2):513-7.
22. de Boer AD et al. Oil or aqueous contrast media for hysterosalpingography: a prospective, randomized, clinical study. Eur J Obstet Gynecol Reprod Biol. 1988 May;28(1):65-8.