Sonographic Hysterosalpingography: Oil vs Water Based Media (SHOW Trial)

Summary

Performing fluoroscopic HSG with oil based contrast medium has been shown to increase pregnancy rates in a subfertile population. This is a pilot study to test the efficacy of as well as the tolerability and safety of using lipid based oil medium for sonographic based hysterosalpingography (Sono HSG) compared to water based contrast (i.e. normal saline) for women seeking fertility. The double blind study will randomize 56 women at the time of Sono HSG in a 1:1 ratio to receive through the SHG catheter either up to 10 cc of Lipiodol UF® or normal saline. The investigators will collect subjective pain experience and follow the subjects for 6 months after the test for pregnancy and collect all adverse events during and after the procedure.

Timeline

Start

2019-01-11

Primary completion

2021-05-31

Completion

2021-08-25

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry analysis (superiority test); Saline vs Lipiodol UF; p = 0.10; Risk Ratio (RR) 0.44 (95% CI 0.16 to 1.25); Chi-squared reads as missed primary endpoint NCT03604549 ↗

release “In the trial, an HSG performed with Lipiodol ® Ultra Fluid significantly increased pregnancy and live birth rates as compared to an HSG performed with a water-based contrast medium.” reads as met primary endpoint guerbet.com ↗

release “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.” reads as met primary endpoint guerbet.com ↗

Publications

• Wang R, Watson A, Johnson N, Cheung K, Fitzgerald C, Mol BWJ, Mohiyiddeen L. Tubal flushing for subfertility. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD003718. doi: 10.1002/14651858.CD003718.pub5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lipiodol UF	Diagnostic / imaging agent	10 ml	Other

Indications