NCT03604549

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

Therapeutic Effect of Sonographic Hysterosalpingography: Oil vs Water Based Media

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Lipiodol UF	Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter
DRUG	Saline	Up to 10cc of saline will be infused via intrauterine catheter

Timeline

• Start date: 2019-01-11
• Primary completion: 2021-05-31
• Completion: 2021-08-25
• First posted: 2018-07-27
• Last updated: 2022-05-02
• Results posted: 2022-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study