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

Infertility Clinical Trial

Official title:

Therapeutic Effect of Sonographic Hysterosalpingography: Oil vs Water Based Media

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604549
• Other study ID #: 00008466
• Status: Completed
• Phase: Phase 4
• Start date: January 11, 2019
• Est. completion date: August 25, 2021

Study information

• Verified date: April 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 25, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Eligible for Sono HSG for fertility testing
• In good general health
• Willing and capable of complying with the study procedures
• At least one patent tube and no endometrial pathology on Sono HSG
• Ready to undergo infertility treatment immediately after the test
• Not planning on IVF therapy in the next 6 mos

Exclusion Criteria:

• Known tubal or endometrial (polyp, submucous fibroid, etc.) pathology
• At high risk for tubal disease due to history of Pelvic Inflammatory Disease
• Known hypersensitivity to Lipiodol UF®or known allergy to iodine containing contrast media or shellfish
• Endometrial pathology on Sono HSG requiring further evaluation (as per the performing physician)
• Bilateral tubal occlusion on Sono HSG
• Unable to tolerate potential pain associated with the study.
• Requiring IVF due to severe male factor, known pelvic adhesions, etc.
• Couples with decreased male factor fertility rate (i.e., low sperm count or motility, i.e. less than 5 million/mL concentration on semen analysis

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Lipiodol UF
Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter
• Saline
Up to 10cc of saline will be infused via intrauterine catheter

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Guerbet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing Pregnancy Rate	8 week viable intrauterine pregnancy	within 6 months of Sono HSG procedure
Secondary	Procedural Related Pain Assessed by Visual Analog Scale	scale ranges from 0-10 with a higher score indicating more pain	After sono hystersalpingography study infusion/procedure completed