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

Therapeutic Effect of Sonographic Hysterosalpingography: Oil vs Water Based Media

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: Saline; Drug: Lipiodol UF

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline; Women in this arm will receive a flush with saline after normal saline Sono HSG.	Drug: Saline; Up to 10cc of saline will be infused via intrauterine catheter
Experimental: Lipiodol UF; Women in this arm will receive a flush with Lipiodol UF after normal saline Sono HSG.	Drug: Lipiodol UF; Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter; Other Names: Lipiodol Ultra Fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing Pregnancy Rate	8 week viable intrauterine pregnancy	within 6 months of Sono HSG procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: Guerbet
• Investigators: Principal Investigator: Richard Legro, M.D., Penn State University and Milton S. Hershey Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2019
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): August 25, 2021

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Antineoplastic Agents; Ethiodized Oil
• Other Study ID Numbers: 00008466

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No