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

NCT03604549 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-05-02

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Guerbet

    collaborator INDUSTRY

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Richard Legro, M.D. · Penn State University and Milton S. Hershey Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-11
Primary Completion
2021-05-31
Completion
2021-08-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03604549 on ClinicalTrials.gov