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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lipiodol UF
Saline
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Saline

Lipiodol UF

Arm Description

Women in this arm will receive a flush with saline after normal saline Sono HSG.

Women in this arm will receive a flush with Lipiodol UF after normal saline Sono HSG.

Outcomes

Primary Outcome Measures

Ongoing Pregnancy Rate
8 week viable intrauterine pregnancy

Secondary Outcome Measures

Procedural Related Pain Assessed by Visual Analog Scale
scale ranges from 0-10 with a higher score indicating more pain

Full Information

First Posted
July 10, 2018
Last Updated
April 4, 2022
Sponsor
Milton S. Hershey Medical Center
Collaborators
Guerbet
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1. Study Identification

Unique Protocol Identification Number
NCT03604549
Brief Title
Sonographic Hysterosalpingography: Oil vs Water Based Media (SHOW Trial)
Official Title
Therapeutic Effect of Sonographic Hysterosalpingography: Oil vs Water Based Media
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
August 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
Guerbet

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Women in this arm will receive a flush with saline after normal saline Sono HSG.
Arm Title
Lipiodol UF
Arm Type
Experimental
Arm Description
Women in this arm will receive a flush with Lipiodol UF after normal saline Sono HSG.
Intervention Type
Drug
Intervention Name(s)
Lipiodol UF
Other Intervention Name(s)
Lipiodol Ultra Fluid
Intervention Description
Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Up to 10cc of saline will be infused via intrauterine catheter
Primary Outcome Measure Information:
Title
Ongoing Pregnancy Rate
Description
8 week viable intrauterine pregnancy
Time Frame
within 6 months of Sono HSG procedure
Secondary Outcome Measure Information:
Title
Procedural Related Pain Assessed by Visual Analog Scale
Description
scale ranges from 0-10 with a higher score indicating more pain
Time Frame
After sono hystersalpingography study infusion/procedure completed

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Legro, M.D.
Organizational Affiliation
Penn State University and Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33053612
Citation
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.
Results Reference
derived

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

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