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NCT Number: NCT03604549

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lipiodol UF

Drug

Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter

Other names: Lipiodol Ultra Fluid

Saline

Drug

Up to 10cc of saline will be infused via intrauterine catheter

Primary outcomes

  1. Ongoing Pregnancy Rate

    Time frame: within 6 months of Sono HSG procedure

    8 week viable intrauterine pregnancy

Secondary outcomes

  1. Procedural Related Pain Assessed by Visual Analog Scale

    Time frame: After sono hystersalpingography study infusion/procedure completed

    scale ranges from 0-10 with a higher score indicating more pain

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Guerbet

Registry information

Official study title

Therapeutic Effect of Sonographic Hysterosalpingography: Oil vs Water Based Media

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 27, 2018
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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