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

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: Lipiodol UF; Drug: Saline

• Registration Number: NCT03604549
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-07-20
• Study First Posted: 2018-07-27
• Study Start: 2019-01-11
• Primary Completion: 2021-05-31
• Study Completion: 2021-08-25
• Results First Submitted: 2022-02-03
• Results First Submitted QC: 2022-02-03
• Results First Posted: 2022-02-24
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Ongoing Pregnancy Rate	within 6 months of Sono HSG procedure	8 week viable intrauterine pregnancy

Secondary Outcome Measures

Name	Time	Method
Procedural Related Pain Assessed by Visual Analog Scale	After sono hystersalpingography study infusion/procedure completed	scale ranges from 0-10 with a higher score indicating more pain

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States