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

Study Overview
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Brief Summary
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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.

Official Title
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Therapeutic Effect of Sonographic Hysterosalpingography: Oil vs Water Based Media

Conditions
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Infertility

Intervention / Treatment
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* Drug: Lipiodol UF
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |