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

Penn State Health

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: Saline; Drug: Lipiodol UF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03604549

00008466

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline

Lipiodol UF

Experimental group

Description:

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

Treatment:

Drug: Lipiodol UF