Therapeutic Effect of Sonographic Hysterosalpingography: Oil vs Water Based Media
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Ongoing Pregnancy Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Saline
Women in this arm will receive a flush with saline after normal saline Sono HSG.
Intervention: Saline (Drug)
Lipiodol UF
Women in this arm will receive a flush with Lipiodol UF after normal saline Sono HSG.
Intervention: Lipiodol UF (Drug)
Outcomes
Primary Outcomes
Ongoing Pregnancy Rate
Time Frame: within 6 months of Sono HSG procedure
8 week viable intrauterine pregnancy
Secondary Outcomes
- Procedural Related Pain Assessed by Visual Analog Scale(After sono hystersalpingography study infusion/procedure completed)
Investigators
Richard S. Legro, M.D.
Interim Chair and Vice Chair of Research, Department of Obstetrics and Gynecology, Professor of Obstetrics and Gynecology and Public Health Sciences
Milton S. Hershey Medical Center