Sonographic Hysterosalpingography: Oil vs Water Based Media (SHOW Trial) (NCT03604549) | Clinical Trial Compass
CompletedPhase 4
Sonographic Hysterosalpingography: Oil vs Water Based Media (SHOW Trial)
United States58 participantsStarted 2019-01-11
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.