Clinical trial NCT03604549: Sonographic Hysterosalpingography: Oil vs Water Based Media (SHOW Trial)
Official title: Therapeutic Effect of Sonographic Hysterosalpingography: Oil vs Water Based Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Guerbet
First posted: 2018-07-27
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Ongoing Pregnancy Rate
timeFrame: within 6 months of Sono HSG procedure
Secondary outcomes:
measure: Procedural Related Pain Assessed by Visual Analog Scale
timeFrame: After sono hystersalpingography study infusion/procedure completed
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State University and Milton S. Hershey Medical Center
name: Richard Legro, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang R, Watson A, Johnson N, Cheung K, Fitzgerald C, Mol BWJ, Mohiyiddeen L. Tubal flushing for subfertility. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD003718. doi: 10.1002/14651858.CD003718.pub5.