CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 58 enrolled
Drug / intervention
Lipiodol UF +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03604549
NCT03604549Phase 4Completed

Therapeutic Effect of Sonographic Hysterosalpingography: Oil vs Water Based Media

Milton S. Hershey Medical Center·interventional·Posted Jul 27, 2018·Updated May 2, 2022

In Brief

A Phase 4 clinical trial evaluating Lipiodol UF and Saline for Infertility. Completed, enrolled 58 participants across 1 site.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility
CountriesUnited States
CollaboratorsGuerbet

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJul 27, 2018
Enrollment StartJan 11, 2019
Primary CompletionMay 31, 2021
Study CompletionAug 25, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.9 years ago

Interventions

Lipiodol UFdrug

Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter

Salinedrug

Up to 10cc of saline will be infused via intrauterine catheter