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Lipiodol UF for Infertility

Phase 4
Waitlist Available
Led By Richard Legro, M.D.
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 months of sono hsg procedure
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

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.

Eligible Conditions
  • Infertility

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6 months of sono hsg procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 months of sono hsg procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ongoing Pregnancy Rate
Secondary study objectives
Procedural Related Pain Assessed by Visual Analog Scale

Side effects data

From 2021 Phase 4 trial • 58 Patients • NCT03604549
4%
Cervical ectopic hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lipiodol UF
Saline

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lipiodol UFExperimental Treatment1 Intervention
Women in this arm will receive a flush with Lipiodol UF after normal saline Sono HSG.
Group II: SalinePlacebo Group1 Intervention
Women in this arm will receive a flush with saline after normal saline Sono HSG.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lipiodol UF
2019
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
510 Previous Clinical Trials
2,796,416 Total Patients Enrolled
1 Trials studying Infertility
25 Patients Enrolled for Infertility
GuerbetIndustry Sponsor
70 Previous Clinical Trials
94,523 Total Patients Enrolled
Richard Legro, M.D.Principal InvestigatorPenn State University and Milton S. Hershey Medical Center
5 Previous Clinical Trials
210 Total Patients Enrolled
~8 spots leftby Nov 2025
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