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NCT03604549 · ClinicalTrials.gov registry record · Phase 4
Sonographic Hysterosalpingography: Oil vs Water Based Media (SHOW Trial)
A Phase 4 study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 58
- Enrollment target
NCT03604549 is a Phase 4 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 58 participants.
The verdict
NCT03604549, a Phase 4 study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 58 participants
- Enrollment target
Study 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.
Interventions
- DRUG Saline
- DRUG Lipiodol UF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2019-01-11 |
| Est. Completion | 2021-08-25 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03604549
The ClinicalTrials.gov registry entry for NCT03604549 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT03604549 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03604549 about?
NCT03604549 is a clinical study titled "Sonographic Hysterosalpingography: Oil vs Water Based Media (SHOW Trial)". 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...
What is the current status of trial NCT03604549?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 58 participants. The study started on 2019-01-11. Estimated completion is 2021-08-25.
What interventions are being tested in trial NCT03604549?
The interventions under investigation include: Saline (DRUG), Lipiodol UF (DRUG).
Who is sponsoring clinical trial NCT03604549?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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