InfertilityPhase 4NCT03604549
Sonographic Hysterosalpingography: Oil vs Water Based Media (SHOW Trial)
A Phase 4 study testing Lipiodol UF and Saline in people with Infertility, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Lipiodol UF and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2019to 25 Aug 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Therapeutic Effect of Sonographic Hysterosalpingography: Oil vs Water Based Media
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.
- Conditions
- Infertility
- Being tested
- Lipiodol UF, Saline
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipiodol UFDrug
Also called Lipiodol Ultra Fluid
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
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Women in this arm will receive a flush with saline after normal saline Sono HSG. Receives: Drug: Saline |
| Lipiodol UF | Experimental | Women in this arm will receive a flush with Lipiodol UF after normal saline Sono HSG. Receives: Drug: Lipiodol UF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing Pregnancy Rate
8 week viable intrauterine pregnancy
Measured: within 6 months of Sono HSG procedure
Secondary outcomes (1)
Procedural Related Pain Assessed by Visual Analog Scale
scale ranges from 0-10 with a higher score indicating more pain
Measured: After sono hystersalpingography study infusion/procedure completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start11 Jan 2019
- Primary completion31 May 2021
- Study completion25 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet
- Responsible party
- Principal investigator, Richard S. Legro, M.D., Milton S. Hershey Medical Center
- Investigators
- Richard Legro, M.D., Principal investigator, Penn State University and Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604549
- Sponsor's protocol ID
- 00008466
- Status last verified
- Apr 2022
- First submitted
- 10 Jul 2018
- Last updated
- 2 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33053612
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Sonographic Hysterosalpingography: Oil vs Water Based Media
- ClinicalTrials.gov ID
- NCT03604549
- Acronym / sponsor ID
- 00008466
- Conditions
- Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Guerbet
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Posted 24 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Drug: SalineWomen in this arm will receive a flush with saline after normal saline Sono HSG. |
| Lipiodol UF | Experimental | Drug: Lipiodol UFWomen in this arm will receive a flush with Lipiodol UF after normal saline Sono HSG. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipiodol UFAlso: Lipiodol Ultra FluidUp to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter | Drug | Lipiodol UF |
| SalineUp to 10cc of saline will be infused via intrauterine catheter | Drug | Saline |
Primary outcome
Ongoing Pregnancy Rate
Time frame: within 6 months of Sono HSG procedure
8 week viable intrauterine pregnancy
1 secondary outcome
Procedural Related Pain Assessed by Visual Analog Scale
Time frame: After sono hystersalpingography study infusion/procedure completed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33053612Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Legro, M.D. principal investigator
Penn State University and Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lipiodol UF and Saline in people with Infertility, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing Pregnancy Rate (time frame: within 6 months of Sono HSG procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03604549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.