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| Name | Class |
|---|---|
| Guerbet | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline | Placebo Comparator | Women in this arm will receive a flush with saline after normal saline Sono HSG. |
|
| Lipiodol UF | Experimental | Women in this arm will receive a flush with Lipiodol UF after normal saline Sono HSG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipiodol UF | Drug | Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing Pregnancy Rate | 8 week viable intrauterine pregnancy | within 6 months of Sono HSG procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Related Pain Assessed by Visual Analog Scale | scale ranges from 0-10 with a higher score indicating more pain | After sono hystersalpingography study infusion/procedure completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Legro, M.D. | Penn State University and Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33053612 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Saline | Women in this arm will receive a flush with saline after normal saline Sono Hystersalpingography. . Saline: Up to 10cc of saline will be infused via intrauterine catheter |
| FG001 | Lipiodol UF | Women in this arm will receive a flush with Lipiodol UF after normal saline Sono Hystersalpingography. Lipiodol UF: Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline analysis population represents subjects having study agent administered during sono HSG procedure
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| ID | Title | Description |
|---|---|---|
| BG000 | Saline | Women in this arm will receive a flush with saline after normal saline Sono HSG. Saline: Up to 10cc of saline will be infused via intrauterine catheter |
| BG001 | Lipiodol UF |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ongoing Pregnancy Rate | 8 week viable intrauterine pregnancy | Posted | Count of Participants | Participants | within 6 months of Sono HSG procedure |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saline | Women in this arm will receive a flush with saline after normal saline Sono HSG. Saline: Up to 10cc of saline will be infused via intrauterine catheter |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cervical ectopic hemorrhage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard S. Legro, M.D., Principal Investigator | Penn State Health Milton S. Hershey Medical Center | 717-531-6210 | rsl1@psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2021 | Feb 3, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Drug | Up to 10cc of saline will be infused via intrauterine catheter |
|
Women in this arm will receive a flush with Lipiodol UF after normal saline Sono HSG.
Lipiodol UF: Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Procedural Related Pain Assessed by Visual Analog Scale | scale ranges from 0-10 with a higher score indicating more pain | Posted | Mean | Standard Deviation | units on a scale | After sono hystersalpingography study infusion/procedure completed |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Lipiodol UF | Women in this arm will receive a flush with Lipiodol UF after normal saline Sono HSG. Lipiodol UF: Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter | 0 | 24 | 0 | 24 | 1 | 24 |
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| D017670 |
| Sodium Compounds |