Trial Outcomes & Findings for Sonographic Hysterosalpingography: Oil vs Water Based Media (SHOW Trial) (NCT NCT03604549)
NCT ID: NCT03604549
Last Updated: 2022-05-02
Results Overview
8 week viable intrauterine pregnancy
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
58 participants
Primary outcome timeframe
within 6 months of Sono HSG procedure
Results posted on
2022-05-02
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sonographic Hysterosalpingography: Oil vs Water Based Media (SHOW Trial)
Baseline characteristics by cohort
| Measure |
Saline
n=24 Participants
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
|
Lipiodol UF
n=24 Participants
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
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.6 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
31.0 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
30.3 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Multi-racial
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
BMI
|
30.3 kg/m2
STANDARD_DEVIATION 7.3 • n=5 Participants
|
31.8 kg/m2
STANDARD_DEVIATION 8.9 • n=7 Participants
|
31.0 kg/m2
STANDARD_DEVIATION 8.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: within 6 months of Sono HSG procedure8 week viable intrauterine pregnancy
Outcome measures
| Measure |
Saline
n=24 Participants
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
|
Lipiodol UF
n=24 Participants
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
|
|---|---|---|
|
Ongoing Pregnancy Rate
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: After sono hystersalpingography study infusion/procedure completedscale ranges from 0-10 with a higher score indicating more pain
Outcome measures
| Measure |
Saline
n=24 Participants
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
|
Lipiodol UF
n=24 Participants
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
|
|---|---|---|
|
Procedural Related Pain Assessed by Visual Analog Scale
|
3.5 units on a scale
Standard Deviation 2.7
|
3.5 units on a scale
Standard Deviation 2.9
|
Adverse Events
Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lipiodol UF
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Saline
n=24 participants at risk
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
|
Lipiodol UF
n=24 participants at risk
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
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Cervical ectopic hemorrhage
|
0.00%
0/24 • 6 months
|
4.2%
1/24 • Number of events 1 • 6 months
|
Additional Information
Richard S. Legro, M.D., Principal Investigator
Penn State Health Milton S. Hershey Medical Center
Phone: 717-531-6210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place