Sonographic Hysterosalpingography: Oil vs Water Based Media (SHOW Trial)

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03604549
• Collaborator: Guerbet (Industry)
• Enrollment: 58
• Location: 1
• Arms: 2
• Actual Duration (Months): 31.4
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Lipiodol UF; Drug: Saline	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Therapeutic Effect of Sonographic Hysterosalpingography: Oil vs Water Based Media
• Actual Study Start Date: Jan 11, 2019
• Actual Primary Completion Date: May 31, 2021
• Actual Study Completion Date: Aug 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Saline Women in this arm will receive a flush with saline after normal saline Sono HSG.	Drug: Saline; Up to 10cc of saline will be infused via intrauterine catheter
Experimental: Lipiodol UF Women in this arm will receive a flush with Lipiodol UF after normal saline Sono HSG.	Drug: Lipiodol UF; Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter; Other Names: Lipiodol Ultra Fluid

Outcome Measures

Primary Outcome Measures

1. Ongoing Pregnancy Rate [within 6 months of Sono HSG procedure]

   8 week viable intrauterine pregnancy

Secondary Outcome Measures

1. Procedural Related Pain Assessed by Visual Analog Scale [After sono hystersalpingography study infusion/procedure completed]

   scale ranges from 0-10 with a higher score indicating more pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Milton S. Hershey Medical Center
• Guerbet

Investigators

• Principal Investigator: Richard Legro, M.D., Penn State University and Milton S. Hershey Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 7, 2021

More Information

Publications

None provided.

• Responsible Party: Richard S. Legro, M.D., Interim Chair and Vice Chair of Research, Department of Obstetrics and Gynecology, Professor of Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT03604549
• Other Study ID Numbers: 00008466
• First Posted: Jul 27, 2018
• Last Update Posted: May 2, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Infertility; Ethiodized Oil

Study Results

Participant Flow

Arm/Group Title	Saline	Lipiodol UF
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	29	29
COMPLETED	24	24
NOT COMPLETED	5	5

Baseline Characteristics

Arm/Group Title	Saline	Lipiodol UF	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	24	24	48
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.6 (3.9)	31.0 (5.4)	30.3 (4.7)
Sex: Female, Male (Count of Participants)
Female	24 100%	24 100%	48 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	21 87.5%	20 83.3%	41 85.4%
Asian	0 0%	2 8.3%	2 4.2%
Multi-racial	3 12.5%	1 4.2%	4 8.3%
Unknown	0 0%	1 4.2%	1 2.1%
BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	30.3 (7.3)	31.8 (8.9)	31.0 (8.1)

Outcome Measures

1. Primary Outcome

Title	Ongoing Pregnancy Rate
Description	8 week viable intrauterine pregnancy
Time Frame	within 6 months of Sono HSG procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Saline	Lipiodol UF
Arm/Group Description	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	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
Measure Participants	24	24
Count of Participants [Participants]	9 37.5%	4 16.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Saline, Lipiodol UF
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.10
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.44
	Confidence Interval	(2-Sided) 95%; 0.16 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lipiodol UF is the numerator and Saline is the denominator for RR

2. Secondary Outcome

Title	Procedural Related Pain Assessed by Visual Analog Scale
Description	scale ranges from 0-10 with a higher score indicating more pain
Time Frame	After sono hystersalpingography study infusion/procedure completed

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Saline	Lipiodol UF
Arm/Group Description	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	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
Measure Participants	24	24
Mean (Standard Deviation) [units on a scale]	3.5 (2.7)	3.5 (2.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Saline, Lipiodol UF
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.96
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; -1.59 to 1.68
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference reported as Lipiodol UF - Saline

Adverse Events

Time Frame	6 months
Arm/Group Title	Saline		Lipiodol UF
Arm/Group Description	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		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
All Cause Mortality
	Saline		Lipiodol UF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)
Serious Adverse Events
	Saline		Lipiodol UF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Saline		Lipiodol UF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		1/24 (4.2%)
Pregnancy, puerperium and perinatal conditions
Cervical ectopic hemorrhage	0/24 (0%)	0	1/24 (4.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.