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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-11

Study Completion Date

2021-08-25

Brief Summary

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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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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Saline

Women in this arm will receive a flush with saline after normal saline Sono HSG.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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 HSG.

Group Type EXPERIMENTAL

Lipiodol UF

Intervention Type DRUG

Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter

Interventions

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Lipiodol UF

Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter

Intervention Type DRUG

Saline

Up to 10cc of saline will be infused via intrauterine catheter

Intervention Type DRUG

Other Intervention Names

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Lipiodol Ultra Fluid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No