Infertility
Conditions
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.
Interventions
DRUGLipiodol UF
Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter
DRUGSaline
Up to 10cc of saline will be infused via intrauterine catheter
Sponsors
Guerbet
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing Pregnancy Rate | within 6 months of Sono HSG procedure | 8 week viable intrauterine pregnancy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 24 |
| 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 | 24 |
| Total | 48 |
Baseline characteristics
| Characteristic | Saline | Lipiodol UF | Total |
|---|---|---|---|
| Age, Continuous | 29.6 years STANDARD_DEVIATION 3.9 | 31.0 years STANDARD_DEVIATION 5.4 | 30.3 years STANDARD_DEVIATION 4.7 |
| BMI | 30.3 kg/m2 STANDARD_DEVIATION 7.3 | 31.8 kg/m2 STANDARD_DEVIATION 8.9 | 31.0 kg/m2 STANDARD_DEVIATION 8.1 |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Multi-racial | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Unknown | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Female | 24 Participants | 24 Participants | 48 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 1 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
Primary
Ongoing Pregnancy Rate
8 week viable intrauterine pregnancy
Time frame: within 6 months of Sono HSG procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Saline | Ongoing Pregnancy Rate | 9 Participants |
| Lipiodol UF | Ongoing Pregnancy Rate | 4 Participants |
p-value: 0.195% CI: [0.16, 1.25]Chi-squared
Secondary
Procedural Related Pain Assessed by Visual Analog Scale
scale ranges from 0-10 with a higher score indicating more pain
Time frame: After sono hystersalpingography study infusion/procedure completed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saline | Procedural Related Pain Assessed by Visual Analog Scale | 3.5 units on a scale | Standard Deviation 2.7 |
| Lipiodol UF | Procedural Related Pain Assessed by Visual Analog Scale | 3.5 units on a scale | Standard Deviation 2.9 |
p-value: 0.9695% CI: [-1.59, 1.68]t-test, 2 sided