FemVue and Tubal Patency

Study Overview
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Brief Summary
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A thorough infertility evaluation commonly involves determining whether a woman's fallopian tubes are patent. The two most often utilized methods of evaluating the fallopian tubes are hysterosalpingogram (taking an X-ray of the pelvis after injecting dye through the uterus and fallopian tubes) and laparoscopic chromopertubation (a surgical procedure in which dye is visualized passing through the fallopian tubes). The FemVue Saline-Air device is a new method of assessing tubal patency. The device utilizes a mixture of saline and air bubbles that can be seen passing through the fallopian tubes by ultrasound. FemVue can be efficiently performed in a physician's office and is minimally invasive. Unlike hysterosalpingogram and laparoscopic chromopertubation, it does not carry the risks of anesthesia or surgery, and doesn't expose the patient to radiation or contrast. It does, like the other two methods, carry a small risk of infection. This study will involve using the FemVue device on patients under anesthesia in the operating room before they undergo scheduled laparoscopic chromopertubation, the gold standard for evaluating tubal patency. The two methods will be compared to determine the accuracy of the FemVue device.

Detailed Description
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Subjects who agree to participate will have their tubes evaluated by using the FemVue Saline-Air device and laparoscopic chromopertubation.

Official Title
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Use of FemVue for Assessment of Tubal Patency as Compared to Laparoscopic Chromopertubation

Conditions
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Tubal Patency

Intervention / Treatment
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* Device: FemVue device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pts ages 18-45 undergoing planned diagnostic laparoscopy with chromopertubation. Exclusion Criteria: Adnexal mass > 3.5cm or uterine size greater than 10 wks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FemVue device<br>FemVue would be used in conjunction with the laparoscopic chromopertubation to determine if it is as effective. | Device: FemVue device<br>* The device will be used in conjunction with what is now considered the standard of care to determine if it's as effective.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Had Concordant Findings | When the findings using the device was the same as the procedure. In other words, if the device found tubes to be patent (open) and it was confirmed with the laparoscopic chromopertubation, the findings are said to be concordant the same as if the device found tubes to be blocked and the laparoscopic chromopertubation found the same. | End of procedure, day 1. | 
| Number of Subjects With Discordant Findings | When the findings between the FemVue and Laparoscopic Chromopertubation were discordant, efficacy of FemVue was determined with a third procedure, a Hysterosalpingogram. If the FemVue device found the tubes patent (open) and laparoscopic chromopertubation found them closed, the finding is considered discordant. To determine which finding is accurate a third procedure was performed which is a Hysteropsalpingogram, another way to determine tubal patency. | End of procedure, day 1. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Time Frame in Which Patency of the Tubes Was Determined With the FemVue Device. |  | 10 mins after start of procedure | 
| Time Frame in Which Patency of the Tubes Was Determined by Laparoscopic Chrompertubation. |  | End of procedure, Day 1 |