FemVue and Tubal Patency
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/6/2019 |
| Start Date: | May 2012 |
| End Date: | May 31, 2020 |
| Contact: | Mitasha C. Joseph, RN, MPA |
| Email: | mij2008@med.cornell.edu |
| Phone: | 646-962-3382 |
Use of FemVue for Assessment of Tubal Patency as Compared to Laparoscopic Chromopertubation
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.
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.
Subjects who agree to participate will have their tubes evaluated by using the FemVue
Saline-Air device and laparoscopic chromopertubation.
Saline-Air device and laparoscopic chromopertubation.
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
We found this trial at
1
site
New York, New York 10021
Principal Investigator: Glenn Schattman, MD
Phone: 646-962-3382
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