FemVue and Tubal Patency
Stopped early · Not applicable
Conditions studied: Tubal Patency
In brief
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.
Key facts
- Study ID
- NCT01880073
- Run by
- Weill Medical College of Cornell University
- People needed
- 24
- Starts
- 2012-05-01
- Expected to finish
- 2019-05-24
- Last updated by the study team
- 2020-05-27
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Pts ages 18-45 undergoing planned diagnostic laparoscopy with chromopertubation.
You may not qualify if…
- Adnexal mass > 3.5cm or uterine size greater than 10 wks
Where it is running
- Weill Cornell Medical College — New York, New York, United States
Full record on ClinicalTrials.gov
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