New York, New York 10065


Purpose:

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.


Study summary:

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


Criteria:

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


NCT ID:

NCT01880073


Primary Contact:

Principal Investigator
Steven Spandorfer, MD
Weill Medical College of Cornell University

Mitasha C. Joseph, RN, MPA
Phone: 646-962-3382
Email: mij2008@med.cornell.edu


Backup Contact:

Email: res2011@med.cornell.edu
Rodriq E. Stubbs, NP
Phone: 646-962-3276


Location Contact:

New York, New York 10065
United States

Mitasha C Joseph, RN, MPA
Phone: 646-962-3382
Email: mij2008@med.cornell.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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