A Comparative Study of Methods for Tubal Patency Determination and Uterine Cavity Evaluation: Sonography With the FemVue(TM) Catheter System vs. Hysterosalpingography (HSG)
A Comparative Study of Methods for Tubal Patency Determination and Uterine Cavity Evaluation: Sonography With the FemVue(TM) Catheter System vs. Hysterosalpingography (HSG)
Multi-center prospective comparison of fallopian tubal patency determination and uterine evaluation interventions using legally marketed devices for their intended purposes, and using each subject as their own control.
Study cancelled prior to recruitment.
Inclusion Criteria:
Non-pregnant women between the ages of 18 and 45 who desire to know the patency status of the fallopian tubes and if the uterine cavity is free of pathology who have:
Been attempting conception for 6 months or
A history of PID (including the conditions listed below) or
A history of pelvic surgery or
Advanced maternal age (≥ 35) And
Negative test for Gonorrhea/Chlamydia or prophylactic antibiotic treatment
Without current bi-lateral tubal sterilization
Signed Informed Consent
Exclusion Criteria:
Uterine anomaly or lesion(s) preventing catheter placement for either the FemVue or HSG procedure(as identified and documented by TVUS Screening procedure or the uterine cavity evaluation during the FemVue procedure or any previous diagnostic procedure)