OBJECTIVE: To compare the efficiency of air-filled albumin microspheres (Infoson) with saline solution in determining Fallopian tube patency during hysterosalpingo contrast sonography (HyCoSy). METHODS: This was a prospective randomized multicenter study with a sequential design. Over a 10-month period, 23 patients (mean age, 33 years) referred for infertility were examined byHyCoSy (saline or Infoson) before conventional hysterosalpingography (Iopamiron 370), performed during the same session. Contrast agents were administered through a 5-F Ackrad balloon catheter inserted transcervically into the uterine cavity. HyCoSy was performed with a 7-MHz transvaginal probe using both B-mode and color Doppler, and tubal patency was demonstrated by the appearance of contrast agent in the peritoneal cavity near the ovaries. Data were registered for each patient during the examination and the results were monitored by sequential analysis. RESULTS:Mean volumes of contrast injections were 35.3 mL of saline, 14.4 mL of Infoson, and 13.8 mL of Iopamiron 370. Infoson-enhanced HyCoSy provided a significantly larger (P = 0.006) number of correct diagnoses (20/22 Fallopian tubes) than did saline HyCoSy (12/24 Fallopian tubes), and the same number as that achieved by hysterosalpingography. CONCLUSION: A positive ultrasound contrast agent appears to be more efficient than saline solution at determining Fallopian tube patency in infertile women by means of HyCoSy, and as efficient as an iodinated contrast agent in the same population explored by HSG. HyCoSy could be used to screen infertile women, thereby avoiding the use of iodinated contrast medium and exposure to ionizing radiation during conventional HSG in patients with patent Fallopian tubes.
RCT Entities:
OBJECTIVE: To compare the efficiency of air-filled albumin microspheres (Infoson) with saline solution in determining Fallopian tube patency during hysterosalpingo contrast sonography (HyCoSy). METHODS: This was a prospective randomized multicenter study with a sequential design. Over a 10-month period, 23 patients (mean age, 33 years) referred for infertility were examined by HyCoSy (saline or Infoson) before conventional hysterosalpingography (Iopamiron 370), performed during the same session. Contrast agents were administered through a 5-F Ackrad balloon catheter inserted transcervically into the uterine cavity. HyCoSy was performed with a 7-MHz transvaginal probe using both B-mode and color Doppler, and tubal patency was demonstrated by the appearance of contrast agent in the peritoneal cavity near the ovaries. Data were registered for each patient during the examination and the results were monitored by sequential analysis. RESULTS: Mean volumes of contrast injections were 35.3 mL of saline, 14.4 mL of Infoson, and 13.8 mL of Iopamiron 370. Infoson-enhanced HyCoSy provided a significantly larger (P = 0.006) number of correct diagnoses (20/22 Fallopian tubes) than did saline HyCoSy (12/24 Fallopian tubes), and the same number as that achieved by hysterosalpingography. CONCLUSION: A positive ultrasound contrast agent appears to be more efficient than saline solution at determining Fallopian tube patency in infertilewomen by means of HyCoSy, and as efficient as an iodinated contrast agent in the same population explored by HSG. HyCoSy could be used to screen infertilewomen, thereby avoiding the use of iodinated contrast medium and exposure to ionizing radiation during conventional HSG in patients with patent Fallopian tubes.