Ultrasound in the investigation of tubal patency. A meta-analysis of three comparative studies of Echovist-200 including 1007 women.
METHODS
This study is a meta-analysis of the results of three clinical studies of the ultrasound echo-contrast agent Echovist-200 with transvaginal contrast sonography (HyCoSy) in the demonstration of tubal patency. Results from 1007 patients were included in the analysis, of whom 986 patients were examined for tubal patency. The HyCoSy findings were compared with those of chromolaparoscopy in 428 cases and with those of hysterosalpingography (HSG) in 202.


RESULTS
The results of HyCoSy and chromolaparoscopy were identical in 294 of 428 patients (68.7%) or in 688 of 828 individual tubes (83.1%). HyCoSy showed "false" occlusion in 85 tubes (10.3%) and "false" patency in 55 (6.7%). The results of HyCoSy and HSG were identical in 138 of 202 patients (68.3%) or in 320 of 384 individual tubes (83.3%). HyCoSy showed "false" occlusion in 49 tubes (12.8%) and "false" patency in 15 (3.9%). The findings of chromolaparoscopy and HSG agreed in 49 of 77 patients (63.6%) or in 116 of 152 tubes (76.3%). HSG showed "false" occlusion in 19 (12.5%) tubes and "false" patency in 17 (11.2%).
Echovist-200 was well tolerated. The most frequent adverse event was pain, which was mild in 42.3% of patients and severe in 10.1%. Pain was clearly related to tubal occlusion. Other adverse events such as vasovagal reactions or nausea occurred in 7.0% of patients, but the events required treatment in only 1.9%.
Holz
K
K
Clinical Development Diagnostics, Ultrasound Contrast Media, Schering AG Berlin, Germany.
Becker
R
R
Schürmann
R
R
D002986:Clinical Trials as Topic; D003287:Contrast Media; D019160:Endosonography; D005184:Fallopian Tube Diseases / Q000000981:diagnostic imaging*; D005186:Fallopian Tube Patency Tests; D005260:Female; D006801:Humans; D007047:Hysterosalpingography; D007247:Infertility, Female / Q000000981:diagnostic imaging*; D010535:Laparoscopy; D011134:Polysaccharides; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity
D003287:Contrast Media; D011134:Polysaccharides; C040642:SHU 454