Hysterosalpingo contrast sonography (HyCoSy) with SH U 454 (Echovist) for the assessment of tubal patency.

Human Reproduction vol.13 no.11 pp.3049–3052, 1998 Hysterosalpingo contrast sonography (HyCoSy) with SH U 454 (Echovist®) for the assessment of tubal patency Marcos M.Reis1, Sergio R.Soares, Marcelo L.Cancado and Aroldo F.Camargos Servico de Reproducao Humana do Hospital das Clinicas da Universidade Federal de Minas Gerais, avenida Alfredo Balena, 110, 90 andar, Belo Horizonte – MG – Brazil, Cep 30 150 260 1To whom correspondence should be addressed at: 420 East 70th Street Apt 2K New York, NY 10021, USA A total of 88 Fallopian tubes from 44 patients was examined with hysterosalpingo contrast sonography (HyCoSy), hysterosalpingogram (HSG), and laparoscopic chromopertubation (LC) in order to assess their relative accuracy for measuring tubal patency. HyCoSy was done by transvaginal ultrasound and the contrast was SH U 454 (Echovist®). The flow of multiple fractions of the contrast medium through each Fallopian tube was observed in real time in appropriate imaging planes by means of a transvaginal probe. Compared with laparoscopic results, we found a sensitivity of 85.2%, a specificity of 85.2%, a positive predictive value (PPV) of 71.9%, a negative predictive value (NPV) of 92.9% and concordance (HyCoSy/LC) of 85.2%, while the corresponding values for HSG were sensitivity J 85.2%, specificity J 83.6%, PPV J 69.7%, NPV J 92.7% and concordance (HSG/LC) of 84.1%. Compared with HSG results, HyCoSy obtained a copositivity of 66.7%, a co-negativity of 81.8% and a concordance of 76.1%. In conclusion, HyCoSy with SH U 454 proved to be a reliable and safe modality for evaluating tubal patency; it is suitable as an outpatient diagnostic procedure to be used before more invasive procedures. Key words: Fallopian tube patency/HyCoSy/infertility/transvaginal ultrasound Introduction Between 8 and 20% of couples of reproductive age are infertile, according to various epidemiological studies (Barad, 1991; WHO, 1993). The main causes of infertility are male factor, ovulatory and tubal disorders. Tubal disorder is the most frequent female factor, occurring in up to 35% of infertile women (Cates et al., 1991). It is a consequence of pelvic inflammatory disease, endometriosis, pelvic surgery, ectopic pregnancy, appendicitis with peritonitis and septic abortion. Traditionally, hysterosalpingography (HSG) and laparoscopy and dye have been used to assess tubal function. Hysterosalpingo contrast sonography (HyCoSy) with contrast medium has been used for such a purpose (Deichert et al., 1989; Schlief and Deichert, 1991). It consists of endovaginal ultrasonography © European Society of Human Reproduction and Embryology with concomitant instillation of an ecogenic contrast medium into the uterine cavity, using a catheter inserted in the uterine cavity through the cervical os. It has been demonstrated that HSG and HyCoSy have the same accuracy at detecting tubal patency (Campbell et al., 1994; Heikkimen et al., 1995). HyCoSy, however, offers a number of benefits over HSG as a diagnostic test: the uterine cavity is better evaluated by HyCoSy; there is no risk of anaphylaxis since there is no iodide contrast; it is a less expensive test and causes less pain; there is no radiation exposure; and it can be conducted by the reproduction specialist themselves, at their office, allowing a dynamic study of the patient’s pelvis (Schlief and Deichert, 1991; Deichert et al., 1992; Campbell et al., 1994). The main purpose of this study was to evaluate the accuracy of HyCoSy in the assessment of tubal patency with regards to HSG and laparoscopy and dye (gold standard). Materials and methods Patients After our preliminary experience with hysterosonography (Reis et al., 1997), we examined a total of 88 Fallopian tubes from 44 patients with HyCoSy. Samples came from a consecutive series of patients who presented with inability to conceive after 2 years of intercourse without contraception and whose male partners had not shown severe impaired sperm parameters. Altogether, 88 Fallopian tubes were examined with HyCoSy, HSG, and laparoscopy and dye (LC). The study was performed according to the Helsinki guidelines and after approval by the Ethic Committee of Hospital das Clinicas of the Universidade Federal de Minas Gerais (UFMG). Written informed consent was obtained from all patients. Conditions Exclusion criteria included active pelvic inflammatory disease, galactosaemia, pregnancy, age ,18 years and women whose male partners had had oligospermia (sperm count ,33106). Clinical findings and laboratory parameters confirmed the criteria. The diagnostic procedures (HyCoSy and HSG) were performed in the first half of the cycle without anaesthesia and laparoscopy and dye was carried out under general anaesthesia. HyCoSy A standard transvaginal ultrasound examination was followed by transvaginal HyCoSy with SH U 454 (Echovist®; Schering AG, Berlin, Germany), a galactose microparticle/air microbubble suspension. After the uterine cavity had been filled with Ringer’s solution via the ZUI (Zinnanti Uterine Injector, Chatsworth, CA, USA) catheter, the contour of the uterus was evaluated for the presence or absence of leiomyoma, polyp, malformations or synechiae. After that, the Echovist suspension was injected in 1–2 ml boluses whilst scanning continuously. The flow of multiple fractions of the contrast 3049 M.M.Reis et al. medium (SH U 454) through each Fallopian tube was observed in real time in appropriate imaging planes by means of a transvaginal probe (Figure 1). If drainage into the tube was unimpeded, the echogenic fluid formed a narrow white line within the tube and flow was seen on real-time. No echogenic fluid was seen within occluded segments of the tube, while a hydrosalpinx was seen as a collection of echogenic fluid in the lateral portion of the tube. Each tube was examined as far as the infundibulum as well as in the region around the ovary, to demonstrate echogenic fluid spilling into the peritoneum. In patients with bilateral tubal occlusion, distension of the uterine cavity was seen without demonstration of echogenic fluid in the tubes; this phenomenon is not usually seen in cases of unilateral tubal occlusion because the fluid drains via the patent side. Antibiotic therapy was given for patients who presented pathological findings at HyCoSy procedure. Sample size Hulley (Hulley and Cummings, 1988) considers the studies with diagnostic procedures such as descriptive study, suggesting the following formula for sample size: n 5 (4 * Z α2 * P * (1 – P))/W2 n 5 sample size; Zα 5 (1 – α) 5 (1 – 0.05) 5 1.96; P 5 expected proportion; W 5 total width confidence interval. Selecting the confidence level for the 95% interval, the sample size varies according to sensitivity and specificity of the test and total width of confidence interval desired for the test (Hulley and Cummings, 1988). In our pilot study, we obtained a sensitivity of 100% and specificity of 91.7% and in published studies (Schlief and Deich (...truncated)