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Ηysterosalpingo-contrast sonography (HyCoSy)

The assessment of fallopian tube patency is an important part of the investigation of the subfertile woman. Tubal pathology accounts for 30–40% of female infertility. The gold standard method for evaluating the tubes is the injection of methylene blue through the cervix during laparoscopy, followed by confirmation of tubal patency through visualization of dye spill from the fimbrial ends. However, because this method is invasive and costly, it has largely been replaced in daily clinical practice by conventional hysterosalpingography (HSG), whose main disadvantages are exposure to ionizing radiation and pain caused during the passage of the contrast medium.

Image: conventional hysterosalpingography (HSG)

To overcome these disadvantages, hysterosalpingo-contrast sonography (HyCoSy) using contrast medium/saline with air was introduced as an alternative method, with diagnostic accuracy rates comparable to the two previous methods. However, the contrast agents previously used (Echovist – Schering AG, Berlin & SonoVue – Bracco, Milan) were withdrawn from the market and replaced by ExEm-gel foam (hydroxyethyl cellulose and glycerol, IQ Medical Ventures BV, Rotterdam, The Netherlands) mixed with water. The technique is now referred to as HyFoSy. ExEm-foam has a viscosity of 270 cP and contains 94.12% water, making it fluid enough to pass through the fallopian tubes while remaining stable for at least 5 minutes and sufficiently echogenic for ultrasound visualization. Finally, it is safe and well tolerated, without the adverse effects associated with the contrast agents previously used.

Image: Catheter and the device
Image : The technique of insertion of catheter

Diagnostic Value and Adverse Effects

The first prospective study comparing HSG and the HyFoSy technique demonstrated tubal patency in 78% of women, while 7% had tubal obstruction confirmed by HSG, and another 7% showed discordant diagnoses between the two methods. In another observational comparative study involving 20 cases, there was 100% agreement between HyFoSy and laparoscopy findings. In a randomized study of 37 women including HyFoSy, HyCoSy (saline and air), and laparoscopy, diagnostic agreement between HyFoSy and laparoscopy was 94%, while agreement between HyCoSy and laparoscopy was 57.8%.

Finally, in a prospective observational study including the High Definition Flow (HDF) Doppler technique, comparison of HyCoSy and HyFoSy findings with laparoscopy demonstrated agreement rates of 84.2% and 92.1% respectively, while the addition of HDF Doppler to HyFoSy increased agreement to 95.8%. The conclusion from all studies is that the method demonstrates high sensitivity. Particularly noteworthy is the very high negative predictive value of HyCoSy and HyFoSy, with or without HDF Doppler, for tubal obstruction (99.6%, 99.5%, and 99% respectively), meaning that when tubal obstruction is not identified, there is almost complete agreement with the final diagnosis.

 

In all studies, adverse effects, including pain during the procedure, were minimal. All authors concluded that diagnosing tubal patency is easier, whereas diagnosing obstruction is less reliable because of false-positive findings caused by mucus or tubal spasm. Their conclusion was that HyFoSy is diagnostic for tubal patency only and not for tubal obstruction, which still requires confirmation by HSG or laparoscopy.

3D Ultrasonography and Doppler Techniques

With HyCoSy using saline and air, the contrast medium remains in the tubes for only a short time, and it is difficult to visualize the entire course of the tube in a single section. Therefore, the technique of 3D ultrasonography with coded contrast imaging (3D U/S CCI) was introduced, allowing visualization of both fallopian tubes along their entire length in a reproducible manner.

Furthermore, in HyFoSy, where the foam is more stable and remains longer within the tubes, 3D U/S CCI offers additional imaging advantages.

 

Studies comparing sections obtained with 3D U/S CCI demonstrated results equivalent to those obtained with 2D ultrasound imaging. In a randomized study of 17 women who underwent laparoscopic tubal patency assessment followed by 2D and 3D HyFoSy, the findings agreed with laparoscopy in 81% and 88% of cases respectively. Specificity and sensitivity were 80% and 92% for 2D imaging, and 98% and 91.4% for 3D imaging. Moreover, the 3D technique was faster, less painful, and allowed post-examination reconstruction of the acquired images.

In the most recent and largest meta-analysis comparing 2D and 3D imaging, 30 studies were included (23 studies with 2D-HyCoSy, 6 with 3D/4D-HyCoSy, and 2 comparing both techniques). The sensitivity and specificity of 2D-HyCoSy were 86% and 94%, while for 3D-HyCoSy they were 95% and 89% respectively. No statistically significant difference was found between the two methods, although the meta-analysis was considered of moderate quality due to study heterogeneity.

Discomfort and Pain

Intrauterine administration of contrast agents may cause discomfort and pain due to cervical dilation by the catheter, uterine distension by the contrast medium (prostaglandin release), the composition of the medium itself, or a combination of factors.

Among 483 patients who underwent HyCoSy with a pediatric balloon catheter, 30% reported no pain, 49.7% mild pain, 13.5% moderate pain, and 6.8% severe pain, while 4.9% experienced vasovagal symptoms.

Regarding HyFoSy, five studies have reported significantly less pain compared with conventional hysterosalpingography. However, all studies involved balloon catheters, which still caused low-intensity pain (VAS scale), and none used the catheter marketed in Greece by the manufacturing company.

In the largest recent multicenter study involving 915 patients undergoing HyFoSy, very low failure rates (0.95%) due to cervical stenosis were reported, along with high patient tolerance, mostly mild pain (60%), and very few minor complications (2 vasovagal episodes and 1 cystitis case).

Regarding the type and temperature of the contrast medium, foam has not yet been extensively studied. Nevertheless, the lower intracavitary pressure generated by foam compared with other contrast media appears to make it more tolerable. Thus, all studies concerning pain and discomfort conclude that HyCoSy and HyFoSy are much less painful imaging techniques, and prophylactic analgesia is generally unnecessary, although antispasmodic medication may have a role.

Venous Intravasation

Passage of contrast medium through the myometrium into the uterine venous network is a known complication of hysterosalpingography, occurring in 6.4% of cases. In studies using HyCoSy, the incidence of intravasation was 13.4%, with higher risk associated with thin endometrium and high injection pressure, and lower risk when the examination was performed 5–7 days after the end of menstruation.

Regarding HyFoSy, although one case of intravasation has been reported, it is considered a safer method because the foam components (hydroxyethyl cellulose and glycerol) are safe even for intravenous administration.

Prevention of Pelvic Inflammatory Disease

From hysterosalpingography we know that only patients with pre-existing hydrosalpinx are at increased risk for pelvic inflammatory disease and therefore require prophylactic antibiotic therapy. Furthermore, the glycerol used in HyFoSy has antimicrobial and antiviral properties.

Increased Probability of Pregnancy Achievement?

To date, only observational studies have evaluated pregnancy rates after tubal patency testing using HyFoSy.

In one retrospective study, pregnancy rates reached 55%, especially during the cycle of examination and the following two cycles. In subsequent studies, pregnancy rates reached 43.2%, with half occurring spontaneously within six months, while another study reported spontaneous conception in 19.2% within three months.

Finally, in the most recent study, Exacoustos et al. reported spontaneous conception rates of 10.2% during the first month, 29.9% within six months, and 34.4% within twelve months.

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