ExEm Foam Kit
J Clin Med. 2021 Sep; 10(18): 4169.
Published online 2021 Sep 15. doi: 10.3390/jcm10184169
Diagnostic Accuracy Study Comparing Hysterosalpingo-Foam Sonography and Hysterosalpingography for Fallopian Tube Patency Assessment
Imaging diagnostics are an essential part of contemporary medicine. Ultrasound-based examination plays a special role in gynecology and its use has been increasing, particularly in the evaluation of infertility. Traditionally, the cornerstones of investigation for an infertile couple have been grouped into several testing categories, with the evaluation of uterine architecture and tubal patency being one of the most important ones [1]. Tubal abnormalities are seen in 25–35% of female subfertility patients [1]. Tubal disease encompasses a range of pathologies, with pelvic inflammatory disease (PID) as the most common cause; it is usually asymptomatic, and its main causal agent is Chlamydia trachomatis [2]. Other possible causes of tubal infertility are endometriosis, previous pelvic surgery, fibroids and pelvic tuberculosis [3].
Laparoscopy with chromopertubation (LC) is the gold-standard technique for tubal assessment, but because it is an invasive, expensive and riskier technique [1,4] it was replaced by HSG, which has been used for decades. This latter procedure has lower diagnostic accuracy than LC [5], is unable to detect abnormal ovaries or myometrium and involves radiation exposure, discomfort or even abdominal pain [6]. Considering the disadvantages of HSG, hysterosalpingo-contrast sonography (HyCoSy) was introduced as an alternative for outpatient tubal assessment as it avoids the previously mentioned risks. HyCoSy, using a mixture of air and saline solution, has an accuracy comparable to that of HSG [7], allows the real-time observation of the pelvic organs through ultrasound and it performs better than HSG when detecting abnormalities in the uterine cavity [8]. However, HyCoSy is more operator-dependent than the two other techniques. At this point, it is important to highlight that all these methods have technical limitations, so scientific societies recommend further evaluation with a second technique in case of abnormal results to establish a correct diagnosis and find the best treatment strategy for the patient [1].
Different contrast media have been proven effective but have become no longer available for different reasons [9]. In 2007, a non-embryotoxic gel known as ExEm® gel (GynaecologIQ, Delft, The Netherlands) was developed. Because ultrasound scans (US) of good-quality at an acceptable price were obtained, hysterosalpingo-foam sonography (HyFoSy) has been established as a safe and less painful alternative and has become widely adopted in infertility clinics and outpatient settings, shortening waiting times for treatment initiation [10]; moreover, its feasibility, tolerability and safety have been already demonstrated [11,12,13].
The ability to perform most infertility diagnoses by ultrasound in the ambulatory setting is not only attractive and beneficial to patients, but also to the healthcare system. Thus, the objective of this study is to estimate the diagnostic accuracy of HyFoSy in tubal patency testing and compare it to the accuracy of traditional HSG for establishing a new diagnostic strategy in infertility treatment.