Objective
The objective of the study was to assess the accuracy of hysterosalpingo-contrast sonography (HyCoSy) in establishing tubal patency or blockage and evaluating the uterine cavity by comparing it with hysteroscopy laparoscopy (HLC) or hysterosalpingography (HSG).
Study Design
This study was a chart review evaluating infertility patients and patients who had undergone hysteroscopic sterilization who underwent both HyCoSy and HLC or HyCoSy and HSG at private offices associated with university hospitals. Sensitivity, specificity, positive predictive value, and negative predictive value of HyCoSy were calculated.
Results
HyCoSy compared with HLC had a sensitivity of 97% and specificity of 82%, and HyCoSy compared with HSG was 100% concordant. Uterine cavities evaluated by sonohysterography and hysteroscopy were 100% concordant.
Conclusion
HyCoSy is accurate in determining tubal patency and evaluating the uterine cavity, suggesting it could supplant HSG not only as the first-line diagnostic test in an infertility workup but also in confirming tubal blockage after hysteroscopic sterilization.
The evaluation of the fallopian tubes and the endometrial cavity is an essential part of the infertility workup. Currently this is done either by hysterosalpingography (HSG) or at the time of hysteroscopy and laparoscopy with chromopertubation (HLC). HLC is considered the gold standard for assessing the integrity of the uterine cavity and for establishing tubal status. It allows the physician to diagnose and treat the problem. When compared with HLC, HSG has been reported to have a sensitivity of 72-85% and a specificity of 68-89% in diagnosing tubal patency. HSG is also currently required to confirm tubal blockage 3 months after hysteroscopic tubal sterilization.
Hysterosalpingo-contrast sonography (HyCoSy) uses positive ultrasound-enhancing contrast media with transvaginal ultrasound to assess the status of the fallopian tubes, as well as the uterine cavity, by means of conventional sonohysterography. It can be performed in the gynecologist’s office, in which it is more convenient for the patient and the gynecologist. Initial studies used air and saline as the contrast agent, with or without Doppler, but further studies began using ultrasound-dedicated contrast media. The air bubbles and microbubbles of these first-generation agents diffuse very quickly, leading to a short duration of visualization of the contrast fluid, making the test more difficult and requiring greater operator experience to obtain consistently reliable results.
Second-generation agents, such as Sonovue (BR-1, sulfur hexafluoride; Bracco International BV, Amsterdam, The Netherlands) and Definity (MRX-115, perflutren lipid microspheres; Bristol Myers-Squibb Medical Imaging, North Billerica, MA), use gases with less diffusibility and solubility and have a longer duration of visualization, allowing for easier evaluation of the tubal course. However, bowel gas and hyperechoic signals coming from pelvic organs may interfere with the signals from these newer contrast media.
To minimize interference from other pelvic organs, a special ultrasound software (contrast-tuned imaging [CnTI] Biosound ESAOTE, Indianapolis, IN), which picks up only the sound waves from the contrast medium and ignores surrounding structures, has been developed. With the CnTI technology, the course of the contrast fluid is followed as a white band in a black background flowing from the endometrial cavity into the fallopian tubes and the dark peritoneal cavity. Although CnTI technology is not required to perform HyCoSy, it has been shown to have better accuracy in determining tubal patency. However, in a previous study using Sonovue, only small numbers of tubes were evaluated by both HyCoSy and HLC, and less accuracy on tubal occlusion was reported. Although Sonovue is not approved by the Food and Drug Administration (FDA) for use in the United States, a similar contrast media, Definity, is FDA approved and currently indicated for intravenous infusion during echocardiography, although it is not currently indicated for HyCoSy.
The aim of this study was to assess the accuracy of HyCoSy using CnTI technology and Definity contrast media in the evaluation of the fallopian tubes and the endometrial cavity by comparing it with HLC or HSG.
Materials and Methods
Following the introduction of HyCoSy and CnTI technology in the 2 US centers (Center for Fertility and Women’s Health, New Britain, CT, and the University of Texas Southwestern Medical Center, Fort Worth, TX), data were collected on all patients (200) who underwent HyCoSy from July 2007 through December 2009. Both US centers are accredited by the American Institute of Ultrasound in Medicine.
Patients were included in this study if they had a HyCoSy as part of an infertility evaluation and then had either an HSG or an HLC (if surgery was indicated for the treatment of endometriosis, pelvic adhesions, uterine malformations, or fibroids).
Patients who were scheduled for HSG, to confirm tubal blockage after hysteroscopic tubal sterilization, were consented to undergo a HyCoSy, as well as an HSG. Institutional review board approval was obtained at both institutions at which these procedures and this study were conducted. The patients were not compensated for their participation, and the costs of the HyCoSy were offset by the clinic.
HyCoSy was performed as previously described. Definity contrast media was activated by agitation in a dental shaker for 45 seconds. One milliliter of Definity media was mixed with 9 mL of injectable sterile normal saline in a 10 mL syringe. After cleaning the patients’ cervix with betadine, a 5 French HSG catheter (Rocket Medical, Hingham, MA) was placed inside the cervix into the lower uterine cavity and the catheter balloon was inflated.
Transvaginal ultrasound was performed using an EC1239-3 vaginal probe on the Biosound ESAOTE Technos MPX ultrasound machine to visualize the uterus, the ovaries, and the proper placement of the HSG catheter. CnTI software was activated while Definity solution was being injected through the catheter into the uterine cavity. The hyperechoic bubbles were visualized on the screen as they filled the endometrial cavity and followed the course of the tubes from each cornua, around the ipsilateral ovary, and into the peritoneal cavity when the tubes were patent. When the tubes were blocked, the contrast advanced to the point of blockage, as shown in Figure 1 , A and B. When the tubal evaluation was completed, the media were switched to normal saline, the balloon of the catheter was deflated, and 10-30 mL of saline was infused to evaluate the uterine cavity in the usual fashion of sonohysterography.
