2University Department of Obstetrics and Gynaecology, Withington Hospital, Manchester M20 2LR, UK. Abstract. This study describes the introduction of ...
1996, The British Journal of Radiology, 69, 910-913
Hysterosalpingo-contrast sonography (HyCoSy) using Echovist' -200 in the outpatient investigation of infertility patients ^G AYIDA, 2P HARRIS, ?S KENNEDY, 2 M SEIF, 1 D BARLOW and ^ CHAMBERLAIN 1 2
Nuffield Department of Obstetrics and Gynaecology, Oxford Radcliffe Hospital, Oxford 0X3 9DU, and University Department of Obstetrics and Gynaecology, Withington Hospital, Manchester M20 2LR, UK Abstract This study describes the introduction of hysterosalpingo-contrast sonography (HyCoSy) as a first line outpatient investigation of uterine and tubal factors in two fertility units. 136 infertile women had transvaginal scanning before and during the intrauterine injection of contrast medium (Echovist®-200). HyCoSy was successfully completed in 132 cases (97%) within a mean time of 12.6 + 8.4 (4-50) min. The uterus and its cavity appeared normal in 108 (82%) women. Uterine abnormalities in the remaining 24 women (18%) included structural abnormality (n = 1), fibroids (n = 12) and endometrial polyps (n = 5). A total of 261 fallopian tubes in 132 women were assessed: 186 (71%) appeared patent and 55 (21%) blocked. The remaining 20 (8%) could not be assessed for technical reasons. Polycystic ovaries and ovarian cysts were diagnosed in eight women. The most common adverse effect was mild/moderate pain, similar to period pain, with 24 (18%) women requiring simple analgesia. HyCoSy is a simple and well tolerated outpatient procedure. The technique provides clinically valuable information about tubal patency, ovarian and uterine abnormalities.
An assessment of fallopian tubal patency is essential in the investigation of an infertile couple because tubal disease is a factor in approximately 20% of cases [ 1 ] . The most commonly used tests of tubal patency are X-ray hysterosalpingography (HSG) and laparoscopy with dye insufflation (L&D). The latter procedure is associated with both anaesthetic and surgical morbidity and a mortality rate of 1:12 500 [ 2 ] . Traditionally, the risks of laparoscopy have been justified by the yield of additional information concerning the presence of endometriosis, pelvic adhesions or other pelvic pathology provided by the procedure. However, a normal pelvis is found in many cases. Forman et al [3] reported that 40% of the women undergoing diagnostic laparoscopy for infertility in the Oxford fertility unit had an entirely normal pelvis. As it is now generally accepted that minimal/mild endometriosis does not warrant therapy [4, 5], if women with minimal/mild endometriosis and no other pathology in Forman's group are included as being normal then the proportion of normal pelves rises from 40% to 71%. Although laparoscopy is still recommended as the first line investigation of tubal patency in the Royal College of Obstetricians and Gynaecologists (RCOG) guidelines on the investigation of infertility, we believe tubal patency assessment should be achieved by using as simple a procedure as possible. L&D has been abandoned by some fertility units as a first line investigation [6, 7] and replaced by HSG. The disadvantages of HSG include extreme discomfort, a Accepted 27 June 1996. 910
need for radiological expertise and facilities, irradiation of the ovaries, and the possibility of allergic reactions to the contrast media. A simple alternative to HSG is hysterosalpingocontrast sonography (HyCoSy), utilizing an ultrasound contrast medium Echovist (Echovist 200®, Schering AG, Germany) and high resolution transvaginal scanning (TVS). Echovist is reported as being superior to saline in the assessment of tubal patency [8-10]. A high diagnostic reliability for HyCoSy has been reported [11-13] with concordance values of 80-90% when compared with HSG and L&D for tubal patency. These figures are superior to concordance values between X-ray HSG and L&D, the two current reference tests of tubal patency [14-16]. Experience of HyCoSy using Echovist is still limited. In the first reports [11,12], the procedure was performed under general anaesthesia which compromised the advantages of simplicity and cost effectiveness. We describe the introduction of HyCoSy as a first line outpatient test of tubal patency and uterine abnormality in two reproductive medicine centres. Materials and methods The study group consisted of 136 women who required exclusion of uterine and/or tubal factors as the cause of their infertility. The mean age was 32 + 4.9 years. 105 (77%) of the women were nulliparous. Women with a history of galactosaemia or active pelvic inflammatory disease were excluded from the study. Informed written consent was obtained from all the women. Approval for
The British Journal of Radiology, October 1996
HyCoSy: an outpatient infertility investigation
the study was obtained from the Hospitals' Ethics Committees. All HyCoSy examinations were performed between days 10-13 of the menstrual cycle. The examinations were performed using an Acuson 128-XP scanner (Mountain View, California, USA) with a 5 MHz vaginal probe (n = 81) or a Toshiba SSA 250A scanner (Tokyo, Japan) with a 6 MHz probe (n = 5) at Centre 1; and an ATL, UltraMark 9 HD scanner (Bothell, Washington, USA) with a 5 MHz probe (n = 50) at Centre 2. No analgesia was given prior to the procedure. Echovist was supplied as two components: a vial containing D-galactose microparticles (SHU 454 K, 3 g) and another containing 20% D-galactose carrier solution (SHU 454 M, 13.5 ml). The suspension was prepared by mixing the contents of both vials and vigorously shaking for 5 s. The homogenous milky-white suspension of highly echogenic microbubbles and galactose microparticles was then used within 5 min of mixing. Initial TVS determined the uterine position and any uterine or adnexal abnormality. The cervix was then cleansed with aqueous chlorhexidine solution. A size 5 or 7 French double lumen intrauterine catheter (Ackrad, Cranford, New Jersey) was inserted through the cervical os, the balloon being inflated with 1.5 ml of air for 5F and 2.5 ml for 7F. The Echovist suspension was injected in 1-2 ml boluses whilst continuously scanning. The uterine cavity was examined during its distension with Echovist. Tubal patency was ascertained by demonstrating flow along the entire length of the tube or by streaming at the cornual end for at least 10 s with spillage into the pouch of Douglas. The duration of the examination was timed from cleansing of the cervix to removal of the vaginal probe. All the procedures were recorded on video. After the procedure, the women were allowed home accompanied by a partner. All but two of the women (98%) were contacted by telephone after 24 h and asked to describe the incidence, severity and duration of any adverse effects. Pain levels were recorded as being mild, moderate and severe relative to their normal period pains. The women were advised to contact the investigators if any adverse effects occurred beyond the 24 h period. All the women were subsequently seen within 6 weeks in order to discuss further management of their infertility. Women with abnormal or inconclusive results were offered a diagnostic laparoscopy. During the initial learning phase, the validity of the technique was tested by performing L&D or HSG as well as HyCoSy in 34 cases.
(range 3-30) ml and the mean duration was 12.6 ±8.4 (range 4-50) min. The mean values for Centres 1 and 2, respectively, were 7.1 + 3.2 (range 3-15) ml and 13.3 + 4.4 (range 5-30) ml, and 7.4 ±3.5 (range 3-30) min and 21.3 ±6.9 (range 10-50) min. The uterus and its cavity were normal in appearance in 108 (82%) cases (Table I). In the remaining 24 (18%) cases, either a congenital anomaly (n = 7), fibroids (n — 12), or endometrial polyps (n = 5) were noted. Of the 261 fallopian tubes assessed for patency (three tubes were known to be absent), 186 (71%) appeared patent and 55 (21%) blocked. The remaining 20 (8%) tubes in 16 women could not be assessed because of technical difficulties in imaging which included marked retroversion of the uterus (n = 7), overlying bowel gas (n = 3), transducer positioning (n = 5), or cephalad displacement of the tubes beyond the depth of penetration of the vaginal probe (n = l). In two cases, abnormal adnexal masses were noted: a 10 cm diameter ovarian mass of mixed echogenicity and bilateral 4 cm diameter ovarian cysts suggestive of endometriomas. Polycystic ovaries were diagnosed in six women using accepted ultrasound criteria [17]. 31 women (60 tubes) had both HyCoSy and L&D and three women (six tubes) had both HSG and HyCoSy. Eight tubes were not assessed by HyCoSy for technical reasons. Of the 58 tubes assessed by two techniques there was an 84% concordance rate (Table II). The sensitivity of HyCoSy for detecting patent tubes was 89% (41/46), the specificity 67% (8/12), the positive predictive value 9 1 % (41/45) and the negative predictive value 6 1 % (8/13). The uterine abnormalities and ovarian cysts were all subsequently confirmed at laparoscopy with or without hysteroscopy. Additional pelvic pathology included minimal/mild endometriosis (n = 3>) and peritubal adhesions (n = 2). No analgesia was required during the procedure, although simple analgesia was taken prophylactically in 19 (14%) cases. In no case was the procedure abandoned because of pain. The most common adverse effect was mild or moderate pelvic discomfort (Table III), likened to period pains, which occurred in 75 (57%) women. 24 (18%) of these 75 women required non-steroidal analgesia for their discomfort within 24 h. Other less frequent adverse effects are listed in Table III. 130 women were available for follow-up (range 3-10 months) after HyCoSy. There were no recorded cases or suggestive histories of acute pelvic inflammatory disease. 17 (13%) women became pregnant, all within 6 months of the procedure.
Results 86 (63%) HyCoSy procedures were performed at Centre 1 and 50 (37%) at Centre 2. The examination was successfully completed in 132 (97%) of the women. In the remaining four cases the procedure was abandoned because either a tight nulliparous cervical os (n = 3) or previous laser treatment to the cervix (n — l) prevented insertion of the catheter. The mean volume of Echovist required was 9.4 + 4.7
Discussion We found HyCoSy using Echovist to be a simple outpatient procedure that can be performed by one operator with an assistant or chaperone. HyCoSy may be incorporated early into infertility investigation and provides important information on the uterus, its cavity and tubal patency. Concordance values of 84% in the subgroup of women who had both HyCoSy and L&D or HSG are in agreement with other published series
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G Ayida, P Harris, S Kennedy et al Table I. HyCoSy findings in 132 women Uterus (n= 132)
Ovaries (n = 264)
Patent
Non-patent
Non-assessable
Normal
Abnormal
Normal
Abnormal
186(71%)
55 (21%)
20 (8%)
108(82%)
24(18%) Fibroids n = 12 Polyps n = 5 Structural abnormality
249(94%)
15(6%) Cysts n — 3 Polycystic n= 12
Tubes (i, = 261)"
" Three tubes were absent. Table II. Comparison of findings in women who had HyCoSy and laparoscopy and dye insufrlation/HSG Laparoscopy (52 tubes), HSG (6 tubes) HyCoSy
Patent
Patent Non-patent Total
41 5 46
Non-patent 4 8 12
Total 45 13 58
[11-13] and testify to the accuracy of the technique. In two women, four tubes were patent at HyCoSy but not patent at laparoscopy (Table II). The non-patent findings at laparoscopy were unexplained, the tubes showing no filling and spillage despite looking completely normal together with the rest of the pelvis. It was considered that this was due to a failure of adequate cannulation, proximal block or tubal spasm at laparoscopy. In both instances Echovist had been seen to fill the uterus and streaming of the medium was clearly noted along the entire length of the tubes with spilling into the pouch of Douglas. One of these women subsequently underwent HSG which confirmed prompt bilateral tubal filling and spillage. Additional pelvic pathology detected at laparoscopy but missed by HyCoSy did not affect clinical management because (1) the adhesions (n = 2) were associated with tubal blockage on HyCoSy, so that a laparoscopy and dye insufflation would have been recommended, and (2) the endometriosis (« = 3) detected was of a minor degree and specific treatment was not indicated. As HyCoSy includes TVS of the pelvis, it has the added advantage over HSG of allowing assessment of
the endometrium [18] and myometrium, as well as the diagnosis of adnexal masses [19] and polycystic ovaries. Pelvic discomfort was the most commonly reported adverse effect (57%), requiring simple analgesia in only 24 cases (18%). The discomfort was described as less painful than period pains in over half the women. Adequate explanation prior to the procedure and demonstration of the findings during real-time scanning is very reassuring and probably increases the tolerance of the procedure. Similarly, injecting Echovist in small boluses and keeping the total volume injected to a minimum appears to reduce the likelihood of pelvic discomfort. An essential pre-requisite is adequate training and experience of TVS, as illustrated in the mean time taken and the volume of Echovist required in the two centres. In Centre 1, the consultant in charge of the Ultrasound Department, who was an experienced gynaecologist, performed or supervised all the procedures. In Centre 2, HyCoSy was carried out by a gynaecologist experienced in the clinical management of infertility and assisted reproduction. The use of selective salpingography catheters [7] or the addition of pulse wave or colour Doppler to B mode scanning when only a small segment of tube is visualized may, with increasing experience, reduce the number of non-assessable tubes [20-22]. This study confirms the suitability and feasibility of HyCoSy in the outpatient setting. HyCoSy is an acceptable procedure, avoiding the risks of surgery and irradiation. The advantage of HyCoSy as an early fertility screen may be in selecting out the low risk woman
Table III. Adverse effects during the procedure and in the following 24 h Adverse effect
No. of cases (%)
Length of time (n)
Action taken
Pelvic discomfort
75 (57%)
