Color Doppler hysterosalpingography in the diagnosis of tubal patency

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1 FERTILITY AND STERILITY Copyright" 1996 American Society for Reproductive Medicine Printed on acid free paper in U. S. A. Color Doppler hysterosalpingography in the diagnosis of tubal patency Cesare Battaglia, M.D.*t Paolo G. Artini, V.D.:!: Gerardo D'Ambrogio, M.D.:!: Alessandro D. Genazzani, M.D.* Andrea R. Genazzani, M.D.:!: Annibale Volpe, M.D.* University School of Medicine of Modena, Modena and University School of Medicine of Pisa, Pisa, Italy Objective: To assess tubal patency by color Doppler hysterosalpingography (HSG). Design: Comparative study of color Doppler HSG with roentgenogram HSG and chromolaparoscopy in infertile women of childbearing age. Setting: Clinical environment. Patients: Sixty female patients (22 to 39 years) with long-lasting infertility problems. Intervention: Sterile saline was transcervically injected into the uterine cavity through a catheter and color Doppler HSG was performed. All the patients were submitted to roentgenogram HSG and chromolaparoscopy. Main Outcome Measures: The diagnostic efficacy of color Doppler HSG and its concordance with "gold standard" chromolaparoscopy were analyzed. Results: Correlation between color Doppler HSG and roentgenogram HSG with chromolaparoscopy occurred in 86% versus 93% of all women studied. Conclusions: Color Doppler HSG with its accuracy and safety results a promising alternative technique to roentgenogram HSG in diagnosing tubal status in infertile patients. Fertil Steril 1996; 65: Key Words: Infertility, tubal patency, color Doppler, hysterosalpingography, ultrasound Recent estimates of the incidence of infertility in Italy indicate that approximately one of five couples are infertile (unable to conceive after 1 year of unprotected intercourse) (1). The occlusion ofthe fallopian tubes is the most common cause of infertility, accounting for approximately 25% of the etiologic factors. An increasing prevalence of salpingitis and a growing number of ectopic pregnancies is causing an increased number of tubal sterility (1). Until recently, the diagnosis of tubal occlusion has been made by roentgenogram hysterosalpingography (HSG) or chromoperturbation at the time oflaparoscopy (2-5). These procedures require the use of Received December 28, 1994; revised and accepted July 19, * Department of Pathophysiology of Human Reproduction, University of Modena. t Reprint requests: Cesare Battaglia, M.D., Cattedra di Fisiopatologia della Riproduzione Umana, Universita agli Studi di Modena, Via del Pozzo 71, Modena, Italy (FAX: ). :j: Department of Obstetrics and Gynecology, University of Pi sa. radiopaque dye with possible allergic reaction and radiation (6) or general anesthesia and an operation with the risk of bowel and vessel injury (7). Evaluation of fallopian tubal patency by hysterosonosalpingography, performed using either a transabdominal or transvaginal route, recently has been proposed as an alternative method to roentgenogram HSG or laparoscopy (8-10). Color Doppler has been used to increase the diagnostic efficiency (11-13). The aim of the present study was to evaluate the results obtained in the assessment of tubal patency by color Doppler HSG in comparison with roentgenogram HSG and chromolaparoscopy. MATERIALS AND METHODS From January 1992 to September 1993, 60 infertile patients of childbearing age (22 to 39 years) entered the study. Informed consent was obtained. The study protocol was approved by the Local Ethics Re VIew. Infertility lasted 3 to 14 years. Color Doppler HSG Battaglia et a1. Color Doppler hysterosalpingography 317

r Figure 1 Flow mapping. (A), Through HIS catheter, sterile saline fills uterine cavity (cholorimetric mosaic). (B), Flow through uterotubal junction (arrow).

The late proliferative phase was chosen because of better transcervical accessibility, better definition of endometrial pathologies, and contemporaneity with chro- 318 Battaglia et al.

2 r Figure 1 Flow mapping. (A), Through HIS catheter, sterile saline fills uterine cavity (cholorimetric mosaic). (B), Flow through uterotubal junction (arrow). (C), Sterile saline spills through the distal part of the tube (arrowhead). was performed in the late proliferative phase (cycle days 9 to 11), 1 to 3 days before laparoscopy. The late proliferative phase was chosen because of better transcervical accessibility, better definition of endometrial pathologies, and contemporaneity with chro- 318 Battaglia et al. Color Doppler hysterosalpingography molaparoscopy. All patients underwent roentgenogram HSG 2 to 12 months before. Presence or absence of tubal patency diagnosed by color Doppler HSG was compared with the results from roentgenogram HSG and laparoscopy in the same patients, considering the results of chromolaparoscopy as the "gold standard." Where indicated, a hysteroscopic evaluation was associated to laparoscopy. The sonographic procedures were recorded blind to the findings of other examinations. Patients with acute genital inflammation, bleeding, age < 18 years, poor general clinical conditions, and pregnancy were excluded from the study. After an explanation of the procedure, 0.25 ml atropine sulphate 1% (Atropina Farmigea; Farmigea, Pisa, Italy) plus 10 mg diazepam (Valium; Roche, Milano, Italy) were administered 1M to reduce the vasovagal effects and to obtain patient sedation. No antimicrobial treatment were required. Thirty minutes later color Doppler HSG was initiated. The examinations were performed by a single operator (C.B.) using a 6.5 (Esaote AU 590 Asynchronous; Esaote, Genova, Italy) or a 5.0 MHz (Acuson 128 XP/I0; Acuson, Milano, Italy) transvaginal transducer. Sterile saline solution was used as an echo-free contrast agent. The procedure was done with the subjects in the lithotomic position. After introduction of a speculum, the vagina and the cervix were carefully prepped with an antiseptic solution and then washed with saline. An HIS catheter (Ackrad Laboratories, SIFO, Bologna, Italy) was placed transcervically into the endometrial cavity. Two milliliters of saline was used to inflate the distal balloon of the catheter, sealing the uterine cavity and preventing vaginal fluid leakage. Speculum was removed and a B-Mode standard transvaginal ultrasonographic examination (US) was performed to image pelvic organs. Two patients with, respectively, suspected monolateral hydrosalpinx or sactosalpinx were excluded from the study. Five to 10 ml ofsterile saline then were injected into the uterine cavity to better visualize endometrium and detect uterine pathologies (polyps, submucosal fibroids) or malformations (bicornuate uterus, intrauterine septa) (14-16) (Fig. 1). This was followed by color Doppler HSG (Esaote AU 590). Through an HIS catheter, 20 to 60 ml of sterile saline were instilled intermittently. Direction and flow into and out the fallopian tubes were observed. The transvaginal probe was moved until the uterotubal junction was identified. Color mapping (Fig. 2) was used (maximizing the sensitivity to low velocity flow and minimizing the system noise) to confirm flow into the proximal portion ofthe tubes. After demonstration of forward flow through uterotubal junction for ~5 seconds, Color flow and fluid accumulation was searched in the pouch of Fertility and Sterility

Figure 2 Sterile saline instillation and peritoneal accumulation. (A), Uterine cavity dilated by a few milliliters of sterile saline.

(D), Intraperitoneal adhesion evidenced after instillation of sterile saline. Douglas.

The pain perceived by the patients was scored (1 = discomfort; 2 = tolerable; 3 = intense pain; 4 = unbearable pain) and correlated with tubal patency.

3 Figure 2 Sterile saline instillation and peritoneal accumulation. (A), Uterine cavity dilated by a few milliliters of sterile saline. (B), Distal part of the left normal tube floating in the saline (arrows), (C), Stenotic tube with (confirmed at L-CPT) fimbriae conglutination (arrow). (D), Intraperitoneal adhesion evidenced after instillation of sterile saline. Douglas. Tubal occlusion was diagnosed when no flow was observed through fallopian tubes and no fluid was seen to enter the peritoneal cavity. The duration of the examination was recorded. The pain perceived by the patients was scored (1 = discomfort; 2 = tolerable; 3 = intense pain; 4 = unbearable pain) and correlated with tubal patency. Statistical analysis of the results was performed using X 2 or Student's t-test where indicated. Statistical significance was defined as P < Data are presented as mean::!: SD unless otherwise indicated. unbearable pain, the procedure was suspended in one patient (1.7%). Cervix uteri was not held by tenaculum, and cervical dilatation was not required. RESULTS Fifty-eight patients underwent color Doppler HSG. Besides five cases of intramural and two cases of subserosal fibroids evidenced with basal US, the preliminary examination with saline of uterine cavity showed two small submucosal fibroids and one endometrial polyp. In one case the contemporary presence of a small submucosal fibroid plus endometrial polyp was observed (Fig. 3). The intracavitary findings were confirmed by hysteroscopy. Because Figure 3 Examination of uterine cavity after the injection of a few milliliters of sterile saline. At level of corpus uteri, the intracavitary examination shows the contemporary presence of submucosal fibroid and endometrial polyp; M, submucosal fibroid; P, endometrial polyp. Battaglia et al. Color Doppler hysterosalpingography 319

Color Doppler HSG was performed completely in 57 patients. The results evidenced bilateral tubal patency in 38 cases (66.5%), unilateral occlusion in 10 cases (17.

4 Color Doppler HSG was performed completely in 57 patients. The results evidenced bilateral tubal patency in 38 cases (66.5%), unilateral occlusion in 10 cases (17.5%), and bilateral occlusion in the remaining 9 cases (16%). In the last 20 cases, when a tubal spasm was suspected, the examination was repeated 3 to 5 minutes later. Where monolateral or bilateral tubal patency was diagnosed, the distal part of the tubes was evidenced in 18 (38%) cases (Fig. 1) and, in 2 cases, an intraperitoneal adhesion was diagnosed (Fig. 1). The pain score evidenced discomfort in 27 patients (47%), tolerable pain in 18 cases (32%), and intense pain in 12 cases (21%). However, most of the patients claimed that they had less discomfort and pain than with roentgenogram HSG. The pain score of 3 (intense pain) was associated in eight cases (67%) with bilateral tubal occlusion. The data obtained were compared with those of roentgenogram HSG and chromolaparoscopy (Table 1). When color Doppler HSG and roentgenogram HSG were compared with laparoscopy, no significant differences were observed, being the "simple concordance rate" (concordance = number where diagnosis agrees/total number X 100) 86% and 93%, respectively. Furthermore, color Doppler HSG and roentgenogram HSG presented a concordance of 93%. During the study we observed a significant progressive reduction of the saline used (from 54 ± 5 to 28 ± 4 ml; mean ± SD; P < 0.01) and ofthe time spent to perform the examination (from 25 ± 4 to 11 ± 5 minutes, P < 0.01) (Fig. 4). Contemporary, a progressive, even nonsignificant, improvement of the correspondence between color Doppler HSG and the other procedures was observed (Fig. 4). In the course of the transvaginal color Doppler HSG, no serious side effects were observed during and after the procedures. Six months after color Doppler HSG and chromolaparoscopy, four pregnancies (7%) were registered. DISCUSSION Sexually transmitted infections are responsible for most tubal damage associated with infertility. Evaluation of tubal patency by hysterosalpingosonography, performed using either sterile saline (8, 14) or a contrast medium (9, 15), has been proposed as an alternative method to roentgenogram hysterosalpingography or laparoscopic chromopertubation. Furthermore, the use of Doppler techniques, either one dimensional (duplex) (9) or two dimensional (color mapping) (11-13), has been used to increase the diagnostic efficiency. The present study confirms that transvaginal color Doppler HSG is a feasible diagnostic procedure to assess the status of fallopian tubes with a high degree of accuracy. When findings obtained from color Doppler HSG and traditional roentgenogram HSG were compared with the gold standard of chromolaparoscopy, no significant differences were observed with the concordance being 86% and 93%, respectively. Furthermore, color Doppler HSG showed an acceptable sensitivity (58%) and a good specificity (83%). However, the above data possibly may be misleading because, by dropping out two patients with tubal dilatation, we applied the statistical tests to a selected rather than a general population. The women were excluded from the study to obtain a basal standard condition in all the patients and to avoid sonographer's prejudices. Implementing the US basal approach, in cases of dilated tubes (hydrosalpinx, sactosalpinx) it is possible to reduce the false-positive color Doppler findings of tubal patency. This may be due to the turbulence of saline injected in the dilated salpinx. The use of saline as echo-free contrast agent allows, in the first step of color Doppler HSG, to visualize the endometrial contour and to diagnose correctly the endocavitary pathologies (16-20). Furthermore, real-time ul- Table 1 Comparison Between Color Doppler HSG* and Roentgenogram HSGt Laparoscopy in the Detection of Tubal Patency Single finding Concordance concordance between Color Doppler HSG (A) Roentgenogram HSG (B) L-CPT (C) procedures:j: AandC B andc Bilateral patency Monolateral occlusion 10 7 Right tube 7 6 Left tube 3 1 Bilateral occlusion 9 8 * Color Doppler HSG: sensitivity = 58%, specificity = 83%, positive predictive value = 58%, negative predictive value = 67%. t Roentgenogram HSG: sensitivity = 73%, specificity = 91%, positive predictive value = 73%, negative predictive value = 74%. 320 Battaglia et al. Color Doppler hysterosalpingography % % % 46 AandC= Band C = :j: Concordance = number where diagnosis agrees/total number X 100. A and C = /57 x 100; Band C = / 57 X 100. Fertility and Sterility

A B min 0-20 20-30 30-40 > 40 Patients > 40 Patients Figure 4 Color Doppler HSG. Analysis of progressive improvements. (A), Saline volume and time spent progressively and significantly decreased.

5 A B min > 40 Patients > 40 Patients Figure 4 Color Doppler HSG. Analysis of progressive improvements. (A), Saline volume and time spent progressively and significantly decreased., ml; ~, minutes (B), Color Doppler HSG concordance with roentgenogram HSG and L-CPT, even not in a significant manner, progressively improved., roentgenogram; ~, L-CPT. **P < trasonography giving a dynamic representation of pelvic anatomy add many useful information for infertility diagnosis. Similar results are not achievable with roentgenogram HSG. In the present study, the intracavitary pathologies detected by US were confirmed by hysteroscopy. This further confirms the previous reported correspondence between hydrotubation and hysteroscopy (20, 21). In our study, major discrepancies between the procedures' findings involved a diagnosis of unilateral tubal occlusion. We speculated that cornual spasm may be evocated more easily by using sterile saline because the achievement of a rapid increase of intraluminal pressure. Probably, as recently suggested, the repetition of the procedure a few minutes later may contribute to improve the test accuracy (12,13). Furthermore, slower insufflation rate, smaller saline volumes, and the use of dense echocontrast agents may improve the results and reduce the risk oftubal spasm. The reliability of color Doppler HSG probably depends also on the ultrasonographer's skill and experience. In the studied population we observed a significant progressive reduction of saline used and time spent for the execution of the procedure. The above improvements were associated to a contemporary, even if not significant, increase of color Doppler HSG and laparoscopy findings agreement. In our opinion, this limits the application of color Doppler HSG to infertility centers with good echographic experience. In the studied patients there was no need for roentgenogram HSG sets such as Rubin cannula, cervix uteri was not held by tenaculum, and cervical dilatation was not required. Furthermore, of the 45 patients who referred discomfort or tolerable pain, most claimed that it was less than with roentgenogram HSG. Moreover, in the patients who experienced intense pain, it was often (67% of the cases) associated with bilateral tubal occlusion, suggesting that in these patients the higher intrauterine pressure may evoke more pain. No serious side effects were observed during and after the procedures, and four spontaneous pregnancies were registered. Transvaginal color Doppler HSG was performed with isotonic, sterile saline and without general anesthesia; the results indicate that it is quite easy to perform, safe, noninvasive, short lasting, there is no exposure to radiation, and probably cost effective. In contrast, as stated by some researchers, roentgenogram HSG has a number of potential risks and problems in studying the upper genital tract (5-7). The radiologic examination may induce an anaphylactic reaction in sensitized patients and requires radiologic facilities and gynecological-radiological staff. Furthermore, the information is not in real time and is limited to internal Mullerian duct anatomy. In conclusion, color Doppler HSG was as good as roentgenogram HSG in evaluating tubal patency and was potentially safer (idiosyncrasy to the contrast agent cannot be expected). Moreover, color Doppler HSG could be performed on an ambulatory basis in infertility centers with good ultrasonographic experience. However, more extensive studies are necessary before adding this promising method to roentgenogram HSG and chromolaparoscopy in the screening of tubal patency in infertile women. REFERENCES 1. Spagnuolo A. II registro nazionale sulla procreazione medicoassistita dell'istituto Superiore di Sanita. In: Mazzilli F, editor. Nuovi orizzonti in tema di infertilita umana. Rome: CIC Edizioni Internazionali, 1993: Swolin K, Rosencrantz M. Laparoscopy vs. hysterosalpingography in sterility investigations. A comparative study. Fertil Steril 1972;23: Maathuis JB, Horbach JGM, van Hall EV. A comparison of the results of hysterosalpingography and laparoscopy in the diagnosis of fallopian tube dysfunction. Fertil Steril 1972; 23: Servy EJ, Tzingounis VA. Tubal patency: hysterosalpin- Battaglia et ai_ Color Doppler hysterosalpingography 321

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John R. Randolph, Jr., M.D.t Yu Kang Ying, M.D.:j: Donald B. Maier, M.D. Cecilia L. Schmidt, M.D. Daniel H. Riddick, M.D., Ph.D.1I

John R. Randolph, Jr., M.D.t Yu Kang Ying, M.D.:j: Donald B. Maier, M.D. Cecilia L. Schmidt, M.D. Daniel H. Riddick, M.D., Ph.D.1I FERTILITY AND STERILITY Copyright 1986 The American Fertility Society Vol. 46. No.5. November 1986 Prinred in U.s A. Comparison of real-time ultrasonography, hysterosalpingography, and laparoscopy/hysteroscopy