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 in the evaluation of uterine abnormalities and tubal patency* 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 Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Connecticut Health Center, Farmington, Connecticut In a study to assess real-time ultrasonography (US) as an alternative to hysterosalpingography (HSG) in the evaluation of uterine abnormalities and tubal patency, 61 women underwent US immediately before hysteroscopy/laparoscopy. Saline was instilled into the uterus to provide contrast during US. The findings were compared with surgical and preoperative HSG findings. With surgical findings as the standard, US was as accurate (sensitivity 98%, specificity 100%) as HSG (sensitivity 98%, specificity 92%) in demonstrating uterine abnormalities and provided a more complete assessment of the abnormality. US was as accurate (sensitivity 100%, specificity 91%) as HSG (sensitivity 96%, specificity 94%) in demonstrating the presence of tubal patency but less accurate in establishing which tubes were patent. Thus real-time US with fluid instillation provides an accurate alternative to HSG in screening for uterine abnormalities and tubal patency. Fertil Steril46:828, 1986 The evaluation of female genital tract anatomy is an essential part of an investigation of infertility or recurrent pregnancy wastage. Tubal factors are involved in 25% to 50% of infertile couples! Received March 11, 1986; revised and accepted July 7, 1986. *Presented in part at the Forty-First Annual Meeting of The American Fertility Society, September 28 to October 2, 1985, Chicago, Illinois. treprint requests: John F. Randolph, M.D., Division ofreproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Michigan Medical Center, Ann Arbor, Michigan 48109-0010. :j:present address: Nassau County Medical Center, East Meadow, New York. Present address: University of Medicine and Dentistry of New Jersey, New Jersey Medical School, Newark, New Jersey. IIPresent address: Medical Center Hospital of Vermont, Burlington, Vermont. and uterine abnormalities are found in 15% to 27% of women with chronic fetal wastage. 2, 3 Operative evaluation with hysteroscopy and laparoscopy remains the definitive modality for identifying upper genital tract abnormalities. Hysterosalpingography (HSG) is the most widely used nonoperative method of evaluating the uterus and fallopian tubes. A hysterosalpingogram is easier, safer, and less expensive than surgery and allows other diagnostic and therapeutic measures to be implemented before surgery if no abnormalities are found on radiographic examination. However, this technique has several inherent disadvantages, including exposure to ionizing radiation, exposure to iodinated contrast material, and limitation ofthe investigation to include only the inner contour of the upper genital tract. Moreover, when compared with 828 Randolph et ai. US versus HSG for uterotubal assessment Fertility and Sterility
laparoscopy, HSG concurs only 46% to 78% of the time. 4 Ultrasonography (US) potentially offers a nonionizing alternative to HSG in the evaluation of the female genital tract. Richman et al. 5 found it to be comparable to HSG in detecting tubal patency with the use of intrauterine fluid injection. To date, no studies have been done to compare US findings with surgical findings. In our study to evaluate US in the evaluation of the female upper genital tract anatomy, 61 women had pelvic ultrasound examination immediately before hysteroscopy and/or laparoscopy was performed to investigate infertility or pregnancy wastage. Saline was instilled into the uterus during US to provide sonographic contrast. The findings were compared with those of operative evaluations and available preoperative HSGs. MATERIALS AND METHODS After induction of general anesthesia with endotracheal intubation, the patient was placed in the dorsal lithotomy position with a slight reverse Trendelenburg inclination. A Rubin's cannula was affixed to the cervix after routine preparation with povidone-iodine (Parke-Davis and Co., Sandy, UT) and the bladder was filled with 400 ml of isotonic saline via a Foley catheter (C.R. Bard, Inc., Murray Hill, NJ). After a baseline scan was done, isotonic saline was instilled in a pulsatile fashion into the uterus via the cannula, while transabdominal real-time US was performed. An average volume of 200 ml was required for a complete study. An RT 3000 realtime sector scanner (General Electric Co., Medical Systems Group, Milwaukee, WI) with a 3.5- MHz transducer was used. Following US, the bladder was drained and hysteroscopy and/or laparoscopy performed. Ultrasound and available preoperative HSG findings were compared with operative findings. Of 61 patients undergoing US, 60 had laparoscopy; of these, 53 had preoperative HSGs. Fiftyfour patients had hysteroscopy; 49 of these had preoperative HSGs. RESULTS The configuration of the uterine cavity was easily seen when the cavity was filled with saline, and expansion and decompression were routinely seen in the presence of tubal patency. Fluid was Figure 1 A longitudinal scan of a normal pelvis during pulsatile instillation of saline demonstrates (a) the Foley catheter in the distended bladder; (b) the cannula tip in the cervical canal; (c) a normal uterus; (d) accumulated cul-de-sac fluid, demonstrating at least unilateral tubal patency; (e) a distal tube silhouetted in cul-de-sac fluid; and (f) turbulence from the distal tube, demonstrating patency. noted to collect in the cul-de-sac in the presence of patency. The distal tube frequently could be seen silhouetted in accumulated cul-de-sac fluid when the volume was> 75 to 100 ml. The flow of fluid in the uterine cavity and in the cul-de-sac could be seen as turbulence, indicating patency of the associated tube (Fig. 1). Turbulence occasionally was seen lateral to the uterus in the proximal tube, indicating patency. Rarely, fluid was noted to collect only above the uterine fundus, if the cul-de-sac was obliterated by adhesions or a mass. In the presence of obstructed tubes, the uterine cavity expanded without subsequent decompression. The tubes proximal to the obstruction could Vol. 46, No.5, November 1986 Randolph et ai. US versus HSG for uterotubal assessment 829
c Figure 2 Bilateral isthmic occlusion is demonstrated by (a) a distended uterine cavity that does not decompress between saline pulses; (b) visualized isthmic tubes that do not decompress; and (c) the absence of cul-de-sac fluid. Compared with hysteroscopy in the evaluation of uterine abnormalities, US agreed in 53 of 54 patients. The single false-negative was a bicornuate uterus with a rudimentary left horn that appeared normal on ultrasound examination. Four uterine septi, two endometrial polyps, a unicornuate uterus, and a 3-cm myoma adjacent to a normal cavity all were identified correctly. No significant uterine synechiae were encountered in the patients studied. In contrast, prehysteroscopic HSGs agreed in 44 of 49 patients studied; four false-positive studies appeared to demonstrate filling defects that were not confirmed at hysteroscopy. Thus the sensitivity (98%) and specificity (100%) of US compare favorably with the sensitivity (98%) and specificity (92%) of HSG in detecting uterine abnormalities. Compared with laparoscopy in the detection of at least unilateral tubal patency, as indicated by the accumulation of fluid in the cul-de-sac, US agreed in 51 of 56 patients evaluated. No patients with obstructed tubes were noted to have accumulated fluid, whereas five patients with at least one tube patent at laparoscopy did not demonstrate cul-de-sac fluid. Of 53 patients who underwent preoperative HSG, 2 were noted falsely to be patent (sensitivity 96%) and 3 falsely to be obstructed (specificity 94%). This is similar to the values for US (sensitivity 100%, specificity 91%) in establishing the presence of tubal patency. be visualized, and no fluid collected in the cul-desac (Fig. 2). Distal tubal obstruction resulting in a hydrosalpinx could be demonstrated by the presence of a circumscribed fluid collection before saline instillation and a subsequent expansion of the collection after saline instillation. Uterine septi were well visualized when the cavities were distended with saline, and the extent of the septum could be delineated (Fig. 3). Septi were noted to be more sonodense than myometrium. Endometrial polyps could be identified and located when silhouetted in intrauterine saline (Fig. 4). The relationship of myomas to the fluid-filled endometrial cavity also could be delineated during fluid instillation, thus providing an assessment of possible distortion of the cavity by an impinging submucus myoma. Figure 3 A transverse scan of a septate uterus through the fundus demonstrates the divided cavity distended by saline and the intervening septum (arrow). Note the increased sonodensity of the septum. 830 Randolph et ai. US versus HSG for uterotubal assessment Fertility and Sterility
roscopically obstructed for a sensitivity of 98%. In contrast, of 106 tubes evaluated with preoperative HSG, 9 were thought to be obstructed when laparoscopically patent for a specificity of 92% and 4 demonstrated patency when laparoscopically obstructed for a sensitivity of 96%. Figure 4 Following distension of the uterine cavity with saline, longitudinal (upper) and transverse (lower) scans allow visualization of an endometrial polyp on the posterior wall of the cavity (arrows). Compared with laparoscopy in the localization of side-specific tubal patency, US agreed in only 76 of 112 tubes evaluated_ Of the 56 patients who had US, 9 demonstrated fluid accumulation in the cul-de-sac but no turbulence indicating the side of the patency. Because a positive or negative value could not be assigned to these 18 tubes, they were not included in the calculation of sensitivity or specificity. Sixteen of the 94 analyzed tubes did not demonstrate turbulence, despite laparoscopic evidence of patency for a specificity of83%. Only 2 of 94 tubes were thought to be patent when lapa- DISCUSSION HSG presents a number of potential problems in evaluating the upper genital tract. Exposure to ionizing radiation raises concerns of possible oncogenesis or teratogenesis. Iodinated contrast materials could produce an anaphylactic reaction in a sensitized patient. The information obtained is limited to internal Mullerian duct anatomy, requiring laparoscopy to delineate a septate from a bicornuate uterus. Disagreement between HSG and surgical evaluation may be as high as 54%,4 due at least in part to overreading of peri tubal disease on HSGs. Moreover, this te,chnique requires radiologic facilities and associated staff. US offers certain advantages over HSG. The elimination of iodinated contrast and ionizing radiation removes their associated risks. US provides a three-dimensional view of the entire pelvis, thus delineating uterine abnormalities at the time of the study. It may be performed by an experienced ultrasonographer with standard real-time equipment, an increasingly common commodity in a modern infertility practice. Thus it may provide a safer and more convenient screen of pelvic anatomy early in an evaluation, if the equipment and expertise are readily available. In this study, all patients were under general anesthesia for diagnostic laparoscopy and/or hysteroscopy to provide immediate correlation by the accepted standards; thus, patient discomfort could not be assessed and presents a significant potential drawback of the technique, especially with the large volumes of fluid needed for the localization of tubal patency. However, uterine anatomy and verification of tubal patency without localization can be ascertained with much smaller volumes of fluid. In the one previous study5 exploring this technique, "sonosalpingography" was performed immediately before conventional HSG. A minimum of 20 ml of Hyskon (Pharmacia Laboratories, Piscataway, NJ) was instilled in 35 unanesthetized patients, and no mention of discomfort was made. The presence of cul-de-sac fluid was thought to Vol. 46, No.5, November 1986 Randolph et al. US versus HSG for uterotubal assessment 831
indicate tubal patency and demonstrated a high correlation with subsequent HSGs. Uterine anatomy or subsequent surgical verification were not addressed. The results of our study confirm these findings and extend them, to show that ultrasound findings correlate well with hysteroscopic findings of uterine anatomy and laparoscopic findings of tubal patency. No infectious complications of this technique were encountered in the study. An accurate assessment of the associated infection rate and comparison to HSG will require a larger study population with no other confounding variables, such as surgery, immediately after the US. Dynamic US of the Mullerian tract with the use of a simultaneous intrauterine saline infusion, when compared with HSG: (1) provides an accurate and more complete assessment of uterine anatomy; (2) is as accurate in demonstrating the presence of tubal patency; (3) is potentially safer; and (4) is potentially more convenient and less expensive as a screening procedure. However, the technique: (5) is less accurate in establishing the location of tubal patency; (6) does not provide an accurate assessment of tubal anatomy; and (7) has not been evaluated adequately in unanesthetized patients. HSG remains the most effective method of evaluating the tubal lumen. Further evaluation of dynamic US in a larger population of unanesthetized patients will clarify its role as an alternative to HSG. Acknowledgments. We wish to extend our utmost gratitude to Audrey Bergenty for her expert preparation of the manuscript. REFERENCES 1. Jones HW Jr, Rock JA: Reparative and Constructive Surgery of the Female Generative Tract. Baltimore, Williams & Wilkins, 1983, p 10 2. Stray-Pedersen B, Stray-Pedersen S: Etiologic factors and subsequent reproductive performance in 195 couples with a prior history of habitual abortion. Am J Obstet Gynecol 148:140, 1984 3. Harger JH, Archer DF, Marchese SG, Muracca-Clemens M, Garver KL: Etiology of recurrent pregnancy losses and outcome of subsequent pregnancies. Obstet Gynecol 62: 574, 1983 4. Corson SL: Use ofthe laparoscope in the infertile patient. Fertil Steril 32:359, 1979 5. Richman TS, Viscomi GN, dechemey A, Polan ML, AIcebo LO: Fallopian tubal patency assessed by ultrasound following fluid injection. Radiology 152:507, 1984 832 Randolph et al. US versus HSG for uterotubal assessment Fertility and Sterility