Comparative trial of tubal insufflation, hysterosalpingography, and laparoscopy with dye hydrotubation for assessment of tubal patency*

Transcription

1 FERTILITY AND STERILITY Copyright c 1986 The American Fertility Society Printed in U.SA. Comparative trial of tubal insufflation, hysterosalpingography, and laparoscopy with dye hydrotubation for assessment of tubal patency* World Health Organization Task Foreet on the Diagnosis and Treatment of Infertility, Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, Geneva, Switzerland A World Health Organization-sponsored multicentered trial comparing the efficacy of gaseous tubal insufflation with hysterosalpingography (HSG) and/or laparoscopy plus dye hydrotubation in the assessment of tubal patency was undertaken. Three hundred ninety-three women in eight centers were involved (365 insufflations, 289 HSG, 189 laparoscopy). Patency was proven. positive in 56% of insufflation, 45% of salpingography, and 52% of laparoscopy cases. Laparoscopy showed some women to have fibroids and a number of others to have ovarian abnormalities, endometriosis, pelvic adhesions, and/or congenital uterine malformation. Comparison of insufflation and HSG showed a false-positive rate of 42% and false-negative rate 24% in 363 cases. The false-positive rate of insufflation versus laparoscopy was 35% and the falsenegative rate 38% of 180 cases. Only 55% of 125 women undergoing both HSG and laparoscopy had similar findings. The results suggest that gaseous tubal insufflation should not be employed as a method of investigating tubal patency. Diagnostic reliability of HSG is poor, but it is useful as a primary screening procedure, particularly when complimented with laparoscopy plus dye hydrotubation, which is the optimum method not only for assessing tubal patency but for discovering other hitherto unsuspected disease. Fertil Steril46:1101, 1986 Received June 24, 1985; revised and accepted August 25, *Supported by the Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, Geneva, Switzerland. tthe following investigators and centers participated in the conduct and analysis of this study: Anek Aribarg, F.R.C.O.G., Chulalongkorn Hospital Medical School, Bangkok, Thailand; Chongruk Nipavong, M.D., Siriraj Hospital, Mahidol University, Bangkok, Thailand; Robert Harrison, F.R.C.O.G., St. James' Hospital, Dublin, Ireland; Lidija Andolsek-Jeras, M.D., Ginekoloska Klinika, Ljubljana, Yugoslavia; David Watcha, M.R.C.O.G., School of Medicine, University of Zambia, Lusaka, Zambia; Pier Crosignani, M.D., Universita Degli Studi di Milano, Milan, Italy; Tanya Pshenichnikova, M.D., All-Union Research Centre for Maternal and Child Care, Moscow, USSR; Yoon Chang, M.D., Institute of Reproductive Medicine and Population, Seoul National University, Seoul, Republic of Korea; Peng C. Wong, M.R.C.O.G., Kandang Kerbau Hospital for Women, Singapore; Patrick J. Rowe, F.R.C.O.G., Elizabeth M. Belsey, M.Sc., Timothy M. M. Farley, Ph.D., WHO Special Programme of Research, Development and Research Training.in Human Reproduction, Geneva, Switzerland. treprint requests: Task Force on the Diagnosis and Treatment of Infertility, Attention: Dr. Patrick J. Rowe, Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, 1211 Geneva 27, Switzerland. World Health Organization Fallopian tube patency 1101

2 Tubal disease is reported to account either in total or in part for infertility in 25% to 50% of investigated couples. 1, 2 Gaseous tubal insufflation,3 hysterosalpingography (HSG),4 and laparoscopy with dye hydrotubation 5 are diagnostic procedures for the assessment of tubal patency in current common use. Each option has certain advantages, disadvantages, and limitations. Criticism is particularly leveled at gaseous tubal insufflation, but this method is simple and inexpensive and is still employed at some centers, particularly in the developing countries, as a preliminary or screening procedure. Consequently, as part of the World Health Organization's (WHO) Special Programme of Research, Development and Research Training in Human Reproduction, a multicentered trial comparing the efficacy of gaseous tubal insufflation with either HSG and/or laparoscopy with dye hydrotubation in the assessment of tubal patency was carried out under common protocol. The results form the basis of this article. PATIENTS MATERIALS AND METHODS All subjects were selected from couples who were being investigated according to the WHO standard protocol for investigation and diagnosis of the infertile couple. Each had a history of either primary or secondary infertility of 1 or more year's duration. A total of 393 women in eight centers (Bangkok [2], Ljubljana, Lusaka, Milan, Moscow, Seoul, and Singapore) underwent one or more of the procedures within a 3-month period. Tubal insufflation was performed in 365 cases, HSG in 289, and laparoscopy with dye hydrotubation in 189. In 83% of women, tubal patency was assessed by tubal insufflation followed by HSG or laparoscopy or both, but 61 women (16%) had only one investigation and in another 7 (2%) HSG and laparoscopy were performed without tubal insufflation. CLINICAL TECHNIQUES Tubal insufflation with the use of CO2 was carried out during the first one-half of the menstrual cycle under aseptic conditions without premedication with the use of the relevant apparatus. 6 Patency was considered proven when the kymographic recording showed a rise in pressure of approximately 80 to 120 mm Hg, the pressure remaining or fluctuating at this level or lower. Also considered significant was shoulder-tip pain and the characteristic bubbling sound made by gas passing through the fimbrial end of the tube noted at auscultation above the inguinal ligament during the procedure. The test was considered negative when a steep pressure gradient to 200 mm Hg without kymographic oscillations was noted in conjunction with negative abdominal auscultation. When this occurred the insufflation procedure was repeated up to three times to verify the diagnosis. Of the 365 women, 135 had only one insufflation procedure, 76 had two, and 154 had three. HSG was carried out under fluoroscopic screening with the aid of an image intensifier a few days after cessation of menstruation. A water-soluble contrast medium (seven different types were used) was injected into the uterine cavity through a cervical cannula (one of ten different types reported). Spillage of contrast medium into the peritoneal cavity was taken to indicate that the tubes were patent, either unilaterally or bilaterally. In addition, in 77 of 289 women a delayed film was taken 30 minutes after the procedure for confirmation of findings. 7 Laparoscopy with dye hydrotubation was performed in a fully equipped operating room under general (126 of 189 cases) or local (36 of 189) anesthesia after premedication (161 of 189). Laparoscopic technique was standardized 5 as much as possible, taking into consideration local facilities and the ability and personal preferences of the individual investigator. Indigo carmine or methylene blue solution was used for per vaginal hydrotubation. In addition to the results of tubal patency so tested, the appearances of the fallopian tubes, uterus, ovaries, and peritoneal cavity, including disease pathology, were recorded on a standardized form. Although it was not logistically possible to standardize the time of cycle for the procedure, 69% of the patients had it performed from day 16, 20% between days 5 and 11, and 10% between days 12 and 15 of the menstrual cycle. DATA PROCESSING The data, including results of tubal patency assessment, findings of pelvic disease, complications of the three diagnostic procedures, and pregnancies occurring soon after the test, were collected prospectively and computerized for ret World Health Organization Fallopian tube patency Fertility and Sterility

3 Table 1. Comparative Differences in Tubal Patency Between Tubal Insufflation, Hysterosalpingogram, and Laparoscopy and Significance of Differences Between Centers False-positive Bilateral obstruction Unilaterallbilateral obstruction False-negative-bilateral patency False-negative/uncertain-. bilateral patency ap < bp < cp < Tubal insumation + hysterosalpingogram 38/90 69/143" 28/118 c 32/118 c Tubal insumation + laparoscopy 18/51 40/82 b 25/93 b 35/93 c Hysterosalpingogram + laparoscopy 4/ /49 rospective analysis. Data were recorded separately from each center, and the number ofinvestigations carried out varied between centers. Although intercenter analysis (Table 1) revealed some significant differences in the results regarding the diagnosis of tubal patency, the data from each center are combined to provide the necessary numbers for comparative purposes and for conclusions to be drawn. TUBAL PATENCY RESULTS Gaseous Tubal Insufflation Comparisons of the results of the three tubal insufflations show that the level of absolute agreement between any pair of tests was high, ranging from 83% between the first and third tests to 91 % between the second and third tests. If the data of the separate tubal insufflations are combined to give an overall result, using the finding obtained in the majority of tests or the finding of the only test in a single insufflation case, the overall outcome of tubal insufflation was positive patency in 56% of cases, uncertain in 6%, and negative in 38%. Gaseous Tubal Insufflation and HSG As illustrated in Figure 1, in 263 patients who underwent both procedures, insufflation was positive in 59% (Table 2), whereas when HSG was used both tubes were shown to be patent in only 45% of women, unilateral obstruction was found in 20% and bilateral obstruction was found in 34% of cases. Of the 90 women shown to have bilateral tubal obstruction on HSG, 38 had posi- tive findings on insufflation, giving a false-positive rate for insufflation of 42%. This rises to 69/143, or 48%, when the women with unilateral obstruction are also taken into account. Bilateral tubal patency was noted on HSG in 118 women. Of these, 28 (24%) had negative tubal insufflation and a total of 32 (27%) had negative or uncertain findings. Gaseous Tubal Insufflation and Laparoscopy with Dye Hydrotubation As shown in Figure 2, 180 patients underwent laparoscopy subsequent to gaseous tubal insufflation. Bilateral patency was found at laparoscopy in 93 (52%) (Table 3), unilateral obstruction in 31 (17%), and bilateral obstruction in 51 (30%). In this latter group, the false-positive rate of gaseous tubal insufflation was 18/51, or 35%, rising to 40/82 (49%) when those women with unilateral obstruction were included. Of 93 women in whom bilateral patency was demonstrated at laparos- 120 RESULT OF TUBAL INSUFFLATION IZ2J Positive r- rm:m Uncertain NUMBER 100 CJ Negative OF CASES ~ :~: / ~... :::: Figure 1 Tubal insufflation and HSG. Bilateral Unilateral Bilateral patency obstruction obstruction RESULT OF HYSTEROSALPINGOGRAPHY World Health Organization Fallopian tube patency 1103

4 Table 2. Tubal Insufflation and HSG HSG Tubal insuftlation Unilateral Bilateral Bilateral patency obstruction obstruction Not known Total n % n % n % n % n % Positive Uncertain Negative 28 23; Total copy, 25 (27%) had negative insufflation and 10 had uncertain findings, giving a total false-negative rate of 38% for insufflation. HSG and Laparoscopy with Dye Hydrotubation One hundred twenty-five women underwent both HSG and laparoscopy. As illustrated in Figure 3, laparoscopy revealed a lower rate of bilateral tubal obstruction (34%) than salpingography (43%) (Table 4). However, of the 43 women found to have bilateral obstruction on laparoscopy, only 4 (9%) had been shown to have bilateral patency on salpingography. This false-positive rate doubles to 18% when women found to have unilateral obstruction at laparoscopy are taken into account. However, bilateral patency was revealed on laparoscopy in 49 women, of whom only 55% had the same finding on HSG. The remaining 45% were shown with the use of salpingography to have unilateral or bilateral tubal obstruction. The findings on HSG were particularly unreliable for women shown with the use of laparoscopy to have unilateral obstruction. They were divided almost equally between bilateral patency (31%), unilateral patency (38%), and bilateral obstruction (31%). There were no significant differences as to the accuracy of the HSG and laparoscopy results according to whether a local or general anesthetic was used. ADDITIONAL INFORMATION GAINED WITH EACH TEST The only question that can possibly be answered by gaseous tubal insufflation is that of tubal patency. Acquired abnormalities of the uterus were found in 27 women after HSG and congenital abnormalities were found in 5. At laparoscopy, five uterine. congenital abnormalities (three different) were also found. During this procedure, fibroids were noted in 20 women and endometriosis in differing sites, the most common being the pouch of Douglas, in 23 cases. Laparos- copy also showed the most common lesion and site of tubal abnormality to be dilatation in the ampullary region (32 left and 24 right), the pouch of Douglas was obliterated in 18 of 40 cases, and tuboovarian adhesions were found in 48 cases, and 24 and 22 right and left ovaries, respectively, were fixed in position. COMPLICATIONS Thirty-one of 365 women who underwent gaseous tubal insufflation had complications. These were chiefly generalized discomfort and abdominal pain (20), pelvic infection (1), and collapse (1). Technical failure was recorded in 1 of 289 patients who underwent HSG and 5 experienced complications; again the most common was pain (3). It was not possible to visualize every organ in the pelvis through the laparoscope in some patients, but only 1 of 189 was reported a total technical failure. PREGNANCIES Twelve women became pregnant during the time of the study. Ten of these had positive tubal insufflation, one was uncertain, and one had neg- NUMBER 40 OF CASES RESULT OF HYSTEROSALPINGOGRAPHY IZ3 Positive ~ Uncertain 50 D Negative ~i P.i ~,',', ~ ~ 10 ::::: '9 OL-~~----~L-----~--- Bilateral Unilateral Bilateral patency obstruction obstruction RESUL T OF LAPAROSCOPY Figure 2 Tubal insufflation and laparoscopy World Health Organization Fallopian tube patency Fertility and Sterility

5 Table 3. Tubal Insufflation and Laparoscopy Laparoscopy Tubal insufflation Unilateral Bilateral Bilateral patency obstruction obstruction Not known Total n % n % n % n % n % Positive Uncertain Negative Total ative insufflation and also findings of bilateral obstruction at salpingogram. DISCUSSION The ideal method of tubal patency assessment should be simple, safe, accurate, and reliable. Laparoscopy is well recognized as the most informative and accurate procedure.8 Although reports are appearing of its accomplishment with local anesthesia plus neuroleptic drugs,9 this could possibly give rise to a higher incidence of technical problems. General anesthesia is usually, therefore, required, as are considerable skills that can be acquired only through training, if safety is to be maintained and a correct diagnosis made. It is not without hazard, having a complication rate of 36/1000, including a mortality of 8/ Concurrent ovarian biopsy study is, 10 apparently the most hazardous procedure. HSG yields specific information about the internal structure of the fallopian tubes and uterine cavity. 11 It may be uncomfortable to patients, and most accurate results require scanning equipment. Although tubal insufflation is simple and noninvasive, and despite improvement in apparatus design, its reliability has frequently been questioned,12 and this doubt is substantiated by the results of this multicenter trial. As a method of assessing tubal patency, gaseous tubal insufflation showed a high false-negative (24%) and a high false-positive patency rate (42%), compared with HSG. Some of this difference may be due to high false diagnostic rates at HSG, in part, no doubt, resulting from variations between participating centers. Overall, however, these figures are comparable to those of other workers, none of which approach the favorable results reported by Rubin, in Assessment of tubal patency with the use of HSG and laparoscopy agree in 57% of women. This lack of correlation is difficult to explain but may again point to the problems of multicenter studies with differing methodologies, facilities, and interpretations of findings. In terms of agreement between the two tests, the only significant difference between centers was in false-negatives on HSG (P < 0.05). These findings are similar to those of some authors15-17 and not as encouraging as those of others.2, 18, 19 Some of the differences, particularly the low rate of bilateral tubal occlusion at laparoscopy, compared with HSG, may be due to the fact that the former procedure is performed under general or local anesthesia. In addition, the laparoscopic dye solution is less viscous than the radiopaque medium used for HSG, and not all centers have the facilities for taking a delayed film, which improves diagnostic accuracy. However, although in this study the results of HSG are almost identical to those of other workers20, 21 and almost as poor as those of gaseous tubal insufflation, additional diagnostic information on congenital and acquired uterine abnormalities was obtained. This suggests that, contrary to the opinion of Frangenheim,22 HSG may have a role as the initial procedure of choice for RESULT OF TUBAL INSUFFLATION C3 Positive 100 o Uncertain NUMBER o Negative OF CASES Figure 3 HSG and laparoscopy. ~ ~. Bilat'e-'-,-al--UC-nil8teral Bilateral patency obstruction obstruction RESUL T OF LAPAROSCOPY World Health Organization Fallopian tube patency 1105

6 Table 4. HSG and Laparoscopy Laparoscopy HSG Unilateral Bilateral Bilateral patency obstruction obstruction Not known Total n % n % n % n % n % Bilateral patency Unilateral obstruction Bilateral obstruction Total assessing tubal patency. But proper precautions, careful technique, and sensible interpretation of the findings must be maintained if results are not to be misleading.ll, 23, 24 The physician must aim to complement hysterosalpingographic findings with those from laparoscopy with dye hydrotubation. As noted in many previous studies,2, 15, 21, 22 in addition to an accurate assessment of tubal patency, the presence, site, and type of pelvic adhesions and endometriosis may be revealed. In this study, 44% of women who had bilateral tubal patency shown on laparoscopy were also diagnosed as having minor disease, and 6% had major disease. The availability of such information, obtainable only with direct vision, enables the infertility physician in many cases to provide a diagnosis of cause to a couple. In addition, categorization systematic by the pathologist25 will enable a realistic assessment of two alternatives for further treatment, tubal surgery, and in vitro fertilization. These possibilities far outweigh the risks of the procedure, the need for general anesthesia, and the necessity for providing, at least in the majority of cases, a minimum of day bed care facilities. It is the conclusion of this WHO-sponsored multicenter study that gaseous tubal insufflation is grossly inaccurate and has no place in modern infertility investigation of tubal patency, even as a screening procedure. The diagnostic reliability of HSG in determining tubal patency is poor, requiring direct vision image intensification and a 30-minute delayed film for improved diagnostic accuracy. However, HSG may reveal intrauterine abnormalities. The overwhelming evidence suggests that laparoscopy plus dye hydrotubation is the optimum method not only for assessing tubal patency but for discovering other hitherto unsuspected disease of possible significance to the infertile couple. Acknowledgments. We thank Mrs. Diana Fortune and Mr. Alain Pinol for the data processing and Ms. Celia Treasure for typing the manuscript. REFERENCES 1. Arronet GH, Eduljee SY, O'Brien JR: A nine-year survey of fallopian tube dysfunction in human infertility: diagnosis and therapy. Fertil Steril 20:903, Harrison RF, Waltzman M, McGuinness E, Gill B, Kidd M: Investigation and treatment of the infertile couple in Ireland. Clin Exp Obstet Gynecol 7:145, Rubin IC: Non-operative determination of patency of fallopian tubes in sterility: intrauterine inflation with oxygen and production of a sulphrenic pneumoperitoneum. JAMA 74:1017, Pontifex G, Trichopoulos D, Karpathios S: Hysterosalpingography in the diagnosis of infertility (statistical analysis of 3437 cases). Fertil Steril 23:829, Steptoe PC: Laparoscopy in Gynaecology. London, E & S Livingstone Ltd, Rubin IC: Diagnostic and therapeutic effect of kymographic uterotubal insufflation with comparative observations with hysterosalpingography. J Obstet Gynaecol Br Emp 54:733, Sweeney WJ III: Pitfalls in present-day methods of evaluating tubal function. II. Hysterosalpingography. Fertil Steril 13:124, Corson SL: Use of the laparoscope in the infertile patient. Fertil Steril 32:359, Wbeelees CR: An inexpensive laparoscopy system for female sterilization. Am J Obstet Gynecol123:727, Royal College of Obstetricians and Gynaecologists: Gynaecological laparoscopy: report of the Working Party of the Confidential Enquiry into Gynaecological Laparoscopy. (Chairman, G. Chamberlain). Br J Obstet Gynaecol 85:401, Siegler AM: Hysterosalpingography. Fertil Steril 40:139, Jeffcoate TNA: Tubal patency test. Proceedings of the Society of the Study of Sterility. Fifth Liverpool Conference, Sobrero AJ, Silberman CJ, Post A, Ciner L: Tubal insufflation and hysterosalpingography: a comparative study in 500 infertile couples. Obstet Gynecol 18:91, Rubin IC: Comparison of carbon dioxide and opaque media in the diagnosis of tubal patency. Fertil Steril 3:179, World Health Organization Fallopian tube patency Fertility and Sterility

7 15. Maathuis JB, Horback JGM, van Hall EV: A comparison of the results of hysterosalpingography and laparoscopy in the diagnosis of fallopian tube dysfunction. Fertil Steril 23:428, Gomel V: Laparoscopic tubal surgery in infertility. Obstet Gynecol 46:47, Snowden EU, Jarrett JC II, Dawood MY: Comparison of diagnostic accuracy of laparoscopy, hysteroscopy, and hysterosalpingography in evaluation offemale infertility. Fertil Steril 41:709, Kerise M, Vandervellen R: A comparison of hysterosalpingography and laparoscopy in the investigation of infertility. Obstet Gynecol 41:684, Hutchins CJ: Laparoscopy and hysterosalpingography in the assessment of tubal patency. Obstet Gynecol 49:325, Coldtart TM: Laparoscopy in the diagnosis of tubal patency. J Obstet Gynaecol Br Commonw 77:69, Gabos P: A comparison of hysterosalpingography and endoscopy in evaluation of tubal function in infertile women. Fertil Steril 27:238, Frangenheim H: Comparative studies on the value of pertubation and hydrotubation with direct observation by means of the caelioscope. Z Geburtshilfe Gynaekol 168:189, Swolin K, Rosencrantz M: Laparoscopy vs. hysterosalpingography in sterility investigation: a comparative study. Fertil Steril 23:270, Moghissi KS, Sim GS: Correlation between hysterosalpingography and pelvic endoscopy for the evaluation of tubal factor. Fertil Steril 26:1178, Palmer R, Enault G, Schmidt D: Contraindications to tubal restorative surgery. Proposal for a dissuasive laparoscopic score. In Studies in Fertility and Sterility: Diagnosis and Management of Tubo-Uterine Factors in Infertility, Edited by RF Harrison, J Bonnar, W Thompson. Lancaster, MTP Press, 1984, p 185 World Health Organization Fallopian tube patency 1107