Microsurgery and in-vitro fertilization and embryo transfer for infertility resultmg from pathological proximal tubal blockage

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1 Human Reproduction vol 11 no 12 pp , 1996 Microsurgery and in-vitro fertilization and embryo transfer for infertility resultmg from pathological proximal tubal blockage T.Tomaievic' 1, M.RibiC-Pucelj, A.Omahen and B.Colja Department of Obstetrics and Gynecology, University Medical Centre Ljubljana, Slajmerjeva 3, 1000 Ljubljana, Slovenia 'To whom correspondence should be addressed The aim of this study was to evaluate the prognosis for the patients after the treatment of infertility resulting from proximal tubal blockage using microsurgical tubocornual anastomosis and in-vitro fertilization (TVT) and embryo transfer complementarity. A total of 59 microsurgical operations ( ) for infertility resulting from pathological proximal tubal lesions were analysed. The cumulative live birth rate was 52% for tubocornual anastomosis, 58% for bilateral operations and 28% for two-site operations. In all, 35 singleton babies were born. Of the 32 operated patients who did not deliver within 2 years of surgery, 21 were treated by 66 IVF cycles; 12 babies were born. The live birth rate was 18% per cycle and 57% per patient. Combining both treatment methods the cumulative live birth rate was improved up to 69% in the group of tubocornual anastomoses, up to 75% in the group of bilateral operations, and up to 57% in the group of twosite operations. Complementary use of microsurgery and FVF and embryo transfer improves the prognosis for selected infertile patients with pathological proximal tubal blockage. In the absence of pregnancy, IVF and embryo transfer should be commenced 1 year after surgery. Key words: embryo transfer/ivf/microsurgery/proximal tuba! blockage Introduction Microsurgical tubocornual anastomosis and in-vitro fertilization (TVF) and embryo transfer revolutionized the treatment of female infertility caused by pathological proximal tubal blockage. Until some years ago, there was no competition between the two methods: IVF and embryo transfer were applied after microsurgical failure. But with increasing its pregnancy rates, IVF and embryo transfer has become a possible first therapeutic choice (Audibert et al, 1991). The popularity of microsurgery has fallen, and the enthusiasm for new technologies has created the false impression that microsurgery has lost its role in infertility treatment (Chan and Ratnam, 1995). Since Gomel (1977) and Winston (1977) described the microsurgical technique for tubocornual anastomosis, other gynaecologists have tried to repeat their excellent results European Society for Human Reproduction and Embryology (Cohen and Angle, 1986). Instead of tubal implantation, the method became a standard surgical procedure for infertility caused by proximal tubal blockage. The indications and results of tubocornual anastomosis are not uniform and depend on the experience of the surgeon, type of microsurgical technique utilized (Winston, 1981; Siegler, 1994), pre-operative diagnosis and evaluation of any associated pelvic findings (De Cherney and Diamond, 1990). In the early 1980s, IVF and embryo transfer became a credible alternative to microsurgery (Edwards et al., 1980; Lopata et al, 1980; Jones et al., 1982), and can, in many circumstances, represent a primary approach (Gomel, 1983). The introduction of vaginal ultrasound and the simplification of follicle growth monitoring (Wikland, 1992), new stimulation regimens and the use of improved laboratory techniques and freezing programmes have made IVF and embryo transfer more successful and repeatable (Tan, 1994). Haemodynamic parameters detected by Doppler sonography provide additional aid to decisions in IVF and embryo transfer (Sterzik et al., 1989). Cumulative pregnancy rates of IVF and embryo transfer can be compared favourably with cumulative conception data in the normal population (Tan et al, 1992). For women up to the age of 34 years almost 55% can expect to become pregnant and 45% to have a live birth within five cycles of treatment (Tan et al, 1992; Pouly et al., 1995). Despite the finding that the overall conception and live birth rates showed a downwards trend as the treatment cycle number increased (Tan et al, 1992), the majority of infertile women would resolve their problem by repeating IVF and embryo transfer trials (Tomazevic et al., 1994). Besides the improvement in IVF and embryo transfer, the introduction of new proximal tubal catheterization techniques (Gleicher et al, 1994; Woolcott et al, 1995) and new laparoscopic techniques for tubotubal anastomosis (Dubuisson and Swolin, 1995) may render microsurgical tubocornual anastomosis obsolete in the future. We still regard microsurgery and IVF and embryo transfer as two complementary techniques for the treatment of infertility caused by pathological tubal lesions (Wiedemann and Hepp, 1989, Tomazevid and Ribid-Pucelj, 1991). According to satisfactory results from surgical treatment (Tomazevi and Andjelic, 1986), microsurgical tubocornual anastomosis remains a standard procedure for treating selected patients with pathological proximal tubal blockage at the Ljubljana University Women's Hospital (Ljubljana, Slovenia). IVF and embryo transfer is indicated in patients with inoperable lesions, in those who fail to deliver within 2 years of surgery and in those with repeated ectopic pregnancies. The aim of this study was to establish whether the treatment 2613

2 T.Tomaievifc et al strategy complementing microsurgery and IVF and embryo transfer improves the prognosis for selected patients with infertility resulting from pathological proximal tubal blockage. Materials and methods Microsurgery Long term infertility caused by pathological proximal tubal blockage was the indication for microsurgical operation. From 1986 to 1992, microsurgical tubocomual anastomosis was performed in 61 women with long-term infertility resulting from proximal tubal blockage. The pre-operative analysis of these cases included a semen analysis, a postcoital test, a basal body temperature chart, prolactin concentration measurement, an endometrial biopsy, a hysterosalpingography, a hysteroscopy and a laparoscopy Polycystic ovarian syndrome and other endocrine abnormalities were excluded. Gonadotrophin concentrations were analysed as appropriate. Male infertility was excluded, with 20X10 6 spermatozoa/ml with 40% motility and 60% normal morphology being considered to be normal. Diagnostic hysterosalpingographies were performed by gynaecologists. Laparoscopies were performed to ensure the true presence of an organic proximal lesion and to evaluate the condition of the distal tube. To avoid false-positive results, the hysterosalpingography and laparoscopy were planned in the proliferative phase of the menstrual cycle. Higher pressures were used to overcome any resistance during the chromotubation. Surgery was planned for the first half of the menstrual cycle To avoid any unnecessary operations, the last chromotubation was performed just prior to the incision of the tubal comua. The resected segments of the Fallopian tube were subjected to a pathological examination The presence of an active inflammatory process, genital tuberculosis, massive third-degree adhesions, multisite lesions and age >38 years were the contraindications for operative therapy. Mild and moderate distal tubal lesions were not considered to be absolute contraindications. Severe distal lesions, including thick-walled hydrosalpinges, distal tubal fibrosis, mucosal atrophy and follicular salpingitis, as well as multisite lesions, were considered to be inoperable, and therefore IVF and embryo transfer was proposed for these patients. A small Phannenstiel (Joel Cohen's) incision with a short cutaneous incision, transversal incision of the fascia and longitudinal peritoneal incision were practised. Magnifying glasses were only used for magnification during removal of the pathologically altered interstitial and isthmic parts of the tube. In most cases the obstruction was present in the intramural segment and extended into the isthmic segment of the Fallopian tube. Radicality of discoid interstitial tubal excision was tested by chromotubation. Patency of the isthmic part of the tube was tested by cannulation. Radicality of isthmic tubal resection was checked by magnification and palpation. The operative microscope was used for magnification during microsurgical anastomosis Anastomosis was performed over a nylon splint with four 7-0 Dexon or Vicnl sutures. A nylon splint was introduced through the tubal infundibulum to facilitate the exact, sometimes difficult, approximation of the tubal ends. According to our previous results and contrary to the generally accepted procedure, the splint was optionally left in situ for 5 days. General microsurgical principles were applied throughout' gentle tissue handling, prevention of desiccation, exact haemostasis, precise approximation and precise peritonealization without traction with the use of precise instruments, fine suture material and precise application of cautery or CO2 lasers. Dextran (70%) in normal saline (500 ml) was introduced into the pouch of Douglas. Dexamethasone in decreasing doses (starting with 16 mg on the day of the operation) 2614 plus anhbiotics (200 mg/day deoxycycline) were used during the first postoperative week to prevent adhesions. Hysterosalpingography was indicated if pregnancy did not occur by the end of first postoperative year. In cases with an unclear prognosis, a second-look laparoscopy was performed. If postoperative findings were unsatisfactory or if, despite good postoperative findings, there was no pregnancy within 2 years of surgery, IVF and embryo transfer was proposed for these patients. In-vitro fertilization and embryo transfer A total of 66 IVF cycles were performed in 21 of the 32 patients who failed to deliver within 2 years of surgery. Three IVF cycles per year were allowed, with a rest time of 4 months between each. The IVF and embryo transfer procedures applied have been described previously (Tomaievic et al, 1990, 1994). Two stimulation protocols were used: gonadotrophins alone [human menopausal gonadotrophin (HMGHiuman chorionic gonadotrophin (HCG)] in 50 cycles, and gonadotrophin-releasing hormone analogues (GnRHa) and gonadotrophins (GnRHa-HMG-HCG) in 16 IVF and embryo transfer cycles. A maximum of three embryos were transferred per patient. Evaluation of data In 1995 a questionnaire was sent to all operated patients. The results were evaluated retrospectively. Of the 61 women, two (3%) were lost to follow-up' they did not respond to the questionnaire, and their follow-up data could not be found in our IVF or outpatient registry. They were therefore excluded from the analysis. In accordance with the Madrid conference classification (Cognat, 1982), the remaining 59 pauents were classified into three groups. The first group included 26 patients with pure proximal tubal damage where only tubocomual anastomosis was performed bilateral or unilateral for the single remaining tube. The second group included 12 pauents with bilateral operations where tubocomual anastomosis was performed on one side and fimbrioplasty on the other. The third group included 21 patients with two-site operations where proximal tuba] anastomosis and distal fimbnoplasty were performed on the same tube bilateral or unilateral, if there was a single remaining tube. The live birth, abortion and ectopic pregnancy rates were evaluated. Data were collected and analysed using the Lotus 123 program. Results Microsurgery Patient pregnancy rates The mean age of the 59 pauents receiving tubocomual anastomosis was 29.6 ± 3.8 years (ranged 22-38): 34 patients with primary and 25 with secondary infertility. There were eight patients with previous deliveries, 12 patients with previous abortions and two patients with previous ectopic pregnancies. The patients were divided into three groups according to the three types of operation performed: pure tubocomual anastomosis (26 patients), bilateral operation (12 patients) and two-site operation (21 patients). Table I shows the proportion of patients in each group who experienced live births, spontaneous abortions or ectopic pregnancies following their operation. There were 54 pregnancies in 39 of the 59 patients (66%). These included 35 (65%) deliveries, six (11%) spontaneous abortions, two (4%) artificial abortions and 11 (20%) ectopic pregnancies. In all, 31 women (53%) had intrauterine pregnancies and seven (12%) had only ectopic pregnancies. Live deliveries were experienced by 27 patients (46%):

3 Microsurgery and IVF and embryo transfer for proximal tubal blockage Table I. Live births, spontaneous abortions and ectopic pregnancies following different types of operation for proximal tubal blockage in 59 patients ( ) Type of operation Tubocornual anastomosis Bilateral operation Two-site operation All operations patients Total Live births 14 (54%) 7 (58%) 6 (28%) 27 (46%) Values in parentheses arc percentages Patients with no live births b PaDents with ectopic pregnancies only Clinical abortions* 3 (12%) 1(8%) 0(0%) 4(7%) Ectopic pregnancies' 5 3(12%) 1 (8%) 3 (14%) 7 (12%) eight of them had two deliveries. In all, 17 patients (63%) had deliveries in the first year, six (22%) in the second year, three (11%) in the third year, and one (4%) in the fourth year after surgery. Three patients who received surgery were aged >35 years; all three conceived and delivered. Pathology Pathohistological examinations of the resected lsthmo-interstitial part of the tubes revealed different forms of inflammatory or postinflammatory changes, fibrosis and obliteration m i l patients, chronic salpingitis in 24 patients, salpingitis isthmica nodosa (diverticula accompanied by nodular hyperplasia of the surrounding muscularis) in 15 cases and endosalpingiosis (tubal epithelium in abnormal locations) in six cases. In one case no observable changes were found on histological examination. In two instances there were no data concerning the pathohistology. According to the pathological findings, there were six live births (54%) in patients with obliterative fibrosis, 12 live births (50%) in patients with chronic inflammation and nine live births (43%) in patients with myoepithelial lesions (endosalpingiosis and salpingitis isthmica nodosa). IVF and embryo transfer Of the 32 patients who did have a live delivery after surgery, 22 (69%) entered the Ljubljana IVF and embryo transfer programme. The mean ± SD time between surgery and the first IVF and embryo transfer cycle was 3.5 ± 1.2 years (range 2-6 years). The minimal delay was two, and the maximal delay was six years after surgery. In all, 15 (30%) pregnancies resulted from 50 HMG-HCG-stimulated cycles (eight live births, four abortions and three ectopic pregnancies). Five (31%) pregnancies resulted from 16 GnRHa-HMG-HCGstimulated cycles (four live births and one abortion). Cumulatively, 66 IVF and embryo transfer cycles gave rise to 20 pregnancies (12 live births, five abortions and three ectopic pregnancies). The pregnancy rate per cycle was 30%, the abortion rate per cycle was 8%, and the ectopic pregnancy rate was 5%. The live birth rate was 18% per cycle, and 57% per patient who entered the IVF programme Microsurgery and FVF and embryo transfer The cumulative live birth rates following 59 operations and 66 IVF and embryo transfer cycles are presented in Tables II and HI analysed in terms of the type of surgery and the type of infertility. Discussion These results raise some points for discussion. First, is the treatment strategy using microsurgery and IVF and embryo transfer as complementary techniques still appropriate? It is a prevailing idea that microsurgery has lost its favour, giving place to IVF and embryo transfer and laparoscopic surgery. However, evidence suggests that microsurgery certainly has its role in the management of tubal infertility (Chan and Ratnam, 1995; Day a, 1995) The advantage of microsurgery is shown in this study by the high intrautenne pregnancy rate (66%) following normal sexual intercourse, with a live birth rate of 55% in selected patients (first two groups). If another pregnancy is desired, there is no need for further treatment. In all, 25% of our patients had two deliveries. Combining 59 operations with 66 IVF and embryo transfer cycles, i.e. two cycles per failed operation, the cumulative live birth rate following surgical treatment in all operated groups was improved by up to 66%. If only strict indications were considered, the result would be 71% with 38 operations and 34 IVF and embryo transfer cycles in patients with pure tubocomual anastomosis and with bilateral operations. This is the real, not a theoretical, live birth rate. Thus, the strategy appears to be correct Second, could the selection of patients for microsurgery be improved? The disadvantage of surgical treatment is an increase in ectopic pregnancies (TomazeviC and Ribic-Pucelj, 1992). These occurred in 20% of all postoperative pregnancies, and in 12% of patients represented the only pregnancy. Some authors have reported better intrautenne and much lower ectopic pregnancy rates (Tran, 1995). Unrecognized distal tubal lesions may lead to absence of pregnancy or to ectopic pregnancy (Dubuisson et al., 1995). In agreement with these authors, we believe that by respecting the strict selection criteria one can avoid unnecessary operations (Devroey and Camus, 1995); however, we must admit that the contraindications for microsurgery were not always respected in our series of patients. Historically there has been a reluctance to operate on oviducts that have a combined two-site pathology at the proximal cornual and distal fimbrial ends (McComb, 1995). However, it is quite rare to find isolated lesions In cases of proximal tubal damage associated with mild and moderate distal lesions it is sometimes difficult to avoid a decision to operate. Hence, 21 two-site operations in selected patients resulted in a 28% live birth rate and a 14% ectopic pregnancy rate. With better pre-operative work-up, using falloposcopy or salpingoscopy (Devroey and Camus, 1995) to evaluate tubal mucosa, the results might be improved. Tubal catheterization was not used in the pre-operative work-up in our series of patients. With organic lesions and large resected segments of the tube (Tran, 1995) it would be difficult to avoid surgery by means of tubal catheterization. However, the cumulative knowledge suggests that transcervical tubal catheterization will be indicated for the treatment of proximal obstructions (Dubuisson et al., 1995). 2615

4 T.Tomaievli et al Table IL Cumulative results of 59 operations and 66 m-vitro fertilization (IVF) and embryo transfer (ET) cycles for infertility caused by proximal rubal blockage in three groups of patients Type of operation operations IVF cycles live births (operation + IVF/ET)* Combined live birth rate per operation (%) b Tubocomual anastomosis Bilateral operation Two-site operation All operations Live births after surgery + live births after IVF; only one live birth after surgery or IVF was considered. ''Percentage of live births after combined treatment. Table in. Cumulative results proximal tubal blockage of 59 operations and 66 m-vitro fertilization and embryo transfer cycles for primary and secondary infertility caused by Type of infertility operations cycles IVF live births (operation + IVF/ET)* Combined live birth rate per operation (%) b Primary Secondary Live births after surgery + live births after IVF, only one live birth after surgery or IVF was considered. ''Percentage of live births after combined treatment Third, what could be done to enable use of IVF and embryo transfer as a complementary technique? More IVF cycles could have been performed in our group of patients if the patients had entered the IVF programme earlier. The average waiting time to enter the programme was 3.5 years. Much uncertainty after surgery could be avoided if IVF and embryo transfer was proposed after a waiting period of 1 year. This seems to be reasonable because 65% of pregnancies occurred within 1 year, and only 20% within the second year after surgery. Some 11 patients who failed to conceive after surgery did not enter the IVF programme. If IVF and embryo transfer was recommended at an earlier time point (Audibert et al, 1991), then more IVF cycles could be performed with better cumulative results. All patients who failed to conceive should be encouraged to enter the IVF programme. Fourth, can microsurgery and IVF and embryo transfer performed by the same staff improve the prognosis for patients? With 59 operations, among those 21 two-site operations, and with 66 IVF and embryo transfer cycles, we were able to achieve a 65% live birth rate. According to Tan et al. (1992), five IVF and embryo transfer cycles per patient are necessary to achieve a 45% live birth rate. Thus in our series (twosite operations included), surgical treatment alone equals a possibility of five IVF cycles per patient. With expertise in both methods competition between the two methods could be minimized; better cumulative results can be achieved within a shorter time period with a minimal number of operations and IVF cycles. This seems to be important from the standpoints of success and economy. According to the cost benefit, it has become obvious that surgery and IVF cannot be compared directly (Devroey, 1995), because not only are no prospective randomized studies available, but in different countries different costings and systems of reimbursement are used (Devroey, 1995). In Slovenia, patients can receive two IVF and embryo transfer 2616 cycles for the cost of one tubal operation (Tomazevic and Ribic-Pucelj, 1991). It is possible that in the future laparoscopic tubal anastomosis will have indications for the treatment of proximal occlusion (Dubuisson et al., 1995). At present, the results cannot approximate the results of laparotomy, and microsurgical tubal anastomosis still remains the standard surgical method (Gomel and Wang, 1994). IVF and embryo transfer is primarily indicated in patients with severe tubal lesions, failed surgery and repeated ectopic pregnancies. It may be concluded that the complementary use of microsurgery and FVF and embryo transfer improves the prognosis for selected infertile patients with pathological proximal tubal blockage. In the absence of pregnancy, IVF and embryo transfer should be started 1 year after surgery. References Audibert, F, Hedon, B, Amal, F, Humeau, C. et al (1991) Therapeutic strategies in tubal infertility with distal pathology Hum. Reprod, 6, Chan, C.L K. and Rarnam, S.S (1995) Is there any progress in microsurgery. Ref. GynecoL Obstet., 3 (Special Issue), 20 Cognat, M. (1982) Classification of operations for tubopentoneal infertility Acta Eur. FertiL, 13, Cohen, M.B. and Angle, J.F (1986) Tubal anastomosis. In Siegler, A.M. (ed.), 77K Fallopian Tube: Basic Studies and Clinical Contributions Future Publishing Company, Mount Kisco, New York, NY, USA, pp Daya, S. (1995) Comparison of in vitro fertilization versus conventional treatment for tubal infertility. Ref. GynecoL ObsleL, 3 (Special Issue), De Cherney, A.H. and Diamond, M P. (1990) Fallopian tube reconstruction. uterotubal anastomosis. In Stangel, JJ. (ed.), Infertility Surgery. A Multimethod Approach to Female Reproductive Surgery. Appleton & Lange, New York, NY, USA, pp Devroey, P. (1995) IVF and tubal infertility Ref. GynecoL Obstet., 3 (Special Issue), 241. Devroey, P. and Camus, M. (1995) Diagnosis and treatment of proximal and distal tubal obstruction. Ref. GynecoL Obstet., 3 (Special Issue),

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