1 12 Metfield Croft, Harborne, Birmingham B17 0NN, 2 The Assisted Conception Unit, Birmingham Women's Hospital, Metchley Park Road, Birmingham B15 2TG and 3 School of Mathematics and Statistics, University of Birmingham, Birmingham B15 2TT, UK
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Abstract |
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Key words: infertility/proximal tubal obstruction/selective salpingography/tubal catheterization/tubal perfusion pressure
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Introduction |
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With SS, in contrast to either hysterosalpingography (HSG) or laparoscopy and dye test, individual Fallopian tubes are assessed. The opportunity therefore exists to record the tubal perfusion pressure (TPP). Limited information is available about the practical applications of TPP measurements in the management of the infertile couple. TPP measurements are thought to enhance the diagnostic capability of SS/TC in that patent Fallopian tubes with normal compliance (and therefore normal TPP) can be differentiated from patent but non-compliant Fallopian tubes (with high TPP) (Gleicher et al., 1992; Gleicher and Karande, 1996
). A significantly higher pregnancy rate can be expected in women with normal TPPs in comparison with women with elevated TPPs after controlled ovarian stimulation with either gonadotrophins or clomiphene citrate (Karande et al., 1995a
).
Tubal catheterization techniques have been successfully used not only in cases of proximally obstructed oviducts in an attempt to unblock them, but also in cases of patent Fallopian tubes with elevated TPPs, in order to lower them (Hilgers and Yeung, 1999). Whether such reductions result in improvements in conception rates remains uncertain. The aim of this study was to evaluate the effect of TC induced reductions in TPPs on subsequent fertility.
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Materials and methods |
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Using the above median and 90th percentile TPP values as cut-offs, Fallopian tubes were classified as follows: L low pressure (if TPP 300 mmHg); I intermediate pressure (if TPP >300 mmHg and
500 mmHg); and B high pressure (if TPP >500 mmHg or absent Fallopian tube). Unilateral salpingectomy had been performed in 11 cases. Each subject with complete TPP information was then placed, on the basis of the combination of TPP values from both Fallopian tubes, in one of the following six TPP categories: LL, LI, LH, II, HI and HH. The TPP categories were combined in three groups, to define the subjects' TPP status as good (categories LL and LI), mediocre (categories LH and II) or poor (categories HI and HH).
Equipment and technique used
The method used has been described elsewhere (Papaioannou et al., 2002a,b
). In brief, the Fallopotorque (Cook, Letchworth, Hertfordshire, UK) SS/TC catheter system was used. It includes a (roadrunner) guide-wire, which is 145 cm in length and 0.035 inch (0.89 mm) in diameter. Its surface is covered with a hydrophilic polymer coating, which attracts and holds liquids, thereby creating a low-friction surface. It terminates in a straight, 7-cm long tip, which tapers to 0.025 inch (0.64 mm).
The fluoroscopic unit employed was the mobile Phillips Optimus BV29 with a C-arm system (Phillips Corporation, The Netherlands). The distal end of the selective salpingography catheter was connected by polyethylene tubing to a syringe pump (KMAR-400; Cook) and by means of a three-way stopcock to a pressure sensitive transducer, which conveyed information to a computer. The pump was activated to flush the catheter with contrast medium and the encountered background resistance was displayed as a pressure curve on the computer screen while a hard copy printout could be obtained (Figure 1). The radiation dose to the patient was measured as a dose-area product (DAP) with a fitted calibrated meter (PTW, Freiburg, Germany). The DAP is a measure of the total energy imparted to the patient for the complete examination. The fluoroscopic screening time was monitored by an automatic timer on the unit control panel. The precision of the screening times was limited by the minimal 6 s increments of the timer.
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Data collection
TPP data were extracted from TPP curves stored on computer (Figure 1). The maximum TPP value after TC, minus the system background pressure for each Fallopian tube was used in the analysis. Reproductive outcome was assessed with semi-structured questionnaires sent to women along with pre-paid reply envelopes in August 2000. A second mailshot was sent to women who had not responded in January 2001. Subsequently, we telephoned those women whose responses were unclear or incomplete as well as non-responders. If the telephone numbers in the patient's case notes were inaccurate, their family doctor or the health authority was contacted to identify the patient's current phone number.
Statistical methods
Only the woman's first conception during the study period was considered. Proportional hazards survival analysis was used. Both the Cox and the parametric Weibull models were fitted. Parameter-estimates from the Weibull model are presented because of their convenient interpretation as multiplicative factors operating directly on the time to conception (Collett, 1994).
On an initial analysis, only spontaneous conceptions were counted as successes. Conceptions arising after medical intervention were considered as censored at the time of conception. Cases for whom no conception was reported were censored at the time of the mail or telephone follow-up. In a supplementary analysis the definition of success was extended to include all first conceptions except those arising from IVF or ICSI treatments. Thus, in the supplementary analysis, conceptions resulting from clomiphene citrate, in-utero insemination or ovulation induction treatments were also counted as successes. StatView version five software (SAS Institute Inc., 1998) was used for statistical analysis.
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Results |
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Of the 104 women, subsequent to TC, 29 (27.9%) could be classified in the good (group A), 25 (24%) in the mediocre (group B), while 50 women (group C) (48.1%) remained in the poor TPP status group. Groups A, B and C were not statistically different in terms of age and duration of infertility at SS/TC, type of infertility (primary/secondary), presence of male factor, endometriosis and anovulation (Table I).
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Laparoscopy had been performed in 110 (73.3%) of these patients. Endometriosis was identified in eight (7.3%) of them. After TC, these patients could be classified in the TPP groups as follows: group A one patient, group B two patients and group C five patients.
The median values for the DAP and screening time were 48 cGy cm2 (interquartile range 46.5) and 76.5 s (interquartile range 75.25) respectively.
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Discussion |
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Treatment of proximal tubal disease by guide-wire tubal catheterization is an integral part of most methods of selective salpingography, either under fluoroscopic (Thurmond and Rosch, 1990; Lang and Dunaway, 1996
) or hysteroscopic control (Novy et al., 1988
). No doubt exists about its effectiveness in achieving tubal recanalization (Gleicher et al., 1994
). However, considerable skepticism has been expressed about the probability of intrauterine implantation after successful tubal recanalization with TC.
Gleicher et al. in a series of 25 infertile women who underwent TC after unsuccessful selective salpingography, reported a single conception (an ectopic pregnancy) with follow-up periods of 517 months. This was despite a 77% successful tubal recanalization rate achieved in their series (Gleicher et al., 1994). In a similar group of seven women, Woolcott et al. reported a single conception (again an ectopic pregnancy) with mean follow-up of 17 months after recanalization by guide-wire alone (Woolcott et al., 1995
). The authors concluded that, where guide-wire alone without catheterization is performed, the prognosis with regard to pregnancy is poor and that this should not be seen as treatment of proximal tubal occlusion.
Our findings regarding tubal catheterization appear to be more optimistic. The smaller number of women, the absence of TPP measurements and the shorter follow-up in the previous studies might explain this discrepancy. Only 27.9% of our patients could be classified in group A after TC. If this percentage was similar in the previous studies, only nine of the 32 patients they included could be classified in the good prognosis group. Without knowing the TPP values after TC, it is plausible to assume that this number could have been even smaller. In our population pregnancies were reported throughout the follow-up period (range 1656 months). Again, we may assume that, had the patients in the previous studies been followed up for longer, some benefit of TC might have become evident. Therefore, the problem might not lie with TC itself but rather with the absence of an objective means of assessing the results of the treatment. We believe that measurement of TPPs can fill this gap.
The mechanism by which pregnancy rates for infertile women improve after reductions of raised TPPs achieved by tubal catheterization, might lie in the concept of proximal tubal disease (Gleicher and Karande, 1996). Proximal tubal disease is viewed as a continuum, with tubal patency and complete tubal blockage being only the extremes of a spectrum. Measurement of TPPs can uncover and probably quantify the severity of cases of partial tubal blockage. These, depending on aetiology as with complete proximal tubal blockage, can be successfully treated with tubal catheterization. The result of the intervention can be clinically assessed by measuring the magnitude of TPP reduction, which when significant, as defined in this paper, marks an improvement in prognosis.
It is important to interpret the results presented in the light of the methodology used. As our study is of cohort design, it provides evidence of a possible association, but cannot guarantee protection against bias. If our results are prospectively confirmed by a randomized trial (which we plan to undertake) then TPP measurements should become an integral part of SS/TC, as they would contribute substantially to fertility treatment decision-making. Depending on the specifics of each case, women for whom good TPPs are achieved through TC may be followed up expectantly, and ovulation induction with either clomiphene citrate, gonadotrophins or intrauterine insemination (IUI) may be considered. Women that after undergoing TC remain in the poor or mediocre TPP status groups, even though the tubes are patent, should be advised that early resort to IVF is indicated. Fallopian tubes that are judged to be normal by opacification pattern may have elevated TPPs (Gleicher et al., 1992). Therefore, normal tubal opacification patterns alone, without TPP measurements, should not necessarily be regarded as consistent with good prognosis.
The incorporation of TPP measurements in the routine performance of SS/TC appears to be justified, and the diagnostic information provided by TPPs might also support a wider role for SS/TC in the investigation and treatment of the infertile couple. The incidence of proximal tubal blockage in infertile women who present with tubal disease has been reported as 1025% (Honore et al., 1999). There is no information about the incidence of elevated TPPs in infertile women that might present without any tubal problems on simple opacification or laparoscopy and dye studies and perhaps have been labelled as unexplained cases of infertility. Some of these patients could benefit from SS with TPP estimation, followed by TC.
Despite its endorsement by respected professional bodies (American Fertility Society, 1993; Royal College of Obstetricians and Gynaecologists, 1998
) SS/TC is still only offered by a few tertiary reproductive medicine units. The reasons for this have not been documented. Concern about the technical difficulty of the procedure and the consequences of the irradiation of the ovaries of reproductive age women, may partly explain this limited usage. Our group has addressed these issues with reassuring results (Papaioannou et al., 2002a
,b
). Another possible explanation is the fact that SS/TC has been seen, so far, as a method relevant only to infertile women with proximal tubal blockage, a relatively infrequent presentation. We would think that the information presented here and in our previous work, would create interest in the technique, which, by its relative simplicity and modest equipment requirements, as well as by its potential to reduce the utilization of more expensive diagnostic and therapeutic interventions, lends itself to more widespread use.
High TPP values have been associated with the presence of tubal endometriosis (Karande et al., 1995b). In this study there was a higher proportion of laparoscopically diagnosed endometriosis patients in group C than in the other groups, although the actual numbers were small. The presence of peritoneal endometriosis does not necessarily imply the existence of tubal endometriosis and vice versa. Nevertheless, based on this fact, one could hypothesize that the presence of endometriosis in a patient is a negative prognostic factor as far as the possibility of successful TC reduction of elevated TPPs is concerned. The confidence intervals of the improvement rates noted were quite wide (Table III
). More research would be necessary to clarify the exact magnitude of the improvement in fertility prognosis achieved by TC.
The normal reference range for TPPs is still a matter of debate. Gleicher et al. felt that normal TPPs during selective salpingography were 40350 mmHg (Gleicher et al., 1992). Using a different TPP measurement set-up, and in some cases laparoscopy, Hilgers and Yeung found that, in freely patent tubes, the mean (± SD) TPP was 403 ± 46 mmHg (Hilgers and Yeung, 1999
). Both groups used fluoroscopic guidance, as was the case in our study. Different results were presented in abstract form (Kaseki et al., 1991
). During hysteroscopic selective salpingography and using Indigo Carmine instead of water-soluble radiopaque medium, they recorded systolic and diastolic TPPs (mean ± SD) of 84.8 ± 41.6 and 72.3 ± 9.6 mmHg respectively. When carbon dioxide was used the respective values were 103.1 ± 15.2 and 86.6 ± 2 mmHg (Kaseki et al., 1991
). Using a TPP measurement set-up similar to that proposed by Gleicher et al. we reached a similar conclusion.
In conclusion, this study shows a clear benefit of transcervical guide-wire tubal catheterization in pregnancy rates, where the resulting fall in TPPs allows women to be reclassified in the good TPP status group, as defined above. Therefore, SS/TC combined with TPP measurements represents an intervention, which provides not only more accurate diagnosis of tubal condition, but also offers the opportunity for effective, minimally invasive treatment.
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Notes |
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* This study was partly funded by Cook Australia, Brisbane
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References |
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Submitted on January 2, 2002; resubmitted on February 14, 2002; accepted on March 27, 2002.