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Discussion The previous demonstration of an association of abnormal expression of mannose-ligand binding receptors and poor fertilization does not necessarily prove cause and effect Benoff et al., 1993b ; . The possibility exists that when this abnormal sperm function occurs in men not taking calcium channel blockers, it may be associated with some other as yet undiscovered abnormal sperm function that is the main factor causing the reduced fertility potential of the spermatozoa. Thus, our data could be consistent with the hypothesis that calcium channel blockers can inhibit mannose-ligand receptor expression on sperm heads after capacitation but do not suppress some other cryptic factor needed for fertilization that usually accompanies this defect when not related to use of calcium channel blockers. Recently, the Cornell group presented an abstract at the 12th Annual Meeting of the ESHRE in Maastricht 1996 ; , demonstrating that four of five patients achieved a pregnancy after the male partner stopped taking calcium channel blockers Hershlag et al., 1996 ; . In none of these cases had it been demonstrated that the couples failed to fertilize while on calcium channel blockers. Three of the couples had specific treatments rendered to the wives for female factors. The fact that two of the patients were able to achieve fertilization with IVF, after being taken off the calcium channel blockers, does not have much significance in view of never having previously demonstrated failed fertilization, especially since we demonstrated that all 11 of our couples in study 1 taking calcium channel blockers had adequate fertilization. The other three couples all achieved pregnancies after the men stopped using calcium channel blockers Hershlag et al., 1996 ; , but this could also be fortuitous since our study 2 found pregnancies occurring in five of 11 45.4% ; treated couples where the male was still taking calcium channel blockers during the infertility therapy. Furthermore, there was moderate oligoasthenozoospermia rather than unexplained infertility plus advanced age of the female partner to explain why the other 55% did not conceive in our study. The possibility exists that the nifedipine used by the majority of men in the Cornell study has more of an adverse effect on sperm function than does verapamil, which was used by the majority of men in the study presented herein. For the IVF group only one of the 11 men took a 1, 4-dihydropyridine class drug similar to nifedipine and that was procardia; in contrast, seven of the 11 took verapamil in the present IVF study. Data have previously been presented suggesting that verapamil may increase sperm motility and accelerate acrosome reaction Roldan et al., 1987 ; . The one patient in our IVF study taking procardia had three cycles of IVF and the fertilization rates were 81, 50, and 75% respectively; a pregnancy was achieved. For the non-IVF group, the large majority also were treated with verapamil nine of 11 ; but both remaining patients one taking procardia and one using cxrdizem ; achieved pregnancies. Another confounding variable that could exist between the Cornell study and the study presented here is possibly different patient demography. AfroAmerican patients, for example, may be more sensitive to calcium antagonists than Caucasian 1482.
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External validity generalisability The results of randomised controlled studies may not be generalisable to all patients outside the clinical trial setting. Randomised controlled trials usually address the question of whether a treatment can work efficacy ; but may not tell us about whether the treatment will be effective when offered to the broad range of patients seen in day to day clinical practice. Randomised controlled studies tend to enrol only a small proportion of the potential population of patients with the disease of interest. Often extensive inclusion and exclusion criteria are used in order to limit sources of heterogeneity that may influence the study results Fletcher, Fletcher et al. 1988 ; . Applicability is closely related to the concepts of generalisability and external validity but it also encompasses broader issues relating to the overall impact of the therapy on individual patients Dans, Dans et al. 1998 ; . Factors that may affect the applicability of trial results to individual patients Differences in the pathophysiological basis for disease in different populations. Between population differences in the response to treatment e.g. differences in drug metabolism or immune responses ; Differences in patient compliance Differences in baseline risk for adverse events being targeted by the treatment. Presence of comorbid conditions that may alter the potential benefits and risks of treatment. Feasibility of implementing treatments in different clinical settings e.g. factors such as technical requirements for safe and effective administration of therapy, availability of trained staff and cost may influence decisions to offer therapies in different settings.

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