1 Infertility Unit, Department of Obstetrics and Gynecology, University of Milan, Milan and 2 Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
3 To whom correspondence should be addressed at: Infertility Unit, Department of Obstetrics Gynecology, Via Manfredo Fanti 6, 20122, Milan, Italy. Email: dadosomigliana{at}yahoo.it
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Abstract |
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Key words: health-related quality of life/infertility/IVF/SF-36
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Introduction |
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A specific and still poorly investigated issue in the field of infertility is represented by the impact that the need for IVF techniques may have on infertile couples (Eugster and Vingerhoets, 1999; Lukse and Vacc, 1999
; Fekkes et al., 2003
). We believe that this particular concern deserves great attention considering that, despite the vast worldwide diffusion of IVF, political and social reactions about these treatments are heterogeneous. In particular, some criticisms towards these technologies have been raised that might result in patients being ashamed of their condition. Moreover, performing IVF may be considered a highly stressful event per se since patients generally feel it is the last chance to conceive. To the best of our knowledge, no previous studies have assessed health-related quality of life (HRQoL) in patients selected for IVF using the validated Health Survey Short Form (SF-36) questionnaire which is the currently most widely used instrument in this regard (Wagner et al., 1998
; Ware and Gandek, 1998
; Ware et al., 1998
). The aim of the present study was to use SF-36 to assess HRQoL in a large sample of couples who were referred for IVF (1000 consecutive couples, 1000 women and 1000 men), to test the impact of clinical and socio-demographic determinants of health perception in this cohort and, finally, to compare results with those from the Italian normative population.
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Materials and methods |
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An ad hoc standardized questionnaire was set-up for this study, exploring two different areas: (i) demographic and clinical characteristics of patients such as gender, age, parity, education, duration of infertility (<5 versus <5 years), previous gynaecological or andrological surgery, IVF technique prescribed (classical IVF versus ICSI) and previous IVF attempts in other units; (ii) HRQoL variables. After a literature review, the Italian version of SF-36 was chosen to evaluate this aspect. This version has been previously validated and is described in detail elsewhere (Ware et al., 1993; Apolone and Mosconi, 1998
). Briefly, SF-36 is a generic tool that measures two major health concepts: physical and mental health with 36 items generating eight multi-item scales: physical functioning (PF), physical role limitation (RP), bodily pain (BP), general health, vitality, social functioning (SF), emotional role limitation (RE) and mental health (MH) (Table I). For each patient, scores are assembled using the Likert method for summated ratings, and then the raw scores are linearly transformed to 0 to 100 scales, with 0 and 100 assigned to lowest and highest possible value respectively. Higher transformed scores indicate better Health.
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Standardized scores (z-scores) were calculated by dividing the difference between the individual's raw score and the mean score of the corresponding Italian normative group (determined by age, gender and geographic distribution) by the SD of the Italian normative group. These standardized scores express the individual's distance from their normative group mean in terms of units of the SD of the distribution. Any score equal to the normative mean will be equivalent to a z-score of zero. Negative or positive z-scores are produced for persons falling below or above the mean respectively (Anastasi, 1988). Statistical analyses were performed by SAS® System (Cary, NC, USA).
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Results |
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Discussion |
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Some limits of our study design have to be considered. A possible selection bias may be related to the decision to interview subjects before performing IVF. This strategy may impact the results in two ways. First, patients who were shocked by the necessity of performing the procedure may have decided not to attempt it, thus they were not interviewed. Second, hope about success may have reduced the degree of psychological discomfort. On the other hand, submitting questionnaires prior to initiating IVF has allowed us to obtain a remarkably high adherence to the study protocol; indeed, the percentage of completed questionnaires was 96.8%. A significant impact of such a low rate of drop-out on results is unlikely. Alternative approaches such as questionnaires mailed to the cohort of patients selected for IVF presumably lead to an unsatisfactory rate of completed questionnaires. Previous studies using this strategy have reported a rate of adhesions of 3877% (Souter et al., 2002; Anderson et al., 2003
; Olivius et al., 2004
). Another possibility could have been to provide the questionnaire when the necessity for IVF was communicated to the patient; however, this approach appeared inadequate considering the temporal necessity for psychological elaboration.
A further limitation is related to the instrument used to assess subjective health status. At present, no validated health outcome measure exists to evaluate the quality of life of patients experiencing infertility. While SF-36 represents the most validated questionnaire to assess subjective health status, it might be argued that this instrument does not collect information on all the areas of well-being and functioning that may be important to patients suffering from infertility. On the other hand, this questionnaire currently remains the most appropriate and accepted instrument to assess HRQoL. Indeed, among the so-called generic questionnaires available in different languages, SF-36, because of its comprehensiveness, brevity and high standards of reliability and validity, has been translated by independent Italian teams since 1990. The launch of the International Quality of Life Project in 1991 has made possible the use of data from several comparable applications across the world (Wagner et al., 1998; Ware and Gandek, 1998
; Ware et al., 1998
). The standardized and accredited Italian translation used in the present study has become available after an exhaustive test in a representative sample of Italian citizens of >10 000 cases (Apolone et al., 1997
).
Several studies have suggested that the impact of infertility and its treatment is higher in women than in men (Collins et al., 1992; Oddens et al., 1999
; Lee et al., 2001
; Pasch et al., 2002
; Fekkes et al., 2003
). Pasch et al. (2002)
clearly demonstrate that having children was more important to women than men. Results from the present study are in line with these previous conclusions, at least in the subgroup of patients requiring IVF. Indeed, scores for all SF-36 scales were lower in females compared with males. These differences persisted even after adjusting for socio-demographic and clinical variables. On the other hand, it is worthwhile noting that females are generally known to report lower HRQoL scores compared with males using the SF-36 questionnaire (Apolone et al., 1997
; Apolone and Mosconi, 1998
). This profile may thus be independent of infertility complaints. To further clarify this issue, data were also analysed comparing separately women and men to a normative Italian population and stratifying for gender, age and geographical area. Surprisingly, as shown in Figure 2, men and women were extremely similar to the normative population in seven out of eight scales. A slight and non-relevant lower score in the MH scale was observed in women. Thus, overall, this analysis does not support the common assumption that women are more severely distressed by infertility status, at least among patients who were about to initiate an IVF cycle. To the best of our knowledge, previous studies which have evaluated separately women and men with infertility did not take into consideration this bias. Moreover, the comparison performed with the normative population has allowed us to document that, in general, the need for IVF does not severely impact subjective health profile. Indeed, for both women and men, variations from the normative population were within 0.25 SD for all scales. Lower scores were documented for PF and SF for both men and women. Women appeared to have a lower score also for MH. As previously mentioned, however, these variations appear to be slight, thus limiting the validity of inferences on these differences. Our results are in line with those reported by Fekkes et al. (2003)
who evaluated HRQoL in a similar albeit smaller population using a different questionnaire, the Sickness Impact Profile. However, these authors reported that the subgroup of young patients (aged <30 years) planning IVF experienced more social and emotional problems. Unfortunately, a similar subgroup analysis could not be performed in our study since only a few patients were aged <30 years. Reasons to explain discrepancies with previous reports that have documented an impact of infertility on HRQoL can herein only be hypothesized. First, it has to be considered that IVF programmes are entirely supported by the public health system in our Unit. As a consequence, emotions evoked by financial impact are presumably extremely reduced in our series. Second, new hopes related to the imminent IVF cycle in our cohort may have masked a certain rate of discomfort. For this reason, it is worthwhile noting that inferences from our results on all infertile patients cannot be done. Moreover, the observation that the need for IVF does not markedly impact on HRQoL does not mean that performing IVF or failure to achieve a pregnancy through IVF does not have deleterious effects. These latest two aspects were not specifically investigated in the present study. Finally, failure to observe a significant impact on our study population as a whole does not rule out that IVF may constitute a highly charged life event in specific subgroups of patients.
Recently, much attention has been paid to psychological reasons that may determine the elevated drop-out rate observed in women after their first IVF attempt. Psychological reasons have been reported to play a major role (Goverde et al., 2000; Olivius et al., 2004
; Smeenk et al., 2004
). Although our study was not specifically designed to address this issue, this finding is indirectly confirmed by the observation that patients who previously underwent IVF attempts in other centres had slightly lower scores in the scale of MH. In other words, failure to achieve a pregnancy through IVF but not the need for these techniques may significantly affect the HRQoL of infertile patients. It cannot also be excluded that other unsuccessful fertility treatments such as ovulation induction and/or intrauterine inseminations may influence emotions evoked by referral for IVF. This possibility was not investigated in our survey. Further studies specifically aimed to address these topics are required. Finally, our study provides evidence that duration of infertility does not significantly affect the psychological area of HRQoL. A slightly lower score was documented only in the scale of PF among patients who were seeking for children for a longer time. This finding is difficult to explain. Overall, it might be speculated that the duration of infertility does not markedly affect subjective health status in patients requiring IVF. The lower scores in this physical scale observed in patients with infertility lasting >5 years may be due to a selection bias. Indeed, patients with pain complaints may have postponed IVF more than those without these complaints. For instance, diseases such as endometriosis, pelvic inflammatory disease and seminal tract infections are well-known conditions associated with both infertility and pain. However, this hypothesis needs to be confirmed.
In summary, this study failed to document a significant influence of the need for IVF on subjective health status, at least when patients do not have to support the financial impact of the procedure. On the other hand, data from the literature and in part from the present study suggest that failure to achieve a pregnancy through IVF may have a relevant negative impact. Further studies are warranted in this area to clarify whether other subgroups of patients such as, for example, those with a worse prognosis, may be more severely affected by the need for IVF and to define the best clinical approach both to reduce patient drop-out after the first cycle of IVF and to attenuate post-failure impairment of HRQoL.
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Acknowledgements |
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References |
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Submitted on July 30, 2004; resubmitted on November 22, 2004; accepted on January 17, 2005.
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