Relationship Between IVF Treatment and Miscarriage in the UK - Article Example

Relationship between IVF (in vitro Fertilisation) Treatment and Miscarriage in the United Kingdom: Focusing on the Emotional Experience Research Proposal Introduction The past three decades have witnessed significant advances in the field of assisted human conception. Along with improvements in the areas of ovarian stimulation, embryo culture, and cryobiology, the discipline of assisted reproductive technology has witnessed the introduction of assisted fertilization through intracytoplasmic sperm injection, the development of techniques to remove and perform genetic analysis on polar bodies or blastomeres, and the enhancement of methods for assessing the viability of the developing conceptus (de Klerk et al., 2007, 2554-2558). It has been often highlighted by the practice community that together with the advancements in assisted human conception should come careful monitoring of outcomes, including the children conceived. Quite often, the outcome is more detrimental than the visible ones, which are minor and negligible (Olivius et al., 2004, 258-261). The social and psychological impacts of this enormous advancement of technology are points of debate from the very beginning, and therefore considerable research has been devoted to find out the truth and balance between the extraordinary fruit of technology, mental dilemma regarding acceptability of the less worse in comparison to the worst (Verberg et al, 2008, 2050-2055) so the best possible outcomes can be delivered to the clients who are now consumers with great financial stakes (Smeenk et al., 2001, 1420-1423). Background It has been already cited in the literature that emotional components in IVF irrespective of a successful outcome are very intense, and emotional components of the participants often influence outcomes (de Klerk et al., 2003, xviii47-xviii48). Added to it, the resultant gloom, grief, and depression in the couple from a miscarriage would further make the outcome precarious in the next attempt (Brady et al., 2008, 186-190). Knowledge in this area is a necessity since it is often invisible, and the practitioner must consider these effects with a priority, since overlooking these is unethical and unprofessional, leading to a situation of unaccountability. There is evidence of adverse emotional experiences in such patients; however, the questions how far and how much intense and important these are need to be answered in order to address the gap in research and to design an intervention (Cumming et al., 2007, 1138-1145). Evidence from literature will be sought to design a methodology that can address these questions, and validity and reliability of these methods will be sought. A proposal for data collection will be made, and prospective synthesis of the findings will be undertaken so the utility for practice can be determined. Brief Literature Review A literature review with the key words, "in vitro fertilisation", "miscarriage", "emotional experience", "psychological stress", "assisted conception", "assisted reproduction" and "United Kingdom" was conducted from appropriate databases, and research articles were located. The initial articles were narrowed down to combine key words, and ultimately 5 studies were selected for review. The findings are presented below. Although not recent, the study by Mahlstedt et al. highlights the basic tenets of the emotional experience of the couples undergoing IVF. The aim of the study was to undertake a self-administered questionnaire study for a period of 6 months on 94 IVF and embryo transfer patients with the objectives of acknowledging their emotional states and of developing strategies for providing emotional support. This study revealed that 77% of the participants reported that they perceive the loss of control as the most stressful dimension leading to feelings of vulnerability and intense stress. Aside from these they reported a wide range of emotions during a brief period of time. This emotional strain was a major factor of consideration when the decision about a repeat procedure is to be taken, which is exactly the case in miscarriages associated with IVF (Mahlstedt, Macduff, and Bernstein, 1987, 232-236). In a comparatively recent study, Boivin and Takefman examined the stress associated with IVF in concurrence with other physical and relational variables. The most stressful about IVF is not the medical procedures per se, but the fact of trying to become pregnant and not succeeding. Miscarriage associated with IVF adds another dimension to the failure and is associated with a grief response. This was combined interview based on psychometric parameters and demographic and medical profile statistical comparison study with 20 participants. A daily record keeping sheet of average 11 emotional descriptions such as nervous, anxious, moody, pessimistic, angry, frustrated, tense, irritable, hassled, touchy, sensitive, and stressed; physical discomfort parameters; intimacy with spouse; and optimism about pregnancy were recorded at different points. Statistical analysis of the data resulted in findings that indicate the type of reactions. This study also indicates the usefulness of psychosocial interventions during these emotional responses (Boivin and Takefnan, 1996, 903-907). Studies done by Newman and Zouves on 33 female IVF participants and 18 of their spouses through interview questionnaire have shown that participants undergoing in vitro fertilisation suffer from anxiety, depression, loss of control, and positive feelings. IVF even without miscarriage is associated with certain risks; the most significant are the chances of repeat miscarriage, sense of loss, and another failure. With expectations regarding outcomes and financial implications of IVF, a miscarriage bears a threat and apprehension in the couple's mind. Female participants' anxiety and loss of control were very frequent. At the completion of the treatment, the couples have reported high rate of depression, desiring support service. If miscarriage occurs, the psychological effects and the emotional experience result from grief due to loss, disappointment due to failure, and frustration due to financial burden. Very few studies have explored the emotional response of the couple following a miscarriage in cases of IVF, although emotional experiences have been dealt with IVF per se and miscarriage separately (Newman and Zouves, 1991, 322-328). Redshaw and colleagues conducted their study through open-ended semi-structured questionnaire postal interview to investigate the experience of women involving 230 participants who have undergone IVF. This study is part of a longitudinal cohort research programme on a nationally representative sample in the UK. The text responses of these questions were qualitatively analysed by thematic analysis. The emergent themes were the role of luck and good fortune, lack of choice and control, emotional and physical pain, becoming a nonperson, the need for stoicism and sacrifice, number and measurement, lost and wasted time, differences in care, financial and emotional costs, and need for fairness and equity. Many patients see the end results of such processes to be "prized" with a child, where the treatment process, waiting, and distress are considered a "price" to be paid to achieve the goal. When the process was associated with difficulties, the all consuming feeling was "I will never become a parent." It is clear that IVF itself is an emotionally and physically difficult process where every failure, such as, a miscarriage, the feelings of never becoming a parent is revisited, even after success (Redshaw, Hockley, and Davidson, 2007, 295-304). Since no study that involved the emotional experiences of miscarriage after an IVF was able to be located, it was decided to review a study of emotional experiences following miscarriage in UK and later collate the findings. It is obvious that the intensity and impact of these emotional experiences will be far excruciating in multiple dimensions in such cases. In the study by Simmons et al., done as a part of the UK National Women's Health Study, a representative survey of women's reproductive histories. The authors performed a qualitative thematic analysis of the detailed narratives of the emotional experiences of 172 women with miscarriage, which is considered to be the most common adverse outcome in any form of pregnancy. This is in general a traumatic experience which is considered by patients to be unsupported by caregivers. Many women do not get an explanation of their miscarriage, and the emotional experience for them is a sense of loss that is engaged in complex searches of meaning, often linked to their moral deservedness as mothers. The lay understanding of pregnancy loss grossly differs from its biomedical understanding. The authors conclude that these women do not experience miscarriage as a routine complication, and depending on the behaviour pattern, more support and information are needed (Simmons et al., 2006, 1936-1946). Research Problem What are the adverse emotional responses of women who have miscarriage following assisted reproductive technology through IVF' Aims To determine the incidence, parameters, and dimensions of these adverse emotional experiences from IVF culminating into miscarriage in participating couples. Objectives Following synthesis of findings from the literature review, a study will be designed that tends to effectively examine the intensity, dimensions, and themes of adverse emotional responses of patients sustaining miscarriage following IVF, so an effective psychosocial support can be designed to improve the outcomes. Methodology The convenience sampling of all couples admitted to an infertility treatment program by IVF will be utilised in a stipulated time period of 2 years and they will be requested to participate in the study. The inclusion criteria would be indications of IVF treatment, a positive history of miscarriage, age less than 41 years, stable relationship with spouse, no baseline psychological problems at entry. Information for all prospective participants will be gathered in a standard protocol (de Klerk et al., 2005, 1333-1338). Those who do not fulfill these criteria and those who did not consent will be excluded. These criteria are important to increase generalizability of the study results. Demographic data and infertility history will be collected from all women by standardized questionnaire. Daily Record Keeping Chart questionnaire is an infertility specific tool with 21 items assessed on a 4 point Likert scale representing emotional reactions of patients undergoing infertility treatment (Boivin, 1997). This will be modified with the addition of another 4 items based on open-ended questions regarding their experience on miscarriage. The subscales that will be assessed are depression/anger, uncertainty, positive affect, and anxiety ranging 0-12. This is a tool with good criterion-related validity (Boivin, 2003, 2325-2341) with other conceptual scales, for example, Spielberger State Anxiety Inventory (Boivin, 1997). Although very reliable, there was considerable overlap between the negative subscales. The reliability of this tool is further established by its good internal consistency through Cronbach coefficient alphas ranging from 0.76 to 0.88 for the individual subscales. Ethics The study will be reviewed by the appropriate ethical review board for human research and the University review board. The participants will be given free will to participate and withdraw following verbal explanation of the research methods, and they will be included in the study after a written and verbal consent. They will be ensured that their personal identity will remain undisclosed, and confidentiality of their statements will be maintained at any cost. There will be no coercion in any form to induct them in the study, and they will be ensured that their responses, participation, and withdrawal will not affect their care in any given point in time. The review board will examine during the study at the setting to ensure conformity to ethical principles. Results Student's t-test will be utilised to analyse demographic data for continuous variables and chi-squared test will be used for categorical variables. Stage scores of both positive and negative affect will be calculated by averaging daily scores on the DRK within each treatment stage. These will be arranged in groups. Analyses of covariance will be conducted for group comparisons of both positive and negative affects during each individual treatment stage. A parallel thematic analysis of the content of the remarks included in the questionnaire will be done, and emerging themes will be analysed. These will be correlated with the quantitative data extracted earlier for individual groups. Correlation coefficients will be determined to explore the relationships. Effect sizes will be calculated by Cohen D. Resource Implications and Costs This is study over a period of 2 years. Therefore it would need considerable resources. However, since no intervention has been planned, the only cost would be the costs for administering the questionnaire through a trained social worker. Apart from the other usual costs of research and remunerations for researcher, statisticians, and office expenses, no other extra cost is involved. Conclusion This research involves an important yet understudied aspect of IVF. The study design and the tool deal with conceptual parameters, which can be very vague at times, and a well executed and validated questionnaire is necessary for that. From studies, no specific tool could be located that includes miscarriage experiences as a parameter. Thus improvisation may affect reliability of the data. Negative affects consistently overlap, and therefore there may be multiplication of the significance. There are no measures in this study to counter that. Although this study can identify the experiences, due to lack of intervention in the design, it will fail to suggest measures to improve outcomes. However, this study would be unique to create a base for further research in this area where all these pitfalls can be addressed. References Boivin, J. and Takefnan, JE., (1996). Impact of the in-vitro fertilization process on emotional, physical and relational variables. Human Reproduction; 11: 903 - 907. Boivin, J., (1997). The Daily Record Keeping Chart: Reliability and validity. Paper presented at the British Psychological Society Special Group in Health Psychology Annual Conference, Southampton, UK, July 1997. Boivin, J., (2003). A review of psychosocial interventions in infertility. Social Science and Medicine; 57,2325-2341. Brady, G., Brown, G., Letherby, G., Bayley, J., and Wallace, LM., (2008). Young women's experience of termination and miscarriage: A qualitative study. Human Fertility; 11(3): 186-90. Cumming, GP., Klein, S., Bolsover, D., Lee, AJ., Alexander, DA., Maclean, M., and Jurgens, JD., (2007). The emotional burden of miscarriage for women and their partners: trajectories of anxiety and depression over 13 months. BJOG; 114(9): 1138-45. de Klerk, C., Hunfeld, JAM., Macklon, NS., and Passchier, J., (2003). Little effect of one psychosocial counselling session on emotional distress experienced by couples undergoing infertility treatment. Human Reproduction; 18 (Suppl 1), xviii47-xviii48. de Klerk, C., Hunfeld, J.A.M., Duivenvoorden, H.J., den Outer, M.A. , Fauser, B.C.J.M., Passchier, J., and Macklon, N.S., (2005). Effectiveness of a psychosocial counselling intervention for first-time IVF couples: a randomized controlled trial. Human Reproduction; 20: 1333 - 1338. de Klerk, C., Macklon, N.S., Heijnen, E.M.E.W., Eijkemans, M.J.C., Fauser, B.C.J.M., Passchier, J., and Hunfeld, J.A.M., (2007). The psychological impact of IVF failure after two or more cycles of IVF with a mild versus standard treatment strategy. Human Reproduction; 22: 2554 - 2558. Mahlstedt, PP., Macduff, S., and Bernstein, J., (1987). Emotional factors and the in vitro fertilization and embryo transfer process. Journal of In Vitro Fertilization and Embryo Transfer; 4(4): 232-6. Newman, NE and Zouves, CG., (1991) Emotional experiences of in vitro fertilization participants. Journal of In Vitro Fertilization and Embryo Transfer; 8(6): 322-8. Olivius, C., Friden, B., Borg, G., and Bergh, C., (2004). Why do couples discontinue in vitro fertilization treatment' A cohort study. Fertility Sterility; 81, 258-261. Redshaw, M., Hockley, C., and Davidson, LL., (2007). A qualitative study of the experience of treatment for infertility among women who successfully became pregnant. Human Reproduction; 22: 295 - 304. Simmons, RK., Singh, G., Maconochie, N., Doyle, P., and Green, J., (2006). Experience of miscarriage in the UK: qualitative findings from the National Women's Health Study. Social Science Medicine; 63(7): 1934-46. Smeenk, JMJ., Verhaak, CM., Eugster, A., van Minnen, A., Zielhuis, GA., and Braat, DDM., (2001). The effect of anxiety and depression on the outcome of in-vitro fertilization. Human Reproduction; 16,1420-1423. Verberg, M.F.G., Eijkemans, M.J.C., Heijnen, E.M.E.W., Broekmans, F.J., de Klerk, C., Fauser, B.C.J.M., and Macklon, N.S., (2008). Why do couples drop-out from IVF treatment' A prospective cohort study. 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