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By Dr. Vibha Rai

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By Dr. Vibha Rai Development and evaluation of educational intervention to promote informed decision making regarding embryo transfer in IVF patients by Dr. Vibha Rai BSc, MBBS, MMedSci. Thesis submitted to the University of Nottingham for the degree of Doctor of Philosophy, February 2012 Acknowledgements ACKNOWLEDGEMENTS It has been a very good experience doing this PhD. I thank Prof. Cris Glazebrook for being my supervisor for this project, which the Infertility Research Trust, UK made it possible by giving the funds to carry out this research. I like to thank Mr. James Hopkisson, Clinical director, NURTURE for all the support he gave me throughout my project, right from the beginning, especially in data collection. This research would have been impossible without his help. I would like to thank Mr. George Ndukwe, Clinical director, CARE for allowing the data collection at Care fertility centre. I want to thank Prof. Bruce Campbell, Dr. Nick Fenning and Dr. M. Tomlinson, for developing the desire for further research within me. Acknowledgements ACKNOWLEDGEMENTS To ‘GOD’ for the blessings To my children, Pravi and Vipresh, just want to tell you both how blessed and proud I feel because of you. I don’t have words to describe my love for you two. “Love you both and will always be there for you.” To my husband, Dr. P C Rai, I am what I am today because of him. I could not have asked for a better life partner. Thank you for everything! To my parents, brothers and sisters for their love and support CONTENTS Chapters Title Pages Chapter-1 Are In-Vitro Fertilisation (IVF) twins at greater risk 1-79 of poor perinatal and neo-natal outcomes compared to IVF singletons? 1.1 Introduction 1-3 1.2 An overview of infertility and its treatment 3-5 1.3 Rates of multiple births associated with IVF treatment 5-9 1.4 Patho-physiology of Twin Births 9-9 1.5 Factors influencing increase in multiple births 9-14 1.6 Are twins a risk factor for preterm and prematurity? 14-21 1.7 Evidence for negative effects of twin births for child 21-34 and mother in IVF studies and in studies comparing naturally conceived twins and singletons 1.8 Is eSET effective in reducing multiple pregnancy 34-61 rates? 1.9 Cleavage stage versus blastocyst stage embryo 62-64 transfer 1.10 Role of Cryopreservation 64-66 1.11 Is eSET associated with better infant outcomes? 66-67 1.12 Factors influencing success of eSET 67-69 1.13 Cost comparison 69-72 1.14 Barriers to eSET 72-72 1.15 Conclusion 73-78 1.16 Aims of this thesis 79 Chapter-2 The impact of being born very premature on 80-96 neurobehavioural development in twins 2.1 Introduction 80-80 2.2 Aims 81-81 2.3 Method 81-83 2.4 Ethics approval 83-83 2.5 Analysis 83-83 2.6 Results 83-89 2.7 Discussion 90-96 Chapter-3 Development and preliminary validation of a 97-132 questionnaire to measure attitude to risk associated with twin IVF pregnancies and barriers to elective single embryo transfer 3.1 Attitude and behaviour 97-98 3.2 Clinicians’ attitudes to eSET and twin births 98-104 3.3 Patients’ attitude to eSET and twin pregnancies 104-112 3.4 Attitudes influenced by the timing of questioning 112-115 3.5 The Health Belief Model (HBM) 115-117 3.6 Aim 117-118 3.7 Method 118-120 3.8 Ethics approval 120-120 3.9 Analysis 120-120 3.10 Results 120-126 3.11 Discussion 126-132 I CONTENTS Chapters Title Pages Chapter 4 Compatibility of the ATIP scale in a patient 133-150 population 4.1 Introduction 133-134 4.2 Aims 134-135 4.3 Method 135-137 4.4 Ethics 137-137 4.5 Analysis 137-137 4.6 Results 138-145 4.7 Discussion 145-150 Chapter 5 Decision Aids 151-176 5.1 Introduction 151-153 5.2 Design of DA 153-154 5.3 Types of DA 155-158 5.4 Patient preference 158-159 5.5 Effectiveness of a DA 160-166 5.6 Clinicians’ attitudes to decisional aids 166-168 5.7 IVF and DA 169-170 5.8 Development of the decision aid leaflet 170-175 5.9 Conclusion 175-176 Chapter 6 A randomised controlled trial of a decision aid 177-199 leaflet to promote single embryo transfer in IVF patients 6.1 Introduction 177-181 6.2 Aims 181-182 6.3 Method 182-186 6.4 Ethics approval 186-186 6.5 Statistical analysis 187-187 6.6 Results 187-193 6.7 Discussion 193-199 Chapter 7 Discussion 200-232 7.1 Introduction 200-201 7.2 Role of regulation on embryo transfer 201-203 7.3 IVF practise around the world 203-206 7.4 Risk for mother and child 207-216 7.5 Elective single embryo transfer 216-218 7.6 Importance of health professionals in decision making 218-219 7.7 Need for intervention 219-225 7.8 Use of decision aid 225-227 7.9 Limitation of this study 227-229 7.10 Clinical implications of the thesis 229-231 7.11 Conclusion 231-232 References 233-277 II CONTENTS Tables Title Pages 1.1 Figures of IVF birth (HFEA Facts & Figures 2008) 16 1.2 Comparison between fresh single cycle SET with 49-50 single fresh cycle DET 1.3 Details of studies included in the review (Blake et al 61 2007) 1.4 Summary of costs to the NHS of singleton, twin and 71 triplet births resulting from IVF infertility treatment in the UK (RCOG 2006) 1.5 IVF regulations around the world (HFEA, 2010) 78 2.1 Infants’ Characteristics 84 2.2 Mothers’ Characteristics 85 2.3 MDI scores by twin status 86 2.4 MDI delay- Singletons and Twins 87 2.5 MDI index score Coefficients for all infants 88 2.6 PDI scores by twin status 89 2.7 PDI delay- Singletons and Twins 89 2.8 PDI index score Coefficients for all infants 90 3.1 Preferences for a Multiple Pregnancy in Infertile 106-107 Women (Glazebrook et al, 2007) 3.2 Variables important for decision-making in female and 111 male IVF patients who chose either one or two embryos to be transferred (Blennborn. et al 2005) 3.3 Demographics of participants 121 3.4 Risk and Benefits of Twin Birth Subscale with item 123 total correlations 3.5 Single Embryo Transfer Subscale with item-total 124 correlations 3.6 Mean sub scale scores by group 125 3.7 Number and percentage of health professionals 126 agreeing with statement 4.1 Item total correlations. A-Twin scale 138 4.2 Item total correlations-A-SET scale 139 4.3 Demographic characteristics of female patients 140 4.4 Factors influencing A-Twin scores 142 4.5 Factors influencing A-SET scores 143 6.1 Demographic details of participants – patients and 188 partners 6.2 Outcome variables in the whole group 189 6.3 Relationship between baseline attitudes and anxiety 190 and decision difficulty at embryo transfer 6.4 Change in attitude scores before and after embryo 191 transfer in participants receiving the decision aid leaflet 6.5A Clinical details about participants 192 6.5B Clinical details about participants 192 III CONTENTS Figures Title Pages 1.1 Rise in UK fertility (Office of National Statistics) 6 1.2 Increasing rate of twin pregnancy, BJOG Aug’04 8 1.3 Decreasing rate of higher order pregnancies after 8 1997, BJOG Aug’04 3.1 The attitude of Nordic IVF doctors towards what is 100 an acceptable twin pregnancy rate after ART. (Bergh et al, 2007) 3.2 The Health Belief Model (Becker 1974) applied to 117 eSET. Appendices Title 1 Information sheet study 2 2 Demographic questionnaire for different participant groups of study 2 with the long (44 questionnaire) ATIP scale 3 Short (20 questionnaire) ATIPS-R 4 Study 4 Ethics approval 5 Study 4- Patient/ Partner information pack; Consent form; Patient/ Partner demographic and ATIPS-R questionnaire 6 Follow-up questionnaire: Anxiety scale; Decision conflict scale; ATIPS-R; free post envelope 7 HFEA leaflet 8 Study leaflet Publications 2006 Presented at the International conference on “Controversies in Reproductive Medicine” 2006 Development and preliminary validation of the Attitudes to Twin IVF Pregnancies scale 2007 Abstract accepted as Poster in Society for Reproductive and Infant Psychology (SRIP) Conference 2007 St Anne's College, Oxford-Validation of the Attitudes to Twin IVF Pregnancies scale in a patient population 2008 Presented at infertility conference at Middlesex university, UK 2008, Validation of the shorter Attitudes to Twin IVF Pregnancies scale in patient and IVF specialist groups 2008 Abstract published in Journal of Reproductive and Infant Psychology 2011 Paper published in the Journal of Assisted Reproduction and Genetics IV CONTENTS V Abstract ABSTRACT Increasing the uptake of elective single embryo transfer is necessary to achieve the 10% HFEA limit for multiple IVF births in 2011. This thesis aims to explore patients’ and clinicians’ attitudes to eSET and to promote effective decision making regarding embryo transfer. Study1compared neurobehavioural outcomes between twins and singletons in a prospective study of infants born very preterm (n=233). Despite having older (p=0.025) and higher social class (p=0.023) mothers, twins had the same risk of cognitive impairment at 2 years as singletons. In study 2, a 44 item Attitudes to Twin Pregnancy scale (ATIPS) was developed and administered to a sample of clinicians, medical students and conference delegates (n=411).
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