Cancer, Fertility and Me: Developing and Testing a Novel Fertility Preservation Patient Decision Aid to Support Women at Risk of Losing Their Fertility Because of Cancer Treatment.

Background: Women with a new cancer diagnosis face complex decisions about interventions aiming to preserve their fertility. Decision aids are more effective in supporting decision making than traditional information provision. We describe the development and field testing of a novel patient decision aid designed to support women to make fertility preservation treatment decisions around cancer diagnosis. Methods: A prospective, mixed-method, three stage study involving: 1) co-development of the resource in collaboration with a multi-disciplinary group of key stakeholders including oncology and fertility healthcare professionals and patient partners (n=24), 2) alpha testing with a group of cancer patients who had faced a fertility preservation treatment decision in the past (n=11), and oncology and fertility healthcare professionals and stakeholders (n=14) and, 3) beta testing with women in routine care who had received a recent diagnosis of cancer and were facing a fertility preservation treatment decision (n=41) and their oncology and fertility healthcare professionals (n=3). Ten service users recruited from a closed Breast Cancer Now Facebook group and the support group Cancer and Fertility UK also provided feedback on CFM via an online survey. Results: A 60-page paper prototype of the Cancer, Fertility and Me patient decision aid was initially developed. Alpha testing of the resource found that overall, it was acceptable to cancer patients, healthcare professionals and key stakeholders and it was considered a useful resource to support fertility preservation treatment decision-making. However, the healthcare professionals felt that the length of the patient decision aid, and elements of its content may be a barrier to its use. Subsequently, the prototype was reduced to 40 pages. During beta testing of the shortened version in routine care, women who received the resource described its positive impact on their ability to make fertility preservation decisions and support them at a stressful time. However, practical difficulties emerged which impacted upon its wider dissemination in clinical practice and limited some elements of the evaluation planned. Discussion: Women receiving the decision aid within the cancer treatment pathway found it helped them engage with decisions about fertility preservation, and make better informed, values-based care plans with oncology and fertility teams. More work is needed to address access and implementation of this resource as part of routine oncology care pathways.

Outcomes of delivering a fertility preservation service for women with cancer over a 12-year period at a UK assisted conception unit.

This service evaluation aimed to appraise the delivery of a fertility preservation service for women with cancer which was established in 2005 as part of an Assisted Conception Unit. First, the ACU-database was interrogated between 08/2005 and 01/2017; revealing 174 women received referrals over the 12-year period with a steady referral increase each year. Demographic analyses revealed factors, such as being partnered, to be strong indicators of whether women would seek FP or not. To improve service provision, women who had consented to be contacted for audit, administrative and research purposes, received questionnaires to ascertain their perspectives on the FP decision-making process, their outcomes and ACU after-care. The majority perceived their experience as excellent due to the care they received from ACU staff, speed and efficiency in service delivery. The increasing number of referrals since 2005 is reassuring. However, this audit also highlighted shortcomings of the service, such as limited awareness of the fertility counselling service and lack of after-care.IMPACT STATEMENTWhat is already known on this subject? There has been an increase in women diagnosed with cancer undergoing fertility preservation (FP) before starting potential gonadotoxic treatment. Offering FP to these women is essential as the ability to have future children is often perceived as equally as important as survivorship, and a source of hope for the future.What do the results of this study add? This study presents a service evaluation, across a 12-year period, of delivering FP services to women with cancer in one UK Assisted Conception Unit (ACU). Women's experiences of the service were evaluated to enhance service delivery and make recommendations for clinical practice.What are the implications of these findings for clinical practice and/or future research? The current service evaluation demonstrated increased rates of FP referral over a 12-year period for women with cancer. While this increasing number is reassuring and reflecting increased awareness among professionals and patients; shortcomings in the care pathway were also found: women reported limited opportunity to see fertility counsellors and desired better after care. This information may also be of benefit to other ACUs seeking to enhance and improve service provision in the care of women with cancer, contemplating fertility preservation.

Preserving fertility in women with cancer (PreFer): Decision-making and patient-reported outcomes in women offered egg and embryo freezing prior to cancer treatment.

OBJECTIVE: Women of childbearing age with new cancer diagnoses have to make rapid decisions about fertility preservation (FP) before starting cancer treatment (CT). The aim of the PreFer study was to explore this FP decision-making process and its impact on patient-reported outcomes (PROMs) and health-related quality of life (HRQoL). METHODS: A prospective, mixed-methods design was used (questionnaires, in-depth interviews). Interviews were analysed using thematic analysis. Fifty-eight women with new cancer diagnoses were recruited. Comparisons were made between women who declined FP referral in oncology (Group1) and women who chose referral (Group2). Group 2 was further split into those who had some FP (2A) and those who did not (2B). Questionnaires and PROMs were administered prior to and after the fertility consultation, before the start of CT and 3 months post CT. Interviews were conducted with one participant from Group 2. RESULTS: HRQoL was negatively affected, particularly depression. Women's lack of understanding about the relationship between CT and fertility were evident. Five themes emerged from the interviews as barriers and facilitators to the FP decision-making process. CONCLUSION: The results indicate that better information and support resources aimed at women to support their decision making are needed, such as patient decision-aids. Women from Group 1 were found to suffer significantly worse depression compared with the general UK population, highlighting the need for psychological support in the FP care-pathway and for research exploring the contributions of depression and hopelessness to the decision-making process.

Induced endometrial trauma (endometrial scratch) in the mid-luteal menstrual cycle phase preceding first cycle IVF/ICSI versus usual IVF/ICSI therapy: study protocol for a randomised controlled trial.

INTRODUCTION: Endometrial trauma commonly known as endometrial scratch (ES) has been shown to improve pregnancy rates in women with a history of repeated implantation failure undergoing in vitro fertilisation (IVF), with or without intracytoplasmic sperm injection (ICSI). However, the procedure has not yet been fully explored in women having IVF/ICSI for the first time. This study aims to examine the effect of performing an ES in the mid-luteal phase prior to a first-time IVF/ICSI cycle on the chances of achieving a clinical pregnancy and live birth. If ES can influence this success rate, there would be a significant cost saving to the National Health Service through decreasing the number of IVF/ICSI cycles necessary to achieve a pregnancy, increase the practice of single embryo transfer and consequently have a large impact on risks and costs associated with multiple pregnancies. METHODS AND ANALYSIS: This 30-month, UK, multicentre, parallel group, randomised controlled trial includes a 9-month internal pilot and health economic analysis recruiting 1044 women from 16 fertility units. It will follow up participants to identify if IVF/ICSI has been successful and live birth has occurred up to 6 weeks post partum. Primary analysis will be on an intention-to-treat basis. A substudy of endometrial samples obtained during the ES will assess the role of immune factors in embryo implantation. Main trial recruitment commenced on January 2017 and is ongoing.Participants randomised to the intervention group will receive the ES procedure in the mid-luteal phase of the preceding cycle prior to first-time IVF/ICSI treatment versus usual IVF/ICSI treatment in the control group, with 1:1 randomisation. The primary outcome is live birth rate after completed 24 weeks gestation. ETHICS AND DISSEMINATION: South Central-Berkshire Research Ethics Committee approved the protocol. Findings will be submitted to peer-reviewed journals and abstracts to relevant national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN23800982; Pre-results.

What factors hinder the decision-making process for women with cancer and contemplating fertility preservation treatment?

BACKGROUND: Although fertility preservation (FP) treatment options have increased, the existing evidence suggests that many women with cancer do not feel well supported in making these decisions, but find them stressful and complex and fail to take up fertility care at this crucial time. Whilst existing reviews have all made important contributions to our understanding of the FP decision-making process, none of them examine solely and specifically these processes for women of reproductive age with a diagnosis of any cancer, leaving a gap in the knowledge base. Given the expectation that care is patient-centred, our review aims to address this gap which may be of help to those managing patients struggling to make difficult decisions in the often brief period before potentially sterilizing cancer treatment is started. OBJECTIVE AND RATIONALE: Underpinning this narrative review was the question 'What factors hinder the decision-making process for women with any cancer and contemplating FP treatment?' Our objectives were to (i) assess and summarize this existing literature, (ii) identify the factors that hinder this decision-making process, (iii) explore to what extent these factors may differ for women choosing different methods of FP and (iv) make recommendations for service delivery and future research. SEARCH METHODS: A systematic search of the medical and social science literature from the 1 January 2005 up to the end of January 2016 was carried out using three electronic databases (Web of Science (PubMed), Ovid SP Medline and CINAHL via Ebsco). Included in the review were quantitative, qualitative and mixed-method studies. Reference lists of relevant papers were also hand searched. From the 983 papers identified, 46 papers were included. Quality assessment was undertaken using the Mixed Methods Appraisal Tool and thematic analysis was used to analyse the data. OUTCOMES: From the analysis, 6 key themes with 15 sub-themes emerged: (i) fertility information provision (lack of information, timing of the information, patient-provider communication); (ii) fear concerning the perceived risks associated with pursuing FP (delaying cancer treatment, aggravating a hormone positive cancer and consequences of a future pregnancy); (iii) non-referral from oncology (personal situation, having a hormone positive cancer, FP not a priority and transition between service issues); (iv) the dilemma (in survival mode, whether to prioritize one treatment over another); (v) personal situation (parity, relationship status) and (iv) costs (financial concerns). WIDER IMPLICATIONS: This review has found that a wide range of internal and external factors impact the FP decision-making process. Key external issues related to current service delivery such as the provision and timing of FP information, and lack of referral from oncology to the fertility clinic. However, internal issues such as women's fears concerning the perceived risks associated with pursuing FP also hindered decision-making but these 'risks' were typically overestimated and non-evidence based. These findings suggest that the implementation of a range of decision support interventions may be of benefit within the clinical care pathway of FP and cancer. Women would benefit from the provision of more evidence-based FP information, ideally received at cancer diagnosis, in advance of seeing a fertility specialist, for example through the implementation of patient decision aids. Healthcare professionals in both oncology and fertility services may also benefit from the implementation of training programmes and educational tools targeted at improving the communication skills needed to improve collaborative decision-making and deliver care that is patient-centred. Exploration of the current barriers, both intellectual and practical, that prevent some patients from accepting FP will help care providers to do better for their patients in the future. Finally, the extent to which a poorer prognosis and moral, ethical and religious beliefs influence the FP decision-making process also warrant further research.

A prospective randomized controlled trial of Wallace and Rocket embryo transfer catheters.

The aim of this study was to compare the efficacy of two embryo transfer catheters: Wallace and Rocket Embryon in an IVF programme of a tertiary referral university centre. A total of 308 patients undergoing embryo transfer were prospectively randomized to either a transfer with the Wallace catheter or a transfer with the Rocket catheter. The main outcome measure in this study was the clinical pregnancy rate, and secondary outcome measures included implantation rate, visibility of the catheter under ultrasound, number of retained embryos post transfer, and whether change of catheter was required. In addition, patient discomfort during the procedure was recorded. Pregnancy and implantation rates were similar when Wallace or Rocket catheters were used. However, for the Rocket catheter, the tip was more often clearly seen on ultrasound and it had a lower rate of retained embryos in the catheter after transfer (P < 0.05). Experience with different transfer catheters is recommended for difficult cases.