School of Psychology, Cardiff University, Tower Building, 70 Park Place, Cardiff, CF10 3AT, UK.
Hum Reprod. 2021 Apr 20;36(5):1339-1352. doi: 10.1093/humrep/deab040.
What is willingness, preference and decision-making about planning for the possibility of needing multiple cycles of IVF/ICSI treatment among patients consulting for a first or repeat stimulated IVF/ICSI cycle?
The majority of patients seem to value the opportunity to plan for multiple cycles of treatment while acknowledging both possible challenges and benefits of doing so and decisions that might need to be made in advance.
Patients have strong intentions to do treatment to achieve pregnancy and approximately 48-54% continue treatment when confronted with a failed cycle, undergoing at least three complete cycles of treatment. However, there is inconsistency between this apparent willingness to do multiple cycles of treatment and the way treatment is currently planned on a cycle-by-cycle basis with patients.
STUDY DESIGN, SIZE, DURATION: The study was of cross-sectional design, comprising a mixed-methods English online survey posted between November 2019 and March 2020. Eligibility criteria were being a patient who had had a consultation to start a stimulated cycle of IVF/ICSI for the first time or for a repeat stimulated cycle after an unsuccessful cycle in the eight weeks prior to survey completion. Individuals were also required to be aged 18 or older (upper age limit of 42 years for women) and able to respond in English. In total 881 clicked on the survey link, 118 did not consent, 41 were excluded after data screening, 57 did not meet the inclusion criteria, 331 started the survey but did not complete it, 28 had missing data on critical variables (e.g., age) and 306 completed the survey (40.1% completion, 57 men, 249 women).
PARTICIPANTS/MATERIALS, SETTING, METHODS: Participants were allocated to either the willing or unwilling to plan for multiple cycles of treatment group based on their responses to three variables: willingness to plan for three complete cycles, whether they would choose to have another cycle of IVF and whether they would continue treatment after an unsuccessful cycle. Quantitative questions gathered data on preferences towards planning for multiple cycles (i.e., attitudes, subjective norms and perceived behavioural control), challenges, benefits of planning for multiple cycles, decisional conflict experienced and treatment decisions involved in planning for multiple cycles. Demographic, fertility and fertility treatment information were also collected. Qualitative questions gathered textual data on other perceived benefits and challenges of planning for multiple cycles and solutions to the challenges. Descriptive and inferential statistics were used on quantitative data. Thematic analysis (inductive coding) was performed on the textual data.
Overall, 73.2% (n = 224) of participants had had a consultation to start a first cycle of IVF/ICSI. Participants were on average 33 years of age and had been trying to conceive for three years. A total of 63.07% (n = 193) were university educated. A total of 56% (n = 172) of participants were willing to plan for multiple cycles of IVF/ICSI in advance of treatment. Repeated measures ANOVA, t-tests and chi-square analysis showed the willing group to be significantly more likely to have been in a relationship for longer (p<.05), have higher education (p<.05) and be resident in the United Kingdom (p<.05). The willing group had positive attitudes towards planning for multiple cycles (p<.001) and stronger agreement with subjective norms (p<.001), perceived behavioural control (p<.001), benefits of planning for multiple cycles (p<.01) and felt able and attached more importance to making treatment decisions in advance of treatment (p<.05). Data saturation was achieved for the thematic analysis of textual data which revealed a total of four other challenges (e.g., less decisional freedom) and six other benefits (e.g., having a realistic view of treatment) to planning for multiple cycles. Qualitative analysis also revealed that most patients could anticipate and provide solutions for the nine challenges of planning for multiple cycles (e.g., using flexible working for the negative effect of treatment on work).
LIMITATIONS, REASONS FOR CAUTION: Limitations included the outcome measure being willingness to plan for multiple cycles rather than actual multi-cycle planning behaviour. The unwilling group represented a heterogeneous group with possibly unknown motivational coherence (e.g., definitely against planning, ambivalent about planning). Other limitations included the cross-sectional nature of the survey and the recruitment source.
Treatment consultations about undergoing fertility treatment could re-frame treatment to be a multi-cycle process in line with patient's willingness, preference and decision-making. This multi-cycle approach could empower patients and clinicians to discuss treatment expectations realistically and formulate fully informed treatment plans that take account of the high likelihood of cycle failure in addition to the treatment decisions that may need to be made during treatment when a cycle fails. This multi-cycle approach could help us support patients in adhering to their treatment plans even when faced with challenges, and help ascertain the level of treatment engagement possible to achieve parenthood goals.
STUDY FUNDING/COMPETING INTEREST(S): This project is funded by an Investigator-Sponsor Non-interventional Study from Merck Serono Ltd (MS200059_0010). Professor Boivin reports personal fees from Merck KGaA, Darmstadt, Germany, Merck AB an affiliate of Merck KGaA, Darmstadt Germany, Theramex, Ferring Pharmaceuticals A/S, grant from Merck Serono Ltd, outside the submitted work and that she is co-developer of Fertility Quality of Life (FertiQoL) and MediEmo app. Dr. Gameiro reports consultancy fees from Ferring Pharmaceuticals A/S, Access Fertility and SONA-Pharm LLC, and grants from Merck Serono Ltd. Dr. Harrison declares no conflicts of interest.
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在咨询首次或重复刺激 IVF/ICSI 周期时，患者对需要多次 IVF/ICSI 治疗周期的计划意愿、偏好和决策是什么？
大多数患者似乎都希望有机会为多次治疗周期做计划，同时承认这样做的可能挑战和益处，以及可能需要提前做出的决策。
患者有强烈的治疗意愿以实现怀孕，大约 48-54%的患者在一个周期失败后会继续治疗，至少完成三个完整的治疗周期。然而，在患者目前基于周期的治疗计划方式与这种明显的多次治疗意愿之间存在不一致性。
研究设计、规模、持续时间：该研究为横断面设计，包括 2019 年 11 月至 2020 年 3 月期间进行的一项混合方法英语在线调查。入选标准是在完成调查前八周内咨询过首次刺激周期 IVF/ICSI 或因前一次刺激周期失败而咨询过重复刺激周期的患者。患者还必须年满 18 岁（女性年龄上限为 42 岁），能够用英语作答。共有 881 人点击了调查链接，118 人不同意，41 人在数据筛选后被排除，57 人不符合纳入标准，331 人开始调查但未完成，28 人关键变量（如年龄）缺失，306 人完成了调查（完成率为 40.1%，57 名男性，249 名女性）。
参与者/材料、设置、方法：根据参与者对三个变量的回答，将他们分配到愿意或不愿意计划多次治疗周期的组：计划进行三个完整周期的意愿、是否选择进行另一个周期的 IVF 以及在一个周期失败后是否会继续治疗。定量问题收集了对计划多次治疗周期的偏好（即态度、主观规范和感知行为控制）、挑战、计划多次治疗周期的益处、计划多次治疗周期时经历的决策冲突以及计划多次治疗周期所涉及的治疗决策的数据。还收集了人口统计学、生育力和生育治疗信息。定性问题收集了关于计划多次治疗周期的其他感知益处和挑战以及解决这些挑战的方案的文本数据。对定量数据进行描述性和推断性统计，对文本数据进行主题分析（归纳编码）。
总的来说，73.2%（n=224）的参与者咨询了开始第一次 IVF/ICSI 周期的问题。参与者的平均年龄为 33 岁，尝试怀孕已三年。共有 63.07%（n=193）的参与者接受过大学教育。共有 56%（n=172）的参与者愿意在治疗前提前计划多次 IVF/ICSI 周期。重复测量方差分析、t 检验和卡方分析表明，愿意组更有可能处于较长时间的恋爱关系（p<.05）、接受更高的教育（p<.05）和居住在英国（p<.05）。愿意组对计划多次治疗周期的态度更为积极（p<.001），对主观规范（p<.001）、感知行为控制（p<.001）、计划多次治疗周期的益处（p<.01）的认同更强，并且能够并更重视在治疗前提前做出治疗决策（p<.05）。对文本数据的主题分析达到了数据饱和，共发现计划多次治疗周期的其他四个挑战（例如，决策自由度降低）和六个其他益处（例如，对治疗有现实的看法）。定性分析还表明，大多数患者可以预测并为计划多次治疗周期的九个挑战（例如，将治疗对工作的负面影响用于灵活工作）提供解决方案。
局限性、谨慎的原因：局限性包括衡量标准是计划多次治疗周期的意愿，而不是实际的多次治疗周期计划行为。不愿意组代表了一个具有未知动机一致性的异质群体（例如，绝对反对计划，对计划犹豫不决）。其他局限性包括调查的横断面性质和招募来源。
关于进行生育治疗的咨询可以将治疗重新定义为符合患者意愿、偏好和决策的多周期过程。这种多周期方法可以使患者和临床医生能够现实地讨论治疗期望，并制定充分知情的治疗计划，除了在一个周期失败时可能需要做出的治疗决策外，还要考虑到周期失败的高可能性。这种多周期方法可以帮助我们支持患者坚持他们的治疗计划，即使面临挑战，并帮助确定实现父母目标的可能的治疗参与程度。
研究资金/利益冲突：该项目由默克雪兰诺有限公司（MS200059_0010）资助的一项由调查员发起的非干预性研究。教授博伊文报告说，她从默克 KGaA、达姆施塔特、德国、默克 AB 默克 KGaA、达姆施塔特德国、Theramex、费林制药公司、Merck Serono Ltd 获得个人酬金，作为 Fertility Quality of Life（FertiQoL）和 MediEmo 应用程序的共同开发者。Gameiro 博士报告说她从费林制药公司、Access Fertility 和 SONA-Pharm LLC 获得咨询费，以及 Merck Serono Ltd 的资助。Harrison 博士没有利益冲突。
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