A New Website for Australian IVF Patients 'Evidence-based IVF': an Online Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,217
- 试验地点
- 2
- 主要终点
- Gist comprehension using bespoke 5-item questionnaire
研究概览
简要总结
IVF 'add-ons' are extra procedures, techniques, or medicines offered alongside standard IVF treatments, often marketed to improve success rates. Examples include EmbryoGlue, endometrial scratching, and acupuncture. However, most lack clear evidence of effectiveness or safety. Despite this, over 80% of Australian IVF patients use add-ons, sometimes paying thousands of dollars.
Patients often rely on clinic websites and online forums for information, but these sources frequently exaggerate benefits while omitting information about costs and risks. There is no independent, evidence-based resource in Australia to guide decision-making, a gap recognized by both patients and government reports.
To address this, the investigators developed "Evidence-Based IVF (EBI)," a new website informed by patient decision aid standards, expertise in digital health and risk communication, and co-design sessions with IVF patients and professionals. The investigators now plan to evaluate how well it helps patients understand the evidence base for IVF add-ons.
详细描述
In response to widespread calls for evidence-based resources about IVF options and add-ons in Australia, the investigators assembled a multidisciplinary team to co-design a novel website prototype referred to as 'Evidence-based IVF (EBI)'. Informed by patient decision aids standards, the MAGIC App, and applying the investigators' expertise in digital and risk communication and evidence-informed health decisions, the investigators undertook interviews with Australian IVF patients and professionals to test and iteratively modify a new resource. This trial will evaluate how this website performs in terms of gist knowledge and acceptability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Live in Australia
- •Undergone IVF/embryo transfer in the last 2 years or planning IVF/embryo transfer in the next six months. IVF refers to any IVF/ICSI/embryo transfer cycle in which the participant or their partner is planning to get pregnant.
排除标准
- •People who underwent IVF process for egg-freezing or embryo freezing and not intending to conceive, or who received an embryo transfer as a surrogate.
结局指标
主要结局
Gist comprehension using bespoke 5-item questionnaire
时间窗: 24 hours
5-item measure, correct answer = 2 points per item, max of 10 points, higher score means better comprehension Items 1-3. How does \[EmbryoGlue/Intralipid/ERA test\] affect the chance of \[getting pregnant/having a baby/having a miscarriage\] from IVF? * Increases the chance * Possibly increases the chance * Has no effect on the chance * Possibly decreases the chance * Decreases the chance * Its unclear * I don't know 4. The scientific studies of \[EmbryoGlue/Intralipid/ERA test\] are * High quality and very reliable * Moderate quality and reliable * Low quality and somewhat reliable * Very low quality and not at all reliable * I don't know 5. \[EmbryoGlue/Intralipid/ERA test\] is associated with the following risks * Headache * Infection * Pain or discomfort * Nausea and vomiting * Fever or chills * Hair loss Developed from Smith 2012
次要结局
- Proportion of participants with correct comprehension of magnitude of effect(24 hours)
- Proportion of participants with correct understanding of populations IVF add-on is applicable to(24 hours)
- Proportion of participants with correct comprehension of cost of IVF add-on(24 hours)
- Information satisfaction(24 hours)
- Emotional response(24 hours)
- Hypothetical willingness to speak to IVF specialist about using the add-on(24 hours)
- Self-assessed comprehension(24 hours)
- Information length(24 hours)
- Recommend this information(24 hours)
研究者
Sarah Lensen
Senior Research Fellow, Principal Investigator
University of Melbourne