Oncology and Metabolism, The University of Sheffield, Sheffield, UK
Obstetrics and Gynaecology, The University of Melbourne, Melbourne, Victoria, Australia.
BMJ Open. 2021 May 21;11(5):e047307. doi: 10.1136/bmjopen-2020-047307.
For couples undergoing assisted reproduction, a plethora of adjuncts are available; these are known as 'add-ons'. Most add-ons are not supported by good quality randomised trial evidence of efficacy, with some proven to be ineffective. However, estimates suggest that over 70% of fertility clinics provide at least one add-on, often at extra cost to the patient. This study has three aims. First, to undertake a survey of in vitro fertilisation (IVF) clinics in the UK to ascertain which add-ons are being offered and at what cost. Second, to undertake qualitative semi-structured interviews of patients, clinicians and embryologists, to explore their opinions and beliefs surrounding add-ons. Third, to review the interpretation of the Human Fertilisation and Embryology Authority traffic light system, to better understand the information required by IVF patients, clinicians and embryologists when making decisions about add-ons.
All UK IVF clinics will be contacted by email and invited to complete an online survey. The survey will ask them which add-ons they offer, at what cost per cycle and how information is shared with patients. Semi-structured interviews will be conducted in the UK and Australia with three groups of participants: (i) fertility patients; (ii) clinicians and (iii) embryologists. Participants for the interviews will be recruited via social media channels, website adverts, email and snowball sampling. Up to 20 participants will be recruited for each group in each country. Following an online consent process, interviews will be conducted via video-conferencing software, transcribed verbatim and data subjected to inductive thematic analysis.
Ethical approval has been granted by the Universities of Sheffield, Bath Spa and Melbourne. Findings will be published in a peer-reviewed journal and disseminated to regulatory bodies in the UK and Australia. A lay summary of findings will be shared via Fertility Network, UK.
对于接受辅助生殖的夫妇来说，有很多辅助手段可用；这些被称为“附加物”。大多数附加物都没有高质量的随机试验证据支持其疗效，其中一些已被证明无效。然而，估计有超过 70%的生育诊所提供至少一种附加物，通常会给患者增加额外的费用。本研究有三个目的。首先，对英国的体外受精 (IVF) 诊所进行调查，以确定提供哪些附加物以及费用是多少。其次，对患者、临床医生和胚胎学家进行定性半结构化访谈，探讨他们对附加物的看法和信念。第三，审查人类受精和胚胎学管理局红绿灯系统的解释，以更好地了解 IVF 患者、临床医生和胚胎学家在决定附加物时所需的信息。
将通过电子邮件联系所有英国 IVF 诊所，并邀请他们填写在线调查。该调查将询问他们提供哪些附加物、每个周期的费用是多少以及如何与患者分享信息。将在英国和澳大利亚进行半结构化访谈，参与者分为三组：(i) 生育患者；(ii) 临床医生和 (iii) 胚胎学家。将通过社交媒体渠道、网站广告、电子邮件和滚雪球抽样招募参与者参加访谈。每个国家/地区每个组将招募多达 20 名参与者。在完成在线同意程序后，将通过视频会议软件进行访谈，逐字记录，并对数据进行归纳主题分析。
谢菲尔德大学、巴斯斯巴大学和墨尔本大学已批准伦理。研究结果将发表在同行评议的期刊上，并分发给英国和澳大利亚的监管机构。将通过英国生育网络分享调查结果的通俗摘要。
