Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.
Best Pract Res Clin Endocrinol Metab. 2019 Feb;33(1):3-8. doi: 10.1016/j.beem.2019.01.004. Epub 2019 Jan 25.
Since the first successful treatment with conventional in vitro fertilization (IVF) in 1978 assisted reproductive technology (ART) has become an integral part of modern medicine and now plays a key role in the fulfillment of family planning. At least five million of infants have been born as a result of ART and in some countries the proportion of infants born after ART now exceeds 5%. Such an impact of ART on society and demography call for adequate surveillance including vigilance of occurring adverse events, especially when novel technology is introduced. In many countries the activities in ART are being recorded and analyzed by national registries, either on a voluntary or on a compulsory basis. Despite all endeavour, the data sets are still incomplete and complications are underreported. In addition, the published reports usually contain cross-sectional data only, collected and analyzed on an annual basis. However, current ART is now developing towards a segmented longitudinal approach, in which single therapeutic steps may be spread over prolonged time intervals. In the near future, ART-data should be handled and reported in a cumulative fashion. The final outcome of ART, defined by the birth of a healthy baby or by the final consumption or destruction of cells and tissues, must be made traceable to one single initiating event, such as the first day of ovarian stimulation or the collection of oocytes, even if that event took place several years earlier. In failed cases or when frozen material was lost or destroyed or transported, negative outcome events should be recorded in order to avoid overestimation of treatment efficacy. To all stakeholders, both surveillance and vigilance in ART are crucial steps towards better quality control and full transparency.
自 1978 年首例常规体外受精（IVF）成功治疗以来，辅助生殖技术（ART）已成为现代医学的重要组成部分，目前在计划生育中发挥着关键作用。至少有 500 万名婴儿是通过 ART 出生的，在一些国家，通过 ART 出生的婴儿比例现在已经超过 5%。ART 对社会和人口统计学的影响要求进行充分的监测，包括对发生的不良事件保持警惕，尤其是在引入新技术时。在许多国家，ART 的活动都由国家登记处记录和分析，无论是自愿的还是强制的。尽管做出了所有努力，数据集仍然不完整，并发症报告不足。此外，公布的报告通常只包含横断面数据，每年收集和分析一次。然而，目前的 ART 现在正在朝着分段纵向方法发展，其中单个治疗步骤可能会在很长的时间间隔内进行。在不久的将来，ART 数据应该以累积的方式进行处理和报告。ART 的最终结果，即健康婴儿的出生，或细胞和组织的最终消耗或破坏，必须能够追溯到单个起始事件，例如卵巢刺激的第一天或卵母细胞的采集，即使该事件发生在几年前。在失败的情况下，或者当冷冻材料丢失、销毁或运输时，应记录负面结果事件，以避免高估治疗效果。对于所有利益相关者来说，ART 中的监测和警惕都是实现更好的质量控制和完全透明的关键步骤。
