Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, Netherlands.
BMJ. 2010 Sep 30;341:c2501. doi: 10.1136/bmj.c2501.
To evaluate the effects of a multifaceted empowerment strategy on the actual use of single embryo transfer after in vitro fertilisation.
Randomised controlled trial.
Five in vitro fertilisation clinics in the Netherlands.
308 couples (women aged <40) on the waiting list for a first in vitro fertilisation cycle.
The multifaceted strategy aimed to empower couples in deciding how many embryos should be transferred. The strategy consisted of a decision aid, support of a nurse specialising in in vitro fertilisation, and the offer of reimbursement by way of an extra treatment cycle. The control group received standard care for in vitro fertilisation.
Use of single embryo transfer in the first and second treatment cycles as well as decision making variables and costs of the empowerment strategy.
After the first treatment cycle, single embryo transfer was used by 43% (65/152) of couples in the intervention group and 32% (50/156) in the control group (difference 11%, 95% confidence interval 0% to 22%; P=0.05). After the second treatment cycle, single embryo transfer was used by 26% (14/154) of couples in the intervention group compared with 16% (8/51) in the control group (difference 10%, -6% to 26%; P=0.20). Compared with couples receiving standard care, those receiving the empowerment strategy had significantly higher empowerment and knowledge levels but no differences in anxiety levels. Mean total savings per couple in the intervention group were calculated to be €169.75 (£146.77; $219.12).
A multifaceted empowerment strategy encouraged use of single embryo transfer, increased patients' knowledge, reduced costs, and had no effect on levels of anxiety or depression. This strategy could therefore be an important tool to reduce the twin pregnancy rate after in vitro fertilisation. This trial did not, however, demonstrate the anticipated 25% difference in use of single embryo transfer of the power calculation.
ClinicalTrials.gov NCT00315029.
评估多方面赋能策略对体外受精后实际使用单胚胎移植的影响。
随机对照试验。
荷兰的 5 家体外受精诊所。
308 对等待首次体外受精周期的夫妇（<40 岁的女性）。
多方面策略旨在使夫妇能够在决定应移植多少个胚胎方面更有决策权。该策略包括决策辅助工具、一名专门从事体外受精的护士的支持，以及通过额外的治疗周期提供报销。对照组接受常规体外受精护理。
首次和第二次治疗周期中单胚胎移植的使用情况，以及决策变量和赋能策略的成本。
在第一个治疗周期后，干预组中 43%（65/152）的夫妇使用了单胚胎移植，而对照组中 32%（50/156）的夫妇使用了单胚胎移植（差异 11%，95%置信区间 0%至 22%；P=0.05）。在第二个治疗周期后，干预组中有 26%（14/154）的夫妇使用了单胚胎移植，而对照组中有 16%（8/51）的夫妇使用了单胚胎移植（差异 10%，-6%至 26%；P=0.20）。与接受标准护理的夫妇相比，接受赋能策略的夫妇的赋能和知识水平显著提高，但焦虑水平没有差异。干预组中每对夫妇的平均总节省额计算为 169.75 欧元（146.77 英镑；219.12 美元）。
多方面赋能策略鼓励使用单胚胎移植，提高了患者的知识水平，降低了成本，且对焦虑或抑郁水平没有影响。因此，这种策略可能是降低体外受精后双胞胎妊娠率的重要工具。然而，本试验并未显示出预期的 25%的单胚胎移植使用差异，这与功效计算的预期结果不符。
ClinicalTrials.gov NCT00315029。
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