Live birth is the correct outcome for clinical trials evaluating therapy for the infertile couple.
Live birth is the correct outcome for clinical trials evaluating therapy for the infertile couple.
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DOI:
10.1016/j.fertnstert.2014.03.026
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发表时间:
2014-05
影响因子:
6.7
通讯作者:
Barnhart KT
中科院分区:
文献类型:
--
作者:
Barnhart KT
Well-designed and conducted clinical trials are needed to further advance the field for reproductive medicine. However current reporting of outcomes of trials is ambiguous and disparate. In this manuscript it is offed that the preferred outcome for clinical trials in reproductive medicine should be live birth. Multiple births should be listed and it should be specified whether this is multiple births per couple or multiple births per conception. The unit of measure should be women (or couples) and not cycles. The duration of exposure should also be clearly identified (i.e., treatment was one cycle, a pre-specified number of cycles, or a period of time). Pregnancy loss should be specified and the denominator should be those who conceived. While live birth is the primary outcome, complications should be defined and reported including multiple births and other objective markers such as preterm delivery, small-for-gestational age, or stillbirth.
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