Erratum to 'The postcoital test in the development of new vaginal contraceptives'.
Erratum to 'The postcoital test in the development of new vaginal contraceptives'.
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DOI：
10.1093/biolre/ioaa148
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发表时间：
2020-10-05
影响因子：
3.6
通讯作者：
Vincent KL
中科院分区：
文献类型：
--
作者：
Mauck CK;Vincent KL
性交后测试 (PCT) 已在不孕夫妇的临床评估中使用了一个多世纪，在新阴道避孕产品的评估中也使用了近 70 年。在不孕症研究中，PCT 已很大程度上被更现代的方法所取代，但它们仍然是获得阴道避孕产品有效性初步数据的最有用方法。世界卫生组织描述了该程序的重要方面。它涉及在性交后的某个时间点收集宫颈粘液，并对粘液中发现的精子进行计数和表征。在不孕症研究中，多种渐进运动精子（PMS）与怀孕率相关。避孕试验的资格包括要求夫妇在没有测试产品的情况下，在基线周期的中期，每个高功率场的 PMS 达到一定的阈值数量。主要终点或测试周期中令人满意的结果的定义是预先定义的。文献综述确定了 10 项阴道避孕药 PCT 研究，涉及 9 种测试产品。迄今为止，在任何阴道避孕药的开发中，阴道避孕药的 II 期试验尚未被认为是可行的。对测试产品的 PCT 研究可以预测避孕效果，尽管最终的避孕效果受到产品的易用性以及患者依从性的影响。 PCT 结果与后来在功效试验中表现出令人满意的性能的产品相似，是测试产品可能成功的最佳指标。
Postcoital tests (PCTs) have been used for over a century in the clinical evaluation of infertile couples, and for nearly 70 years in the evaluation of new vaginal contraceptive products. PCTs have been largely replaced by more modern methods in the study of infertility, but they remain the most useful way to obtain preliminary data on the effectiveness of vaginal contraceptive products. The World Health Organization has described important aspects of the procedure. It involves collection of cervical mucus at a certain time point after intercourse and the counting and characterization of sperm found in the mucus. A wide range of progressively motile sperm (PMS) has been associated with pregnancy rates in infertility studies. Eligibility for contraceptive trials includes the requirement that couples achieve a certain threshold number of PMS per high power field at midcycle in a baseline cycle without the test product. The primary endpoint, or definition of a satisfactory result in test cycles, is predefined. A literature review identified 10 PCT studies of vaginal contraceptives involving nine test products. Phase II trials of vaginal contraceptives have not been deemed feasible in the development of any vaginal contraceptive to date. A PCT study of a test product can be predictive of contraceptive efficacy, although ultimate contraceptive effectiveness is influenced by the ease of use of the product, along with patient compliance. PCT results similar to results seen with products that later showed satisfactory performance in efficacy trials is the best indicator of likely success of a test product.
影响因子：
3.6
作者：
Mauck, Christine K.;Vincent, Kathleen L.
通讯作者：
Vincent, Kathleen L.