The postcoital test in the development of new vaginal contraceptives
The postcoital test in the development of new vaginal contraceptives
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DOI：
10.1093/biolre/ioaa099
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发表时间：
2020-08-01
影响因子：
3.6
通讯作者：
Vincent, Kathleen L.
中科院分区：
文献类型：
--
作者：
Mauck, Christine K.;Vincent, Kathleen L.
性交后测试(PCT)用于不孕夫妇的临床评估已有一个多世纪的历史，用于评估新的阴道避孕产品已有近70年的历史。在不孕症的研究中，PCT在很大程度上已经被更现代的方法所取代，但它们仍然是获得关于阴道避孕药有效性的初步数据的最有用的方法。世界卫生组织描述了该程序的重要方面。它包括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鉴定。在不孕症研究中，广泛的渐进性活动精子(PMS)与妊娠率有关。避孕试验的资格包括要求夫妇在没有测试产品的情况下，在基线周期的中期达到每高功率领域一定门槛的经前综合症数量。主要终点或测试周期中满意结果的定义是预定义的。一篇文献综述确定了10项关于阴道避孕药的PCT研究，涉及9种测试产品。到目前为止，阴道避孕药的第二阶段试验在任何阴道避孕药的开发中都不被认为是可行的。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该产品的易用性以及患者依从性的影响。PCT结果类似于后来在疗效试验中表现出令人满意的产品的结果，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.