Institute of Fundamental Sciences, Massey University, Palmerston North, New Zealand.
Hum Reprod. 2013 Dec;28(12):3306-15. doi: 10.1093/humrep/det389. Epub 2013 Oct 29.
What are the characteristics of, and how variable are, individual normal menstrual cycle profiles of excretion rates for the urinary metabolites oestrone glucuronide (E1G) and pregnanediol glucuronide (PdG)?
There is a continuum of menstrual cycle profiles that differ from standard textbook profiles but which can be understood simply in terms of growth, atresia and ovulation of ovarian follicles.
Point-of-care assays with the Ovarian Monitor pre-coated assay tubes, using urine samples diluted to a constant volume per unit time, give laboratory accurate clinical data for individual menstrual cycles. Lay operators can perform the point-of-care assay system at home to achieve reliable and reproducible results, which can be used for natural family planning.
STUDY DESIGN, SIZE, DURATION: This prospective study involved 62 women, with normal menstrual cycles, recruited from three centres: Palmerston North, New Zealand, Sydney, Australia and Santiago, Chile. The study lasted 3 years.
PARTICIPANTS/MATERIALS, SETTING, METHODS: Women collected daily urine samples and determined their E1G and PdG rates with a pre-coated enzyme assay system known as the Ovarian Monitor. For two cycles, the assays were repeated in a study centre and the results were averaged to give 113 individual menstrual cycles for analysis. The cycles were displayed individually in a proprietary database program.
The individual normal hormonal profiles were more complex than the classic composite curves for 40% of the cycles. Of 113 ostensibly normal cycles, only 91 were potentially fertile and 22 had some luteal phase defect. The oestrone glucuronide and PdG excretion rates were reliable and informative in the non-invasive elucidation of ovulation and ovarian function for both simple and complex profiles. Daily monitoring revealed the variability of normal menstrual cycle profiles. The LH peaks were variable and ambiguous markers for ovulation.
LIMITATIONS, REASONS FOR CAUTION: The study consisted of cycles only from women with regular cycles of 20-40 days duration. All the women were intending to avoid a pregnancy during the study thus the limits of the fertile window were not tested.
The principles established in this study should apply to cycles of any length. All peaks in oestrone glucuronide excretion should be tested by concurrent measurements of PdG, which gives a positive indication of the fate of the follicle it represents. The Ovarian Monitor provides a useful addition for practitioners of natural family planning.
STUDY FUNDING/COMPETING INTEREST(S): Financial support for this study was obtained from the UNDP/UNFPA/World Bank/WHO Special Programme of Research, Development and Research Training in Human Reproduction (HRP). D.G.C. is currently employed by and holds stock in Manawatu Diagnostics Ltd, a company in the development phase of a potentially competing product. The remaining authors have nothing to declare.
个体正常月经周期中尿代谢产物雌酮葡萄糖醛酸（E1G）和孕二醇葡萄糖醛酸（PdG）排泄率的特征是什么，其变化如何？
存在着一系列与标准教科书模式不同的月经周期模式，但可以简单地理解为卵巢卵泡的生长、闭锁和排卵。
使用预包被酶测定系统卵巢监测仪，以单位时间恒定体积稀释尿液样本，可提供个体月经周期的实验室准确临床数据。非专业操作人员可以在家中进行即时检测系统，以获得可靠和可重复的结果，可用于自然计划生育。
研究设计、大小、持续时间：这项前瞻性研究涉及来自三个中心（新西兰的北帕默斯顿、澳大利亚的悉尼和智利的圣地亚哥）的 62 名正常月经周期的女性。研究持续了 3 年。
参与者/材料、地点、方法：女性每天采集尿液样本，并使用预包被的酶测定系统卵巢监测仪测定 E1G 和 PdG 率。在两个周期中，在研究中心重复进行测定，并将结果平均化，得出 113 个单独的月经周期进行分析。这些周期在一个专有的数据库程序中单独显示。
113 个看似正常的周期中，只有 91 个周期可能具有生育能力，22 个周期存在黄体期缺陷。雌酮葡萄糖醛酸和 PdG 排泄率在非侵入性阐明排卵和卵巢功能方面是可靠和有信息的，无论是简单还是复杂的模式。每日监测揭示了正常月经周期模式的可变性。LH 峰值是排卵的可变且模糊的标志物。
局限性、谨慎的原因：该研究仅包括周期为 20-40 天的女性的正常周期。所有女性都打算在研究期间避免怀孕，因此未测试生育窗口的极限。
本研究中确立的原则应适用于任何长度的周期。所有雌酮葡萄糖醛酸排泄峰值都应通过 PdG 的同步测量进行测试，这表明它代表的卵泡的命运。卵巢监测仪为自然计划生育的从业者提供了有用的补充。
研究资金/竞争利益：这项研究得到了联合国开发计划署/联合国人口基金/世界银行/世界卫生组织人类生殖研究、发展和研究培训特别方案（HRP）的资助。D.G.C. 目前受雇于 Manawatu Diagnostics Ltd，这是一家处于潜在竞争产品开发阶段的公司，并持有该公司的股份。其余作者没有任何声明。
