Freundl G, Godehardt E, Kern P A, Frank-Herrmann P, Koubenec H J, Gnoth Ch
Department of Reproductive Medicine and Gynaecological Endocrinology, Staedtische Kliniken Duesseldorf gGmbH, Düsseldorf, Germany.
Hum Reprod. 2003 Dec;18(12):2628-33. doi: 10.1093/humrep/deg488.
A number of menstrual cycle monitors have been developed to detect the fertile window of the menstrual cycle, mainly for contraceptive purposes. Reliable data on most of these systems are still missing but are urgently needed because many women use them and the tested systems differ enormously in price and effectiveness. We suggest a new efficacy estimating method to evaluate cycle monitors prior to full prospective clinical trials.
Sixty-two women prospectively tested seven cycle monitors and the symptothermal method (STM) of natural family planning (NFP) but not more than two different systems at the same time. The clinical fertile window was determined by detecting the day of ovulation using daily urinary LH measurements and daily ultrasonic folliculometry. This was compared to the fertile phase predicted by the systems. Maximum failure rates were estimated for each cycle monitor and the STM, using the daily conception probability rates taken from the European Fecundability Study. Intercourse was assumed to occur on each of all falsely predicted days of infertility.
Sixty-two women with a mean age of 31 years (range: 21-42 years) contributed a total of 122 cycles to this study. Monitors based on the microscopic evaluation of saliva or mucus had many more false infertile days than the other methods based on temperature or hormonal measurements (225 versus 42 days). The maximum unintended pregnancy rates per cycle for temperature computers were estimated to be 0.0134-0.0336, for the hormonal computer 0.1155 and for mini-microscopes 0.2313-0.2369. For the STM of NFP, there were no false infertile days.
The STM of NFP proved to be the most effective contraceptive method to detect the fertile window among all the methods tested. The estimated efficacy of the other cycle monitors range from the temperature computers (upper level) to the hormonal computer (medium level) and the mini-microscopes with very low estimated contraceptive efficacy.
已研发出多种月经周期监测仪，用于检测月经周期中的易孕期，主要用于避孕目的。关于这些系统的大多数可靠数据仍然缺失，但迫切需要，因为许多女性使用它们，而且所测试的系统在价格和有效性方面差异巨大。我们建议一种新的疗效评估方法，以便在全面的前瞻性临床试验之前评估周期监测仪。
62名女性前瞻性地测试了7种周期监测仪以及自然计划生育（NFP）的症状体温法（STM），但同时测试的不同系统不超过两种。通过每日测量尿促黄体生成素（LH）和每日超声卵泡监测来检测排卵日，以此确定临床易孕期。将其与各系统预测的易孕期进行比较。利用欧洲生育力研究中的每日受孕概率，估算每种周期监测仪和STM的最大失败率。假设在所有错误预测的不孕日都有性行为。
62名平均年龄为31岁（范围：21 - 42岁）的女性为本研究贡献了总共122个周期的数据。基于唾液或黏液显微镜评估的监测仪比其他基于体温或激素测量的方法有更多的错误不孕日（225天对42天）。体温计算型监测仪每个周期的最大意外妊娠率估计为0.0134 - 0.0336，激素计算型为0.1155，微型显微镜为0.2313 - 0.2369。对于NFP的STM，没有错误不孕日。
在所有测试方法中，NFP的STM被证明是检测易孕期最有效的避孕方法。其他周期监测仪的估计疗效范围从体温计算型（较高水平）到激素计算型（中等水平），而微型显微镜的估计避孕效果非常低。
