Scientific and Medical Affairs, SPD Development Company Limited, Bedford MK44 3UP, UK.
Hum Reprod. 2013 Jan;28(1):138-51. doi: 10.1093/humrep/des372. Epub 2012 Oct 18.
Does the use of a digital home ovulation test have any effect on the level of stress in women seeking to conceive?
No difference was found in levels of stress between women using digital ovulation tests to time intercourse compared with women who were trying to conceive without any additional aids: in addition, their use did not negatively impact time to conception in users but may provide additional benefits, including an increased understanding of the menstrual cycle, reassurance and confidence in focusing conception attempts to the correct time in the cycle.
It has been suggested that timing of intercourse in such a way that it coincides with ovulation by using ovulation tests can lead to emotional distress; however, no study has been conducted to investigate this hypothesis specifically, until now.
STUDY DESIGN, SIZE AND DURATION: The study was performed over two complete menstrual cycles as a prospective, randomized, controlled trial including quantitative and qualitative methods. The intervention (test) group were given digital ovulation tests to time intercourse to the most fertile time of the cycle and the control group were provided with the current National Institute for Health and Clinical Excellence guidelines for increasing the chances of conception (intercourse every 2-3 days) and asked not to use any additional methods to time when ovulation occurs.
PARTICIPANTS/MATERIALS, SETTING AND METHODS: A total of 210 women who were seeking to conceive were recruited from the general UK population. A total of 115 women were randomized to the test group and 95 to the control group through block randomization. The positive and negative affect schedule (PANAS) and the Perceived Stress Scale (PSS) were used to measure subjective stress levels, the Short-Form 12 health survey was used as a measure of general health and well-being and urine samples were measured for biochemical markers of stress including urinary cortisol. Qualitative data were collected in the form of a telephone interview upon study completion.
There was no evidence for a difference either in total stress as measured using the PSS or in total positive or negative affect using the PANAS questionnaire between the test and control groups at any time point for the duration of the study. During cycle 1, for example, on Day 6, the difference in total stress score (test-control) was -0.62 [95% confidence interval (CI) -2.47 to 1.24] and on the day of the LH surge, it was 0.53 (95% CI -1.38 to 2.44). In addition, no correlation was observed between time trying to conceive and levels of stress, or between age and levels of stress, and no evidence was found to show that stress affected whether or not a pregnancy was achieved. There is also no evidence that the biochemistry measurements are related to whether a pregnancy was achieved or of a difference in biochemistry between the treatment groups. The use of digital ovulation tests did not negatively affect time to conception and with an adequately sized study, could potentially show improvement. To ensure that the results of this study were not affected by chance, we used a number of different methods for measuring stress, each of which had been independently validated.
Randomization occurred before the start of the study because of the need to provide the ovulation tests in readiness for Day 6 of the first cycle. As a consequence, a number of women fell pregnant during this period (22 and 13 in the test and control groups, respectively). A further 15 women were either lost to follow-up or withdrew consent prior to study start. Pregnancy rate was higher overall in the test group, so to ensure that there were sufficient data from women who failed to become pregnant in the test group, we implemented an additional biased recruitment. This second cohort may have been different from the first, although no significant differences were observed between the two phases of recruitment for any of the information collected upon admission to the study.
Women who seek medical advice while trying to conceive should not be discouraged by health care professionals from using digital ovulation tests in order to time intercourse. The cohort of women recruited to this study initially had no evidence of infertility and were looking to conceive in a non-medical setting. A separate study to assess the impact of home ovulation tests in a subfertile population would be of interest and complementary to the present study.
STUDY FUNDING/COMPETING INTERESTS: This study was funded by SPD Swiss Precision Diagnostics, GmbH, manufacturer of Clearblue(®) pregnancy and ovulation tests. SPD Development Company Ltd is a wholly owned subsidiary of SPD Swiss Precision Diagnostics GmbH; together referred to as SPD.
NCT01084304 (www.clinicaltrials.gov).
使用数字家用排卵测试对试图怀孕的女性的压力水平有何影响？
与试图怀孕但不使用任何额外辅助手段的女性相比，使用数字排卵测试来安排性交时间的女性在压力水平方面没有差异：此外，其使用并未对使用者的受孕时间产生负面影响，但可能提供了额外的益处，包括增加对月经周期的了解、对受孕尝试在周期正确时间的信心和保证。
有人认为，通过使用排卵测试来安排性交时间以使其与排卵相吻合，可能会导致情绪困扰；但是，直到现在，还没有进行研究来专门调查这一假设。
研究设计、大小和持续时间：该研究是作为一项前瞻性、随机、对照试验进行的，持续两个完整的月经周期，采用定量和定性方法。干预（测试）组使用数字排卵测试来确定最肥沃的排卵时间，对照组则提供了英国国家卫生与临床优化研究所（National Institute for Health and Clinical Excellence）增加怀孕几率的指南（每 2-3 天进行一次性交），并要求他们不要使用任何其他方法来确定排卵时间。
参与者/材料、设置和方法：从英国普通人群中招募了 210 名试图怀孕的女性。通过块随机化，将 115 名女性随机分配到测试组，95 名分配到对照组。使用积极和消极情绪量表（PANAS）和感知压力量表（PSS）来衡量主观压力水平，使用简化健康调查 12 项（Short-Form 12）作为一般健康和幸福感的衡量标准，并测量尿液中的生化应激标志物，包括尿皮质醇。在研究结束时以电话访谈的形式收集定性数据。
在研究期间的任何时间点，测试组和对照组在使用 PSS 测量的总压力或使用 PANAS 问卷测量的总积极或消极影响方面均没有证据表明存在差异。例如，在第 1 周期的第 6 天，总压力评分（测试-对照）的差异为-0.62 [95%置信区间（CI）-2.47 至 1.24]，在 LH 激增当天为 0.53（95%CI-1.38 至 2.44）。此外，没有观察到尝试怀孕的时间与压力水平之间存在相关性，也没有观察到年龄与压力水平之间存在相关性，也没有证据表明压力会影响是否怀孕。也没有证据表明生物化学测量结果与怀孕是否成功或治疗组之间的生物化学差异有关。数字排卵测试的使用并未对受孕时间产生负面影响，并且在足够大的研究中，可能会显示出改善。为了确保本研究的结果不受偶然性的影响，我们使用了多种不同的压力测量方法，每种方法都经过了独立验证。
由于需要为第 1 周期的第 6 天做好准备，因此在研究开始前就进行了随机分组。因此，一些女性在此期间怀孕（测试组和对照组分别为 22 人和 13 人）。另有 15 名女性因随访丢失或在研究开始前撤回同意而退出。测试组的总体妊娠率较高，因此为了确保测试组中未能怀孕的女性有足够的数据，我们实施了额外的有偏差的招募。这第二组可能与第一组不同，尽管在纳入研究时收集的任何信息中，两个阶段的招募之间都没有观察到显著差异。
在试图怀孕时寻求医疗建议的女性不应该因为医疗保健专业人员劝阻而不使用数字排卵测试来安排性交时间。参加这项研究的女性最初没有不孕的证据，并且希望在非医疗环境中怀孕。在亚生育人群中评估家庭排卵测试的影响的单独研究将是一项有趣的研究，并且对本研究具有补充作用。
研究资助/利益冲突：这项研究由 SPD Swiss Precision Diagnostics，GmbH 资助，该公司是 Clearblue（®）怀孕和排卵测试的制造商。SPD Development Company Ltd 是 SPD Swiss Precision Diagnostics GmbH 的全资子公司；统称为 SPD。
NCT01084304（www.clinicaltrials.gov）。
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