Home ovulation test use and stress during subfertility evaluation: Subarm of a randomized controlled trial

Sarah Weddell, Georgina L Jones, Sheila Duffy, Cameron Hogg, Sarah Johnson, William Ledger, Sarah Weddell, Georgina L Jones, Sheila Duffy, Cameron Hogg, Sarah Johnson, William Ledger

Abstract

Objectives: A prospective, randomized controlled trial in women seeking to conceive examined the impact of using ovulation tests on self-reported levels of stress, psychological well-being, and quality of life in women with unexplained infertility.

Method: The test group used a home ovulation test to detect the day of ovulation, whereas the control group were provided with a predicted day of ovulation based on the average length of menstrual cycle reported during study recruitment. Volunteers collected their first morning urine samples to evaluate biochemical levels of stress (urinary cortisol and estrone-3-glucouronide) and completed questionnaires over two complete menstrual cycles.

Results: Overall, the use of digital ovulation tests by sub-fertile women under medical care had negligible negative effects and no detectable positive benefit on psychological well-being, according to multiple measurements of stress by questionnaire and biochemical markers. No significant differences were found between groups for all stress measures at the various study time points, except in relation to "couple concordance" where the test group scored much higher than the control group (mean difference at end of study was 21.25 (95% confidence interval: 9.25, 33.25; P = 0.0015)). The maximum difference in log cortisol: creatinine ratio between the test and control groups was -0.28 (95% confidence interval: -0.69, 0.13).

Conclusions: These results do not support propositions that using digital ovulation tests can cause stress in women trying to conceive.

Keywords: cortisol; infertility; ovulation tests; questionnaire; stress; timed intercourse.

Conflict of interest statement

Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: S.W., C.H., and S.J. are employees of SPD Swiss Precision Diagnostics Development Company Limited, which provided funding for this study. S.D. has no conflict of interest to declare. G.L.J. has received a grant from SPD Swiss Precision Diagnostics Development Company Limited. W.L. is a Board Member of the Royal Hospital for Women Foundation and Flinders Fertility, he receives research support from Ferring Pharmaceuticals, Merck, and Swiss Precision Diagnostics, and is a minority share-holder in Virtus Health.

Figures

Figure 1.
Figure 1.
Assessment schedule of study protocol. EHIQ: Emotional Health in Infertility Questionnaire; PANAS: Positive and Negative Affect Schedule; PSS: Perceived Stress Scale; SF-12v2: Short Form-12 Health Survey version 2; T: time point. Day 6 of menstrual cycle relative to the first day of menstrual bleeding.
Figure 2.
Figure 2.
Schedule of events and numbers of volunteers at each time point during the study. The 50 volunteers were equally randomized into two groups; however, there was unequal loss of volunteers between groups for the duration of the study. “Pre-cycle 1 pregnancies” indicates that pregnancy occurred post-randomization but before their first study cycle was due to begin. WC: withdrawn consent; LTF: lost to follow-up.
Figure 3.
Figure 3.
Graphical representations of total stress scores as measured using the Perceived Stress Scale questionnaire: (a) The mean difference in total stress scores comparing test group with control group and (b) the median, 5th and 95th percentile changes in stress score since baseline by randomization group.
Figure 4.
Figure 4.
Graphical representations of positive-affect scores as measured by the positive domains of the PANAS: (a) The mean difference in positive-affect scores comparing test group with control group and (b) the median, 5th and 95th percentile changes in positive-affect score since baseline by randomization group. PANAS: Positive and Negative Affect Schedule.
Figure 5.
Figure 5.
Graphical representations of negative-affect scores as measured by the negative domains of the PANAS: (a) The mean difference in negative-affect scores comparing test group and control group and (b) the median, 5th and 95th percentile changes in negative-affect score since baseline by randomization group. PANAS: Positive and Negative Affect Schedule.
Figure 6.
Figure 6.
Graphical representations of biochemical marker data: (a) The mean difference in log cortisol: creatinine ratio scores comparing test group with control group and (b) the mean difference in log E3G: creatinine ratio scores comparing test group with control group. E3G: estrone-3-glucoronide.

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