Comparison of analytical sensitivity and women’s interpretation of home pregnancy tests

Johnson, Sarah; Cushion, Michael G.; Bond, Sharon; Godbert, Sonya; Pike, Joanna

doi:10.1515/cclm-2014-0643

Cited by 33 publications

(23 citation statements)

References 3 publications

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“…Our use of fertility monitors enabled us to accurately estimate conception using ovulation as its proxy, and use of digital pregnancy tests with demonstrated validity and user accuracy (16). We also were able to quantify small but highly significant (P ≤0.001) reductions in women’s daily mean number of cigarettes smoked (−0.15) or alcoholic (−0.34) and caffeinated (−0.51) beverages consumed between the preconception and early pregnancy sensitive windows, underscoring the need for continual guidance aimed at promoting healthy behaviors.…”

Section: Discussionmentioning

confidence: 99%

“…In comparison to the gold standard of ultrasonography for the detection of ovulation, the monitor is reported to accurately detect the LH surge (99%) (15). Women also were trained in the use of the Clearblue® digital pregnancy test, which has demonstrated sensitivity and reliability for detecting 25 mIU/mL of hCG, and demonstrated accuracy by women (16). Women tested their urine for pregnancy on the day they expected menstruation consistent with manufacturer’s guidance.…”

Section: Methodsmentioning

confidence: 99%

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Lifestyle and pregnancy loss in a contemporary cohort of women recruited before conception: The LIFE Study

Louis

Sapra

Schisterman

et al. 2016

Fertility and Sterility

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Objective To estimate pregnancy loss incidence in a contemporary cohort of couples whose lifestyles were measured during sensitive windows of reproduction to identify factors associated with pregnancy loss for the continual refinement of preconception guidance. Design Prospective cohort with preconception enrollment. Setting 16 counties in Michigan and Texas. Patients 344 couples with a singleton pregnancy followed daily through 7 post-conception weeks of gestation. Interventions None. Daily, couples recorded use of cigarettes, caffeinated and alcoholic beverages, and multivitamins. Women used fertility “monitors” for ovulation detection and digital pregnancy tests. Pregnancy loss was denoted by conversion to a negative pregnancy test, onset of menses or clinical confirmation depending upon gestation. Using proportional hazards regression and accounting for right censoring, we estimated adjusted hazard ratios and 95% confidence intervals (aHR; 95% CI) for couples’ lifestyles (cigarette smoking, alcoholic and caffeinated drinks, multivitamins) during three sensitive windows: preconception, early pregnancy and periconception. Main outcomes measured Incidence and risk factors for pregnancy loss. Results 98/344 (28%) women with a singleton pregnancy experienced an observed pregnancy loss. In the preconception window, loss was associated with female age ≥35 years (1.96; 1.13-3.38) accounting for couples’ ages, female and male consumption >2 daily caffeinated beverages (1.74; 1.07-2.81 and 1.73; 1.10-2.72, respectively), and females’ vitamin adherence (0.45; 0.25-0.80). The findings were similar for lifestyle during the early pregnancy and periconception windows. Conclusions Couples’ preconception lifestyle factors were associated with pregnancy loss, though women’s multivitamin adherence dramatically reduced risk. The findings support continual refinement and implementation of preconception guidance.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Lifestyle and pregnancy loss in a contemporary cohort of women recruited before conception: The LIFE Study

Louis

Sapra

Schisterman

et al. 2016

Fertility and Sterility

View full text Add to dashboard Cite

show abstract

“…There are important study strengths that underlie these findings including our population‐based sampling approach that did not rely on men seeking clinical care, a high percent of men providing semen samples, in‐depth semen analysis of 35 endpoints, well measured risk factors, and prospectively measured time‐to‐pregnancy using home pregnancy test kits with demonstrated sensitivity for detecting 25 mIU/mL of human chorionic gonadotropin (hCG) and accurately used by women (Johnson et al ., 2015). Still, important limitations need to be considered including our reliance on 24‐h motility measures in light of at home semen collection, the potential for chance findings and residual confounding given the study's observational design.…”

Section: Discussionmentioning

confidence: 99%

A data‐driven search for semen‐related phenotypes in conception delay

2016

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SummarySperm count, morphology, and motility have been reported to be predictive of pregnancy, although with equivocal basis prompting some authors to question the prognostic value of semen analysis. To assess the utility of including semen quality data in predicting conception delay or requiring >6 cycles to become pregnant (referred to as conception delay), we utilized novel data‐driven analytic techniques in a pre‐conception cohort of couples prospectively followed up for time‐to‐pregnancy. The study cohort comprised 402 (80%) male partners who provided semen samples and had time‐to‐pregnancy information. Female partners used home pregnancy tests and recorded results in daily journals. Odds ratios (OR), false discovery rates, and 95% confidence intervals (CIs) for conception delay (time‐to‐pregnancy > 6 cycles) were estimated for 40 semen quality phenotypes comprising 35 semen quality endpoints and 5 closely related fecundity determinants (body mass index, time of contraception, lipids, cotinine and seminal white blood cells). Both traditional and strict sperm phenotype measures were associated with lower odds of conception delay. Specifically, for an increase in percent morphologically normal spermatozoa using traditional methods, we observed a 40% decrease in conception delay (OR = 0.6, 95% CI = 0.50, 0.81; p = 0.0003). Similarly, for an increase in strict criteria, we observed a 30% decrease in odds for conception delay (OR = 0.7, 95% CI = 0.52, 0.83; p = 0.001). On the other hand, an increase in percent coiled tail spermatozoa was associated with a 40% increase in the odds for conception delay (OR = 1.4, 95% CI = 1.12, 1.75; p = 0.003). However, our findings suggest that semen phenotypes have little predictive value of conception delay (area under the curve of 73%). In a multivariate model containing significant semen factors and traditional risk factors (i.e. age, body mass index, cotinine and ever having fathered a pregnancy), there was a modest improvement in prediction of conception delay (16% increase in area under the curve, p < 0.0002).

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“…As highlighted by Johnson et al in this issue of the journal, there is a need for internationally standardized methods for expressing the performance of HPTs [8]. Many countries have no national standards that address this issue and among those that do, such as the US, such guidance may be outdated and inadequate [9].…”

mentioning

confidence: 99%

“…It is hoped that the work of Johnson et al [8] gains the attention of HPT manufacturers. Consumers of these devices often lack an appreciation of the strengths and limitations of qualitative hCG screening tests and will rely heavily on marketing claims to guide their purchasing decisions.…”

mentioning

confidence: 99%

Variable accuracy of home pregnancy tests: truth in advertising?

Grenache¹

2015

Clinical Chemistry and Laboratory Medicine (CCLM)

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Comparison of analytical sensitivity and women’s interpretation of home pregnancy tests

Abstract: Many home-based pregnancy tests commonly used by women are not as accurate as their packaging information claims. International test standards which define appropriate performance characteristics for home pregnancy tests are urgently required.

Cited by 33 publications

References 3 publications

Lifestyle and pregnancy loss in a contemporary cohort of women recruited before conception: The LIFE Study

Lifestyle and pregnancy loss in a contemporary cohort of women recruited before conception: The LIFE Study

A data‐driven search for semen‐related phenotypes in conception delay

Variable accuracy of home pregnancy tests: truth in advertising?

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