Comparison of a digital ovulation test with three popular line ovulation tests to investigate accuracy and certainty.
Expert Opin Med Diagn (2011) 5(6): 467-473.
Johnson, S. Ellis, J. Godbert, S. Ali, S. Zinaman, M.E
SPD Development Company Limited, Priory Business Park, Bedford. UK
OBJECTIVE: To determine the accuracy and certainty with which volunteers interpreted results of a digital ovulation test, Clearblue digital ovulation test (CB-DOT), compared with three home use non-digital visual ovulation tests: Clearblue ovulation test (CB-OT), First Response (FR) and Answer (AN).
METHODS : A total of 72 female volunteers aged 18-45 years interpreted test results from each of the four ovulation tests to determine the day of the luteinising hormone surge in 40 individual menstrual cycles. We used urine previously collected from 25 volunteers. The accuracy with which volunteers interpreted the test results was calculated by comparing their results with results obtained by trained technicians using a blinded test regime. For each of the four tests, volunteers were also asked to rate seven attributes of certainty and eight attributes of preference. The primary objective was to compare the accuracy with which volunteers read results from CB-DOT when compared to three visual-based line ovulation tests.
RESULTS : A significantly higher percentage of volunteers/technicians agreed on the interpretation of the results from CB-DOT (97.3%) than for CB-OT (83.5%; p=0.0153), AN (73%; p=0.0011) or FR (64.3%; p=0.0001). CB-DOT was also found to have significantly better Likert scores that CB-OT, FR and AN for all attributes of certainty and was the test that 97.2% of volunteers preferred.
CONCLUSIONS :Women can misread the results of line ovulation tests. Over 97% of volunteers correctly read the result of CB-DOT. CB-DOT was also the test that women read with most certainty and the test that most users preferred.
Mistiming of intercourse as a primary cause of failure to conceive: results of a survey on use of a home-use fertility monitor.
Curr Med Res Opin.(2007) 23:301-6.
Robinson JE, Ellis JE.
Family Health International, Research Triangle Park, NC, USA.
OBJECTIVE: To assess demographics, fecundity characteristics and fertility history of couples who successfully conceived using a home-use Fertility Monitor. Study design: This was a retrospective US observational study of couples who successfully conceived using a Fertility Monitor. Data were self-reported by volunteers using a questionnaire supplied and collected by mail. Of 276 surveys distributed, 196 (71.0%) were returned and evaluated.
RESULTS: Length of time trying to conceive was < 12 months for 70% of women; proportions were similar across age groupings. After switching to the Fertility Monitor, 49.5% and 91.9% of women had conceived within first and third cycles, respectively. Prior to Fertility Monitor use, conception aids were used by 84.2% and 64.3% had consulted a physician to seek help in attempting to conceive. Average costs of prior treatment were (in US dollars) 6637 dollars; median costs for infertility evaluation were 1075 dollars per cycle. Fertility Monitor costs ranged from 250 dollars for one cycle to 550 dollars after 10 cycles.
CONCLUSIONS: A probable cause for failure to conceive appeared to be mistiming of intercourse. The issue of early intervention with tests and medications were highlighted, resulting in escalating costs and strain on the couple. The use of a home Fertility Monitor that identifies all fertile days of the cycle and allows couples to target intercourse accordingly, should be considered as an alternative choice for couples seeking to conceive during the first year, before other attempts at infertility diagnosis are made, unless there are conflicting clinical reasons.
Increased pregnancy rate with use of the Clearblue Easy Fertility Monitor.
Fertil Steril. (2007) 87:329-34.
Robinson JEWakelin M, Ellis JE
Family Health International, Research Triangle Park, North Carolina, USA.
OBJECTIVE: To determine the effect on pregnancy rates through use of the Clearblue Easy Fertility Monitor (CEFM) in women trying to conceive.
DESIGN: Prospective study, in which volunteers were randomly assigned either to use or not to use the CEFM. All participants could also use other aids to conception. Data were self-reported by volunteers using daily diaries, supplied and collected by mail.
SETTING: Home use, under conditions normally experienced by over-the-counter purchasers of the marketed device. PATIENT(S): Women who were trying to conceive; 653 (CEFM 305, control 348) provided evaluable information.
INTERVENTION(S): CEFM was used for two cycles.
MAIN OUTCOME MEASURE(S): Cumulative pregnancy rates over two cycles of use.
RESULT(S): The cumulative pregnancy rate for 2 cycles was significantly higher in the CEFM group (22.7%) compared with the control group (14.4%). More women who had been trying to conceive for <6 months became pregnant than women who had been trying to conceive for >6 months (odds ratio: 2.67). Previous pregnancy and younger age of partners were also significant prognostic factors, but use of other aids to conception was not. After adjustment for other factors, CEFM use remained a significant factor affecting the chance of conceiving within two cycles (odds ratio: 1.89). CEFM users found the device to be easy/very easy to use (90%) and convenient/very convenient (80%).
CONCLUSION(S): Use of the CEFM increases the likelihood of getting pregnant during the first two cycles of use compared with its nonuse, in women who had been trying to conceive for up to 2 years.
Acceptability of a home monitor used to aid in conception: psychosocial factors and couple dynamics.
Contraception. 2006 Jan;73(1):65-71
Severy LJ, Robinson J, Findley-Klein C, McNulty J.
Family Health International, Research Triangle Park, NC 27709, USA. lsevery@fhi.org
BACKGROUND: Assessing the psychological acceptability of technologies designed to assist couples in achieving pregnancy is complex.
OBJECTIVE: The current study developed measures relating to the impact of one such technology on 52 couples' relationships, their feelings relating to pregnancy status and their feelings about the technology itself.
METHODS: Pregnancy status and daily logs of sexual activity were recorded for four menstrual cycles, in addition to the completion of acceptability questionnaires.
RESULTS: Baseline acceptability measures were more favorable among couples eventually achieving pregnancy. For couples not becoming pregnant, acceptability declined over time and relationships became more strained. Behavioral data clearly indicated a "targeting" and focusing of sexual activity in response to the information displayed by the monitor.
CONCLUSION: Expectations of success, couple disagreements about prior failure and partner communication patterns appear to be related to pregnancy success when using such technology.
Urinary-based ovulation and pregnancy: point-of-care testing.
Ann Pharmacother.(2004) 38:325-31.
Eichner SF, Timpe EM.
College of Pharmacy, University of Tennessee, Memphis, TN, USA. seichner@utmem.edu
OBJECTIVE: To review the literature concerning ovulation prediction devices and pregnancy detection tests for home use.
DATA SOURCES: Articles were identified through searches of the MEDLINE (1966-May 2003), EMBASE (1980-May 2003), and International Pharmaceutical Abstracts (1970-May 2003) databases using the key words ovulation, ovulation detection, pregnancy test, diagnostic reagent kit, and diagnostic test. Additional references were located through review of the bibliographies of the articles found in the literature search. Searches were not limited by time restriction, language, or use of human or animal subjects.
STUDY SELECTION AND DATA EXTRACTION: Review articles, textbook chapters, and experimental and observational studies on home use ovulation and pregnancy tests were selected.
DATA SYNTHESIS: Luteinizing hormone (LH)-based ovulation tests have demonstrated accurate and superior ovulation detection when compared to basal body temperature charting, calendar calculation, salivary ferning, or observation of vaginal or cervical discharge changes. Systems using LH and estrone-3-glucuronide (E3G) have also demonstrated accurate detection of the fertile period. Literature evaluating home use of pregnancy tests has demonstrated accurate use by lay persons.
CONCLUSIONS: Urinary-based ovulation prediction and pregnancy detection tests available for use by nonprofessionals enable women and couples to take an active role in the family planning process. Numerous products are available at reasonable costs to the consumer.
