The Clearblue Digital Pregnancy Test with Conception Indicator is:

Accurate -  over 99% accurate in detecting pregnancy from the day the period is due Unique -  the ONLY pregnancy test that can estimate time since conception Clinically proven -  correlates with estimation of gestational aging by routine ultrasound Sensitive - can be used up to 4 days before the period is due Unmistakably clear -  results displayed in words and numbers on a digital screen Reliable -  based on established technology Simple to use -  convenient and easy to interpret Trustworthy -  from Clearblue, the worlds leading brand in home pregnancy and fertility testing

Clearblue Digital Pregnancy Test with Conception Indicator

The only pregnancy test that can estimate time since conception

For more information about the Clearblue Digital Pregnancy Test with Conception Indicator, please visit our websites:

www.clearblue.com www.swissprecisiondiagnostics.com

SPD Swiss Precision Diagnostics GmbH, 1213 Petit Lancy, Geneva, Switzerland
2011 SPD Swiss Precision Diagnostics GmbH. All rights reserved. Clearblue is a trade mark Clearblue Professional Series: ROW-CI v1.0 April 2011

Clearblue Professional Series

Contents
Revolutionising Home Pregnancy Testing Innovation Using Established Technology Solid Clinical Foundations Thorough Scientific Basis State-of-The-Art Micro-Semiquantitation User-friendly and Convenient Boasts a Wealth of Clinical Evidence Reliable in Detecting Pregnancy 4 5 6 8 9 11 12 13 14 15 16 17 18 18 19 20 21 22

About Clearblue
Clearblue is the worlds leading brand in home pregnancy and fertility testing. Consumers trust the Clearblue brand because it delivers the accurate information they want. The Clearblue product range is built on a strong foundation of peerreviewed science and consumer understanding. Clearblue products are also trusted and recommended by doctors, many of whom recognise that Clearblue is supported by 25 years of expertise, quality, and innovation in consumer diagnostics.

Highly Sensitive for Pregnancy Detection Before the Day the Period is Due Accurate in Determining Time since Conception Excellent Pregnancy Duration Agreement with Standard-of-Care Ultrasound Conception Result Simple to Interpret Easy to Use Trusted by Women The Test Women Most Favour Meets the Needs of Healthcare Professionals About SPD Swiss Precision Diagnostics GmbH References

Revolutionising home pregnancy testing

Clearblue Digital Pregnancy Test with Conception Indicator is the latest innovation in pregnancy testing. This simple to use product is unique in that not only does it inform a woman whether she is pregnant or not, but also indicates when she conceived. The test is >99% accurate in detecting pregnancy and 92% accurate in estimating time since conception.
 The Clearblue Digital Pregnancy Test with Conception Indicator combines all the benefits of the current Clearblue one-step digital pregnancy test with the unique advantage of a Conception Indicator feature Pregnancy is detected with >99% accuracy when testing from the day the period is due  The overall accuracy of the Clearblue Digital Pregnancy Test with Conception Indicator was 92% in  estimating time since conception. This feature uses known levels of human Chorionic Gonadotropin (hCG) in urine relative to the day of the luteinising hormone (LH) surge +1 day, to estimate time since conception The accuracy of Clearblue Digital Pregnancy Test with Conception Indicator in estimating time since  conception (and therefore gestational aging) has been further validated by comparison with standard-ofcare ultrasound gestational aging and the results of both methods found to be 98% in agreement Discovering when conception took place may assist in planning for the pregnancy The Clearblue Digital Pregnancy Test with Conception Indicator has been developed by SPD Swiss Precision  Diagnostics GmbH (SPD), pioneers of the worlds first one-step and digital pregnancy tests and leaders in womens health consumer diagnostics Clearblue has been working closely with consumers and healthcare professionals for over 25 years to  deliver trusted, quality products in pregnancy and fertility

Innovation using established technology

 As with other home pregnancy tests, the Clearblue Digital Pregnancy Test with Conception Indicator detects and measures hCG, the hormone produced early in pregnancy and excreted in the urine1  hCG is the marker of choice for detecting pregnancy and has a long and proven history in pregnancy testing2,3  Pregnancy can be tested either by holding the absorbent sampler of the device in the urine stream for 5 seconds or by dipping the absorbent sampler into urine collected into a clean container, for 20 seconds  The Conception Indicator feature is designed to estimate the time since conception occurred. This estimate assumes that conception occurred on the day of ovulation, which is defined as the day after the urinary LH surge The Conception Indicator feature works on a threshold basis of urinary hCG levels: there are three time  bands that give an estimate of 1-2, 2-3 and 3 or more weeks since conception. These thresholds are based on extensive research of urinary hCG rise in early pregnancy determined using the day after the LH surge as a marker for the day of conception

Threshold B

Threshold A

Average level of hCG

hCG level

3+ Weeks 2-3 Weeks 1-2 Weeks

Time since conception [weeks]

Figure One: Increasing levels of urinary hCG with time since conception.

Solid clinical foundations

LH is a hormone produced by the anterior pituitary gland. In females, at the time of menstruation, follicle stimulating hormone (FSH) initiates the growth of ovarian follicles, specifically affecting the granulosa cells. With the rise in estrogen levels, LH receptors are also expressed on the maturing follicle that in turn produces an increasing amount of estradiol. Eventually at the time of the maturation of the follicle, the circulating estrogen level leads, via the hypothalamic interface, to a release or surge of LH over a 24-48 hour period. This LH surge triggers the release of the egg (ovulation), and also initiates the conversion of the residual follicle into a corpus luteum that, in turn, produces progesterone to prepare the endometrium for a possible implantation.

2. Conception occurs very shortly after ovulation

 Studies have shown that the egg survives for only 0.7 of a day7 Studies have highlighted that the fertile period ends on the day of ovulation8-10  The results of a large, multicentre study demonstrated that conception most likely occurred on the day of  LH surge or day LH+111 Since conception occurs shortly after ovulation, the latter can be used as a proxy for the time of conception12

Evidence for using the day after LH surge as the day of conception
1. LH is a marker for ovulation
 The World Health Organization (WHO) has defined the rise in circulating LH as the best parameter for impending ovulation4 Levels of LH in urine correlate 100% with ultrasound detection of ovulation5  A prospective study using the Clearblue Fertility Monitor (formerly the Clearplan Fertility Monitor) found that  in cycles where the two days of peak fertility were detected, (day of LH surge and LH surge +1) ovulation was confirmed by ultrasound in 91.1% of cycles

% of maximum concentration

100 80 60 40 20 0 1 2 3 4 5 6 7 8 9 10 11 12 13

FERTILE PERIOD

DAY OF OVULATION ESTRADIOL

LH
14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Day of cycle

Figure Two: Mean changes in the concentration of hormones in peripheral venous plasma (expressed as a percentage of their maximum value relative to the day of the LH surge). Adapted from Collins (1985).13

The time of conception is most likely to occur on the day following the LH surge 

Thorough scientific basis

Human Chorionic Gonadotropin (hCG) is a peptide hormone produced in pregnancy that is made by the embryo soon after conception and later by the syncytiotrophoblast (part of the placenta). An important role of hCG is to prevent the disintegration of the corpus luteum of the ovary and thereby maintain progesterone production that is critical for a pregnancy in humans. The Conception Indicator feature uses urinary hCG levels to estimate time since conception.

State-of-the-art micro-semiquantitation
Inside a Clearblue Digital Pregnancy Test with Conception Indicator

Evidence for using hCG levels to estimate time since conception

Levels of hCG in serum and urine rise rapidly during the first days of pregnancy14,15  In studies absolute levels of hCG have been used to estimate gestational age16,17  Rigorous trials on approximately 3000 individual samples show there is a consistent pattern to urinary hCG levels during the first three weeks following conception18

4.900

 The Clearblue Digital Pregnancy Test with Conception Indicator uses a pioneering new approach and novel algorithm for measuring urinary hCG  Two strips are contained within the new Clearblue Digital Pregnancy Test with Conception Indicator a low

3.700

sensitivity strip and a high sensitivity strip  The Test monitors the Control line which is present on the low sensitivity strip, and the Results lines which

Log10 (hCG Conc + 0.10)

2.500

are present on both strips. Only when a valid Control line is detected will the result be determined  The Control and Result lines cannot be read by eye. Instead the test uses an optical system to measure the density of the lines a red light shines onto the control and result line zones, and the light reflected is

1.300

converted into an electrical signal Its revolutionary micro-semiquantitative technology distinguishes between four different possible results:  (see following page)

0.100

-1.100

8 9 10

12

14

16

18

20

22

24

26

28

30

32

34

36

38

40

42

Day relative to LH surge

Figure Three: Log10 (hCG) levels on the days following the LH surge (mean and 95% confidence interval of the mean shown).18

 The time since conception has been scientifically validated as being related to absolute quantities of hCG in urine

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Not pregnant result

Pregnant and conception occurred approximately 1-2 weeks ago

User-friendly and convenient

 The Clearblue Digital Pregnancy Test with Conception Indicator gives the result in words Pregnant or Not Pregnant providing a much greater degree of clarity than non-digital tests and ease of interpretation of the test result than with visual tests  If the test result is Pregnant, the Clearblue Digital Pregnancy Test with Conception Indicator uniquely also displays a result in numbers: 1-2, 2-3 or 3+, indicating that conception occurred approximately 1 to 2 weeks ago, approximately 2 to 3 weeks ago or more than 3 weeks ago

Not pregnant result

Pregnant and conception occurred approximately 1-2 weeks ago

No hCG detected by the assay strips, therefore a not-pregnant result is returned

Result line on high sensitivity strip exceeds the threshold set for 1-2 week result, but not the threshold set for a 2-3 result Result line on low sensitivity strip does not exceed the threshold set for 3+ week result

Pregnant and conception occurred approximately 2-3 weeks ago

Pregnant and conception occurred more than 3 weeks ago

Pregnant and conception occurred approximately 2-3 weeks ago

Pregnant and conception occurred more than 3 weeks ago

Result line on high sensitivity strip exceeds the threshold set for 2-3 week result Result line on low sensitivity strip does not exceed the threshold set for 3+ week result

Result line on high sensitivity strip exceeds the threshold set for 2-3 week result Result line on low sensitivity strip exceeds the threshold set for 3+ week result

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Boasts a wealth of clinical evidence

Numerous clinical and consumer studies have been conducted to establish the accuracy, reliability and ease of use of the Clearblue Digital Pregnancy Test with Conception Indicator. Studies were carried out among untrained healthy volunteer women who were attempting to conceive  Women tested the product at home for some studies or in a study centre for other studies  Studies were carried out in the laboratory using urine samples from women who had conceived, or who were seeking a pregnancy test  Studies were carried out using urine samples from women who had conceived and then subsequently obtained their gestational aging by ultrasound. Highlights of selected studies carried out with the Clearblue Digital Pregnancy Test with Conception Indicator are given in the next sections of this monograph. Consumers are informed of how to change weeks since conception to gestational age, using the information below, which can be found in the product information leaflet. This clear explanation may also help women understand how pregnancy is dated by healthcare professionals.

Reliable in detecting pregnancy

Study Objective: To demonstrate the accuracy of the Clearblue Digital Pregnancy Test with Conception Indicator Design: 400 women between the ages of 18 and 45 who were attending a clinic for pregnancy evaluation provided urine samples quantified for hCG using an extremely sensitive automated method. Expected Pregnant/Not Pregnant results predicted by the quantitative test were compared to actual results obtained by trained laboratory technicians using 3 different batches of the Clearblue Digital Pregnancy Test with Conception Indicator Results19:  1180/1184 results from the Clearblue Digital Pregnancy Test with Conception Indicator correlated with results predicted from the quantitative method  The overall accuracy of the Clearblue Digital Pregnancy Test with Conception Indicator in detecting pregnancy was 99.7%

Results from Clearblue Digital Pregnancy Test with Conception Indicator

Result expected from quantitative method How your doctor will date your pregnancy (based on a 28 day cycle) Not pregnant Pregnant All Not pregnant 820 0 820 Pregnant 4 360 364 Correlation 820/824 360/360 1180/1184

How to interpret the results

Results

Time since conception

Your result is Not Pregnant you may not be pregnant, or the level of pregnancy hormone may not be high enough to be detected, or you may have miscalculated the day your period was due

Table Two: Distribution of results from three different batches of the Clearblue Digital Pregnancy Test with Conception Indicator (combined) compared to results from the quantitative method

Conclusion: The Clearblue Digital Pregnancy Test with Conception Indicator demonstrated over 99% accuracy in detecting pregnancy when compared to a laboratory method

Your result is Pregnant and you conceived approximately 1-2 weels ago

3-4 weeks

Your result is Pregnant and you conceived approximately 2-3 weels ago

4-5 weeks

Your result is Pregnant and you conceived more than 3 weeks ago

5+ weeks

Table One: How the Conception Indicator result fits with doctors pregnancy dating (using last menstrual period [LMP]).

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Highly sensitive for pregnancy detection before the day the period is due
Early testing for pregnancy (testing before a period is due) can be of value to a woman if she is anxious about being pregnant, or if she is motivated to take steps to improve her lifestyle as early as possible following pregnancy. Study Objective: To demonstrate the sensitivity of the Clearblue Digital Pregnancy Test with Conception  Indicator in the detection of pregnancy on days before the period is due  Design: 89 women who conceived provided first morning urine samples every day during the cycle in which they became pregnant. Each sample was tested using the Clearblue Digital Pregnancy Test with Conception Indicator. The day their period should have been due was predicted from the LH surge which was detected in the samples Results19:

Accurate in determining time since conception

 Study Objective: To establish the accuracy of the Clearblue Digital Pregnancy Test with Conception Indicator in determining the time since conception  Design: 89 women who conceived provided first morning urine samples every day for 90 days from the first day of their period during the cycle in which they became pregnant. Samples from 7 days before the period was due (7 days post conception) to 28 days after the day the period was due (42 days post conception) were tested using the Clearblue Digital Pregnancy Test with Conception Indicator. Results of the Conception Indicator feature were compared to estimated time since conception based on detection of LH in the urine and taking LH+1 as the day of conception Results21:   The overall accuracy of the Clearblue Digital Pregnancy Test with Conception Indicator was 92% in estimating time since conception  The Clearblue Digital Pregnancy Test with Conception Indicator was 96.5% accurate if time since conception was 1-2 weeks, 76.1% accurate if time since conception was 2-3 weeks and 96.9% accurate if time since conception was more than 3 weeks

100 90 80 70 % of total 60 50 40 30 20 10 4 3 Days before period 2 1

96.7 85.8

98.3 Conclusion: The Conception Indicator feature provides an accurate estimate of time since conception and  is 92% accurate

55.0

Figure Four: Number of pregnancies detected with the Clearblue Digital Pregnancy Test with Conception Indicator.

Conclusion: The Clearblue Digital Pregnancy Test with Conception Indicator is highly sensitive and can  detect pregnancy up to 4 days before the day the period is due.

Pregnancy testing from the day the period is due is >99% accurate. Innovations in the field of pregnancy testing mean that women can test
for pregnancy before the day their period is due

 The day the period is due requires that a woman remembers the date of her last period and calculates from here, basing this calculation on
the expected length of her cycle. However, lengths of menstrual cycles can be variable in women14,19,20 and even taking the mean of the last three cycle lengths does not give an accurate prediction of the length of the current cycle

We recommend that women perform a pregnancy test on the day the period is due. However, as hCG levels rise quickly in early pregnancy,
many women can test positive before the day their period is due. If they test negative, but still suspect they are pregnant, women should wait 3 days or until their period is due and test again.

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Excellent pregnancy duration agreement with standardof-care ultrasound

 Study Objective: To determine the level of agreement between the Clearblue Digital Pregnancy Test with Conception Indicator and standard-of-care ultrasound in assessing pregnancy duration in a real-life, observational setting encompassing routine clinical care. Design: Women collected daily urine samples from day one of their next menstrual cycle. If any volunteer became pregnant, daily urine samples continued to be collected for 43 days after the LH surge. Samples from day -7 to day +28 relative to the day the period was due (LH surge +15 days) were tested using the Clearblue Digital Pregnancy Test with Conception Indicator. This categorised any resulting pregnancies into one of three groups: 12 weeks, 23 weeks, and 3+ weeks since conception. Information from the standard UK ultrasound dating scan was recorded by their midwife including the  expected delivery date.  Results22: Full data were available from 52 pregnant women who had conceived naturally. The agreement between the gestational age as calculated by the Clearblue Digital Pregnancy Test with Conception Indicator result and the exact midwife-recorded gestational age via ultrasound was 82.3%. However, when a 5-day range was applied to the ultrasound reading (as per routine UK clinical practice), the level of agreement was 98%. Conclusion: The Clearblue Digital Pregnancy Test with Conception Indicator provides a significantly high  (98%) level of agreement with standard-of-care ultrasound when assessing pregnancy duration in a reallife, observational setting which closely mirrors daily clinical practice. Conversely, when comparing LMP only 76.9% of women were found within the +/- 5 day range using ultrasound. Therefore Clearblue Digital Pregnancy Test with Conception Indicator was more accurate than LMP in dating pregnancy.

Conception result simple to interpret

Study Objective: To determine if the Clearblue Digital Pregnancy Test with Conception Indicator digital display of 1-2, 2-3 or 3+ weeks indicating the time since conception can be correctly read, easily understood and correctly interpreted Design: 101 untrained volunteers tested standardised samples of urine containing hCG expected to produce a Not Pregnant (0 mIU/ml), Pregnant 1-2 weeks (25 mIU/ml), Pregnant 2-3 weeks (200 mIU/ml) and Pregnant 3+ weeks (20000 mIU/ml) and compared their interpretation of the results with those of trained coordinators who read the same device Results21: 384/402 sample results interpreted by the volunteers were the same as those interpreted by the trained coordinators an overall agreement of 95.5% Conclusion: The digital result from the Clearblue Pregnancy Test with Conception Indicator is easy to read  and simple to interpret

Not pregnant result

Pregnant and conception occurred approximately 1-2 weeks ago

Number of samples

Percentage exact agreement

Percentage exact agreement within 5 days of ultrasound dating

95% CI

Agreement with ultrasound age reported by midwife (n= 52)

4,786

82.3%

98%

97.2100%

Pregnant and conception occurred approximately 2-3 weeks ago

Pregnant and conception occurred more than 3 weeks ago

Table Three: Analysis of Conception Indicator result compared to gestational aging assessment by ultrasound.

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Easy to use
114 consumers completed a questionnaire both at home and at a study centre on their experiences with the Clearblue Digital Pregnancy Test with Conception Indicator. They were asked to indicate whether they found the instructions for the Clearblue Digital Pregnancy Test with Conception Indicator very easy, easy or not easy to understand. Results21: 99.1% of women found the instructions  very easy or easy to understand.
Very Easy Easy Not Easy 78.9% 20.2% 0.9%

The test women most favour

114 consumers completed a questionnaire on their experiences with the Clearblue Digital Pregnancy Test with Conception Indicator and indicated whether they were more likely to buy a pregnancy test kit with a conception indicator, or less likely to buy one with this feature Results21:   92.1% (105/114) women said they would be more likely to buy a pregnancy test with a conception indicator feature than just a standard pregnancy test  93 women provided their own reasons for why they would like a conception indicator: these are shown in the Table below Number of Volunteers n (%) [N = 93] 50 (43.8%) 10 (8.7%) 8 (7%) 8 (7%) 5 (4.3%) 2 (1.7%) 3 (2.6%) 4 (3.5%) 3 (2.6%) 21 (16.4%)

114 consumers were asked to indicate on a 7-point scale how easy they found the Clearblue Digital Pregnancy Test with Conception Indicator to use, where 1 indicated very easy and 7 indicated very difficult. Results21: 93.8% women rated the device at scale points 1 to 3 for ease of use Conclusion: The Clearblue Digital Pregnancy  Test with Conception Indicator is easy to use and understand
Very Easy 76.3% 13.1% 4.4% 1.8% 0.0% 4.4% Very Difficult 0.0%

Reasons Nice to know when I conceived Price comparisons are more important Gives more information Appears more accurate/more reassuring Speed of test/easy to read Helps me plan when to see my doctor Takes anxiety away whilst waiting to see my doctor

Trusted by women
114 consumers completed a questionnaire both at home and at a study centre on their experiences with the Clearblue Digital Pregnancy Test with Conception Indicator using a 7-point scale, where 1 indicated very confident and 7 indicated not very confident in the test result. Results : 93.8% of women rated their confidence 
21

Dont know how helpful it is Other No response

Very Con dent 81.4% 11.5% 0.9% 0.9% 0.0% Not At All Con dent 3.5% 1.8% Not At All Con dent 3.5%
Table Four: Reasons why women would like a conception indicator feature.

 92/114 women (80.7%) said they would feel more confidence in a positive pregnancy result if there was also an indication of when they conceived

in the result at scale points 1 to 3 Conclusion: Women feel great confidence in  the results obtained with the Clearblue Digital Pregnancy Test with Conception Indicator

 Conclusion: A pregnancy test with a conception indicator feature is preferred by women

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Meets the needs of healthcare professionals

 Surveys were carried out among healthcare professionals (obstetricians/gynaecologists, family/general practitioners, nurse practitioners and midwives) to obtain their perceptions on the usefulness of the Clearblue Digital Pregnancy Test with Conception Indicator. Results21:  Opinions expressed included an unmet need for early pregnancy testing and evaluation of hCG  The majority of healthcare professionals were positive about the inclusion of a conception indicator with a pregnancy test  A high proportion of healthcare professionals considered that the Clearblue Digital Pregnancy Test with Conception Indicator could lead to some changes in their interaction with patients, open up more patient dialogue and promote greater awareness of pregnancy in general  Benefits of additional information for patients include: Planning for the pregnancy Modifying lifestyle Allowing women to seek pre-natal care early on Useful for giving an indication of delivery date

About SPD Swiss Precision Diagnostics GmbH

SPD Swiss Precision Diagnostics GmbH is a world leader in the research, design, production and supply of advanced consumer diagnostic products. Our brands, such as Clearblue and Persona are familiar in many countries, and are trusted for their accuracy and simplicity by women keen to know more about their own reproductive health. SPD brands are acclaimed for their pioneering innovation: Clearblue was the first brand to introduce a one-step pregnancy test, a one-minute test, a urine sample indicator, digitally displayed results and a Conception Indicator feature. At SPD, we are committed to helping people make informed decisions about their health and well-being, through a continuing flow of new and inventive developments. Our research centre is at the sharp edge of innovation, and is fully engaged in the development of reliable diagnostic products for better health and personal self-care. If you are a healthcare professional and wish to contact a member of the Clearblue support team about any product in the Clearblue range, please send an email to spdproductsupport@spdspark.com Alternatively, you could write to us at: SPD Swiss Precision Diagnostics GmbH 47 Route de Saint-Georges 1213 Petit Lancy Geneva Switzerland www.swissprecisiondiagnostics.com

 Conclusion: Most healthcare professionals felt that the Clearblue Digital Pregnancy Test with Conception Indicator would be useful to their practice and to their patients

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References
1. Vaitukaitis JL. Development of the home pregnancy test. Ann N Y Acad Sci. 2004; 1038:220-2 2.  Davies S, Byrn F, Cole LA. Human chorionic gonadotropin testing for early pregnancy viability and complications. Clin Lab Med. 2003; 23(2):257-64 3. Stephenson JN. Pregnancy testing and counseling. Pediatr Clin North Am. 1989; 36(3):681-96 4.  WHO Temporal relationships between ovulation and defined changes in the concentration of plasma estradiol-17 beta, luteinizing hormone, follicle stimulating hormone, and progesterone. I. Probit analysis. World Health Organization, Task Force on Methods for the Determination of the Fertile Period, Special Programme of Research, Development and Research Training in Human Reproduction. Am J Obstet Gynecol. 1980; 138(4):383-90 5.  Guida M, Tommaselli GA, Palomba S, Pellicano M, Moccia G, Di Carlo C, Nappi C. Efficacy of methods for determining ovulation in a natural family planning program. Fertil Steril. 1999; 72(5):900-4 6.  Behre HM, Kuhlage J, Gassner C, Sonntag B, Schem C, Schneider HP, Nieschlag E. Prediction of ovulation by urinary hormone measurements with the home use ClearPlan Fertility Monitor: comparison with transvaginal ultrasound scans and serum hormone measurements. Hum Reprod. 2000; 15(12):2478-82 7.  Ferreira-Poblete A. The probability of conception on different days of the cycle with respect to ovulation: an overview. Adv Contracept. 1997; 13(2-3):83-95 8.  Wilcox AJ, Weinberg CR, Baird DD. Timing of sexual intercourse in relation to ovulation. Effects on the probability of conception, survival of the pregnancy, and sex of the baby. N Engl J Med. 1995; 333(23):1517-21 9.  Dunson DB, Baird DD, Wilcox AJ, Weinberg CR. Day-specific probabilities of clinical pregnancy based on two studies with imperfect measures of ovulation. Hum Reprod. 1999; 14(7):1835-9 10.  Keulers MJ, Hamilton CJ, Franx A, Evers JL, Bots RS. The length of the fertile window is associated with the chance of spontaneously conceiving an ongoing pregnancy in subfertile couples. Hum Reprod. 2007; 22(6):1652-6 11.  Gray RH, Simpson JL, Kambic RT, Queenan JT, Mena P, Perez A, Barbato M. Timing of conception and the risk of spontaneous abortion among pregnancies occurring during the use of natural family planning. Am J Obstet Gynecol. 1995; 172(5):1567-72 12.  Lynch CD, Jackson LW, Buck Louis GM. Estimation of the day-specific probabilities of conception: current state of the knowledge and the relevance for epidemiological research. Paediatr Perinat Epidemiol. 2006 Nov;20 Suppl 1:3-12 13. Collins WP. Hormonal indices of ovulation and the fertile period. Advances in Contraception 1985;1:279-294 14.  Nepomnaschy PA, Weinberg CR, Wilcox AJ, Baird DD. Urinary hCG patterns during the week following implantation. Hum Reprod. 2008; 23(2):271-7 15.  Zegers-Hochschild F, Altieri E, Fabres C, Fernndez E, Mackenna A, Orihuela P. Predictive value of human chorionic gonadotrophin in the outcome of early pregnancy after in-vitro fertilization and spontaneous conception. Hum Reprod. 1994; 9(8):1550-5 16.  Rule AH, Michlewitz H, Boyle E, Donahoe M. Use of beta-human chorionic gonadotropin in gestational aging. Ann Clin Lab Sci. 1985; 15(5):428-34 17.  Fritz MA, Guo SM. Doubling time of human chorionic gonadotropin (hCG) in early normal pregnancy: relationship to hCG concentration and gestational age. Fertil Steril. 1987; 47(4):584-9 18.  Johnson SR, Miro F, Barrett S, Ellis JE. Levels of urinary human chorionic gonadotrophin (hCG) following conception and variability of menstrual cycle length in a cohort of women attempting to conceive. Curr Med Res Opin. 2009 Mar; 25(3):741-8 19.  Pike J, Ellis J, Johnson S, Shaw R, Parkinson P, Perry P. Accuracy of new Clearblue Digital Pregnancy Test with Conception Indicator. Hum Reprod 2010; 25(suppl 1):i169-170 20. Cole LA, Ladner DG, Byrn FW. The normal variabilities of the menstrual cycle. Fertil Steril. 2008 Apr 21. [Epub ahead of print] 21. Data on file 22. Johnson S et al. Agreement between the Clearblue Digital Pregnancy Test Conception Indicator and standard-of-care ultrasound dating in the assessment of pregnancy duration. Curr Med Res Opin 2011. In Press