Clearblue ADVANCED Fertility Monitor

Healthcare Professionals Clearblue ADVANCED Fertility Monitor

The Clearblue Advanced Fertility Monitor is a unique innovation that has been shown to increase the chance of conception by 89%, in the first two cycles of use.1† It consists of a hand-held Monitor and disposable Test Sticks. It identifies changes in urine levels of two key hormones that control fertility, and is designed to accurately identify a woman’s full fertile window (the days leading up to, and including day of ovulation).2It is also the only fertility monitor that has a pregnancy testing function, as well as an intuitive touch screen display and other features that make it an effective and easy-to-use aid for women trying to conceive.

Fertility Monitor, test stick insertion

 

The fertile window can be identified by tracking two key hormones

There are only a limited number of days in each cycle when a woman can become pregnant.2 Many women are unaware, or miscalculate the timing, of their fertile window and may therefore not be having intercourse at the best time in the cycle in order to maximise their chances of conceiving.

- The menstrual cycle is controlled by the anterior pituitary gonadotrophins (follicle-stimulating hormone and luteinising hormone, LH) and the gonadal sex hormones (estrogen and progesterone)3
- Plasma estradiol is the major physiological determinant of the onset of the fertile window; it stimulates secretion of cervical mucus that is favourable for the survival and transport of sperm. Estradiol levels gradually rise in the early stage of the woman’s cycle, reaching a threshold that triggers a sudden increase in LH – the LH surge4
- The LH surge is the best indicator of impending ovulation; it causes the dominant follicle to rupture and release a mature ovum. Ovulation typically occurs 24–36 hours after the LH surge, and will not occur in its absence.5

Schematic of typical hormone levels found in urine throughout the cycle.

 

The Clearblue Advanced Fertility Monitor accurately identifies days of High and Peak fertility

The Clearblue Advanced Fertility Monitor gives women comprehensive, personalised information that is unique to each cycle. It employs patented technology which has been developed into a unique dual-hormone assay for estrone-3-glucuronide (E3G) and LH; E3G is recognised by the World Health Organization as a principal metabolite of estradiol6 and urinary levels of E3G correspond to the serum levels of estradiol.7

test day
- The touch screen display guides a woman through her cycle; it will prompt the user when to perform tests by displaying ‘Test day’

 

- The user performs a test by using a fertility Test Stick (contained within a purple foil) to obtain a urine sample, and then inserts the test stick into the Monitor to obtain a result
- The Monitor uses monoclonal antibodies and optical technology to track the levels of LH and E3G present in the urine. A sophisticated algorithm collects this information, along with menstrual cycle characteristics, and transforms it into a simple-to-understand indicator of fertility level

Low day
- Low is displayed on days when it is unlikely but not impossible that intercourse will result in pregnancy

 

High day
- High is displayed when the Monitor detects a rise in E3G, prior to a rise in LH, and indicates that there is a high probability that intercourse at this time may lead to pregnancy

 

Peak day
- Peak is displayed when the Monitor detects a surge in LH, which occurs 24–36 hours before ovulation, and indicates that the user is at the most fertile time in her cycle.

Increases the chance of conceiving by 89%1†

In clinical and laboratory studies of the Clearblue Advanced Fertility Monitor:

- It increased the chances of conception by 89% in the first two cycles of use1†
- It accurately detected hormone levels, when compared with serum hormone levels2†
- It was 99% accurate in detecting the LH surge, when tested using clinical samples8†
- It detected the LH surge in 96.6% of women, in clinical evaluations9†
- It has been shown to accurately predict ovulation compared with serum hormone measurements and vaginal ultrasound scans2,9†
- The mean duration of the combined high and peak fertility days detected was 6.01 ± 2.33 days, in a laboratory analysis of daily urine samples from 352 menstrual cycles10
- In a study of 54 couples who were seeking conception assistance, the Monitor identified a median of seven fertile days; more than 60% of cycles had between 1 and 5 days of high fertility, prior to peak fertility, over four cycles.11†

The Clearblue Advanced Fertility Monitor also accurately detects pregnancy

In addition to reading the dual-hormone assay for fertility hormones on fertility Test Sticks, the Clearblue Advanced Fertility Monitor can read pregnancy Test Sticks, which contain an assay for human chorionic gonadotrophin (hCG), an established and accurate marker for pregnancy.12,13

The Clearblue Advanced Fertility Monitor provides women with:

- An accurate indication of when her period is due. It calculates the due day using previous cycle information and the timing of the LH surge in the current cycle (LH surge plus 15 days); if this information is not available it will estimate assuming a 28 day cycle
- Pregnancy testing that is over 99% accuracy at detecting typical pregnancy hormone levels from the day the period is due14
PregnantNot Pregnant - A clear digitally-displayed result: ‘Pregnant’ or ‘Not Pregnant’
- Access to dates when pregnancy tests were performed and the test results, which are stored on the Monitor and displayed on the calendar screen for future reference

 

- Ability to test for pregnancy from 3 days before the period is due
– although Clearblue recommends that women test for pregnancy from the day that their period is due, the Monitor can detect pregnancy up to 3 days before the period is due. In clinical testing with early pregnancy urine samples the pregnancy detection rate was 96%, 91% and 74% at 1 day, 2 days and 3 days before the period was due, respectively15
- Accurate pregnancy testing for women of all ages – 100 urine samples from non-pregnant pre- (18–40 years), peri- (41–55 years) and post-menopausal (56–65 years) women were tested with three batches of the Monitor. The overall specificity of the Monitor for the detection of pregnancy was 100% (95% CI: 98.8–100%), and no false positive results were reported.16

Additional information can be input and stored in the Clearblue Advanced Fertility Monitor

Additional cycle information can be entered into the Monitor by the user, such as:

- Days and levels of menstrual bleeding
- Intercourse events; this data is useful to enable the user to track whether she has being having well-timed intercourse, she can then share this information with her healthcare professional if she does not become pregnant.

All information is displayed on a monthly summary screen and 6 month summary chart

The Clearblue Advanced Fertility Monitor displays all information collected and input, for the previous 6 months, on a monthly summary screen and cycle summary chart. This information can then be shared with healthcare professionals for review and analysis, should the user fail to become pregnant.

Monthly summary screen and explanation of symbols

Example monthly summary screen and explanation of symbols

The cycle summary chart screen displays data from the previous 6 months in a graph format. It displays a summary of length of cycle and days of High and Peak fertility, together with records for intercourse on High and Peak days.

Example cycle summary chart

Example cycle summary chart

Additional user functionality

Additional user functions of the Clearblue Advanced Fertility Monitor include:

- Option to set a PIN which the user will be asked to enter each time the Monitor is switched on
- The user can set an alarm to remind her when to test:
Example cycle summary chart this symbol will be displayed in the information bar to confirm an alarm has been set
- The Monitor will automatically set a testing window from 05.00 to 11.00 (as urine tests need to be performed on first morning urine) and the user can only perform a test during this 6 hour window. However, the user can change the timing of this testing window if they wish.

The Clearblue Advanced Fertility Monitor is:

Accurate – 99% accurate in detecting the LH surge in urine and over 99% accurate at detecting pregnancy7†,14*

Unique – provides daily fertility status by measuring two urinary hormones – LH and E3G and enables the user to test for pregnancy

Effective – designed to detect the entire fertile window17 to help women to conceive more quickly

Easy to use – intuitive and easy-to-use touch screen with simple to interpret digital display

Personalised – monitors individual hormone levels and adapts based on last six cycles of data**

Interactive – dates of intercourse and levels of menstrual bleeding can be input and stored on the Monitor for future use

Trustworthy – from Clearblue, the world’s number one selling brand in home pregnancy and fertility tests

Proven – to increase the chance of conception by 89%, in the first two cycles of use1†

  • Based on international sales in nearly 20 countries compiled using independent market research data.
  • Always read full instruction leaflet of product before use. This material is intended for healthcare professionals only. It is for general information only with no warranties, representations or undertakings, express or implied, and does not constitute medical advice. It may refer to products not yet registered or approved in a given country. Please ask your local pharmacist or SPD contact for products available in your country. Product images are for illustration only. Clearblue™ is a trade mark of SPD Swiss Precision
  • 1 Robinson J., et al. Increased pregnancy rate with use of Clearblue Easy Fertility Monitor. Fertility and Sterility. (2007) 87: 329–34.†
  • 2 Behre HM., et al. Prediction of ovulation by urinary hormone measurements with the home use Clearblue Fertility Monitor: comparison with transvaginal ultrasound scans and serum hormone measurements. Human Reproduction (2000) 12: 2478–2482. †
  • 3 Martinez AR., et al. Prediction and detection of the fertile period: the markers. International Journal of Fertility. (1995) 40: 139–155.
  • 4 Burger HG. Estradiol: the physiological basis of the fertile period. International Journal of Gynecology and Obstetrics. (1989) Suppl 1: 5–9.
  • 5 Kerin JF., et al. Morphological and functional relations of Graafian follicle growth to ovulation in women using ultrasonic, laparoscopic and biochemical measurements. British Journal of Obstetrics and Gynaecology. (1981) 88: 81–90.
  • 6 World Health Organization. Temporal relationships between indices of the fertile period. Fertility and Sterility. (1983) 39: 647–654.
  • 7 Catalan R., et al. Correlation between plasma estradiol and estrone-3-glucuronide in urine during the monitoring of ovarian induction therapy. International Journal of Fertility. (1989) 34: 271–275.
  • 8 Data on file: In laboratory testing, the Clearblue Fertility Monitor detected the LH surge in 169/171 cycles, in agreement with a quantitative radioimmunoassay. †
  • 9 Tanabe K., et al. Prediction of the potentially fertile period by urinary hormone measurements using a new home-use monitor: comparison with laboratory hormone analyses. Human Reproduction. (2001) 16: 1619–24. †
  • 10 Data on file. Laboratory Evaluation of Clearblue Fertility Monitor System Performance; 90 women contributed up to 5 cycles of daily early morning urine samples where the Clearblue Fertility Monitor system detected an LH surge, (352 cycles total) the range in cycle length was 22 to 40 days inclusive.
  • 11 Bhiwandiwalla PP., et al. Assessment of the Clearplan Easy Fertility Monitor (CPEFM) in couples seeking conception assistance. Obstetrics and Gynecology. (2001) 97: 29S.†
  • 12 Nepomnaschy PA., et al. Urinary hCG patterns during the week following implantation. Human Reproduction. (2008) 23: 271–277.
  • 13 Wilcox AJ., et al. Time of implantation of the conceptus and loss of pregnancy. New England Journal of Medicine. (1999) 340: 1796–9.
  • 14 Data on file. When compared to a laboratory refernce method, the Clearblue Advanced Fertility Monitor pregnancy test has been shown to be over 99% accurate at detecting pregnancy. 350 urine samples were tested, using 3 different batches of device. Reference method used: Perkin Elmer AutoDELFIA hCG.
  • 15 Data on file. Clearblue Advanced Fertility Monitor detected 74% of pregnancies 3 days before, 91% 2 days before, 96% 3 days before the period is due. Over 300 urine samples were tested on 3 different batches of device.
  • 16 Data on file: 100 urine samples from each cohort of pre, peri and post menopause non-pregnant women, were tested on three batches of the Clearblue Advanced Fertility Monitor. All testing gave a not pregnant result, the overall specificity was 100% (95% CI: 98.8–100%).
  • 17 Wilcox AJ., et al. Timing of sexual intercourse in relation to ovulation. New England Journal of Medicine. (1995) 333: 1517–21.
  • Studies conducted using the Clearblue Fertility Monitor. The chemistry used to detect E3G and LH in the Clearblue Advanced Fertility Monitor and the methodology used to convert test signals to fertility status are the same as those used in the Clearblue Fertility Monitor.

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