Clearblue Connected Ovulation Test System

Healthcare Professionals Clearblue Connected Ovulation Test System

Clearblue® Connected Ovulation Test System

Maximises the chance of conception in a way like never before

  • The Clearblue Connected Ovulation Test System is the first and only dual-hormone ovulation test, now with smartphone app connectivity.
  • It combines a unique system that tracks two key fertility hormones with the convenience of an app, providing women with the accuracy of an ovulation test on their phonea, maximising their chances of conceiving in a way like never before
Connected Ovulation test

 

Features of the Clearblue Connected Ovulation Test System

  • The ability to detect estrone-3-glucuronide (E3G), a principal urinary metabolite of estradiol1 (rising levels of which are indicative of the onset of the fertile window),2 and luteinising hormone (LH) (a surge of which precedes ovulation).2,3
  • An accurate home-based method for detecting ovulation – over 99% accuracy for detection of the LH surge.4
  • Accurately adapts to a woman’s personal menstrual cycle to typically identify 4 or more fertile days5 – 2 days more than LH-only ovulation tests.
  • Bluetooth® technology which synchronizes test results to the app.b
  • Smart personalised reminders, based on fertility data.
  • The ability to enter information such as cycle length, bleeding, spotting, and dates of intercourse.
  • Cycle comparison, to enable easy tracking of fertility data and to facilitate discussion, for instance, with healthcare professionals.
Connected Ovulation test

Easy to read results

  • The ovulation test results are displayed on the test stick holder and are securely transferred to the app via Bluetooth®b
  • A clear circle will be displayed on the test stick holder when levels of E3G and LH are below the personalised algorithm levels, indicating Low Fertility – this result is displayed on the connected app, which also advises the user that intercourse at this time is unlikely to result in pregnancy and that she should test again tomorrow.
  • When a sustained rise in E3G is detected, the test stick holder will display a flashing smiley face indicating High Fertility – this result is displayed on the connected app with advice that intercourse today is associated with an increased chance of conception.  The user should test again tomorrow.
  • When the LH surge is detected, the test stick holder displays a non-flashing smiley face indicating Peak Fertility – this result is displayed on the app with advice that intercourse on this day will maximise chances of getting pregnant.
Connected Ovulation test - fertility level results

 

The Clearblue Connected Ovulation Test System is over 99% accuratea

  • The Clearblue Connected Ovulation Test System utilises disposable urinary ovulation test sticks to detect E3G and LH.
  • Using Bluetooth® technology, this information is automatically synchronised with the Clearblue Connected Ovulation Test System appb to provide women with accurate, scientifically based, personalised tracking, with alerts of their fertile days (both high and peak).
  • The Clearblue Connected Ovulation Test System is over 99% accurate for detection of the LH surge (indicative of impending ovulation)4 and uses an adaptive algorithm to typically identify 4 or more fertile days5 (Figure One), providing the user with more opportunities to plan intercourse and increase her chances of becoming pregnant sooner6,7
Levels of E3G and LH during a typical menstrual cycle

 

How the Clearblue Connected Ovulation Test System can help women

The Clearblue Connected Ovulation Test System provides women seeking to conceive with a valuable, user-friendly, easily accessible tool to help them to improve their fertility awareness and maximise their chance of conception.8

  • An estimated 1 in 2 couples may be trying to conceive at the wrong time9
  • The use of digital home-based ovulation tests has been shown to empower women with an increased understanding of their menstrual cycle10
  • Many women report that their use enabled effective planning of intercourse, offering them emotional support and making them feel less stressed when trying to conceive10
  • Randomised controlled clinical trials have also reported that the use of digital home-based ovulation tests does not increase stress in women trying to conceive11,12

Benefits of the Clearblue Connected Ovulation Test System over other apps

Many of the available fertility apps, based on calendar methods only, have been found to provide women with inaccurate information:

  • Calendar methods, which form the basis of many available apps, are unreliable due to intra-cycle variability in both cycle length and ovulation day; approximately 40% or more predicted fertile days fall outside of the 6-day fertile window13-15
  • A review found only 19% of free menstrual cycle apps were accurate, based on whether the menstrual cycle predictions were founded on ≥3 previous cycles, ovulation (when included) was predicted at 13–15 days prior to the next cycle, and no misinformation was included16
  • Another study found just three out of 33 free fertility apps accurately predicted the fertile window (based on a standard estimate of a 28-day cycle, with predicted ovulation on day 15, and fertile days from day 10–15)17

 

The Clearblue Connected Ovulation Test System is based on sound science and has been clinically validated

The technology used in the Clearblue Connected Ovulation Test System is supported by publications in peer-reviewed scientific/medical journals and has been validated in clinical studies.

Clearblue has published data on:

  • The accuracy of E3G and LH testing to predict the fertile window2,3,18
  • The accuracy of the fertility hormone assays used in the Clearblue Connected Ovulation Test system to detect the fertile window19–21
  • The ability of ovulation testing to increase the chance, and reduce the time, to conception6,7

Clearblue ovulation tests utilise LH assays clinically validated by comparison with ultrasound imaging of ovulation, showing 97% agreement with ultrasound observed timing of ovulation19

 

  • a Over 99% accurate at detecting the LH surge
  • b When Bluetooth® is switched on
  • *The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Clearblue is under license. Other trademarks and trade names are those of their respective owners.

 

  • 1 World Health Organization. Temporal relationships between indices of the fertile period. Fertil Steril. (1983) 39: 647–655
  • 2 Roos J, et al. Monitoring the menstrual cycle: Comparison of urinary and serum reproductive hormones referenced to true ovulation. Eur J Contracept Reprod Health Care. (2015) 20: 438–450.
  • 3 Johnson S, et al. Development of the first urinary reproductive hormone ranges referenced to independently determined ovulation day. Clin Chem Lab Med. (2015) 53: 1099–108.
  • 4 SPD data on file. Study of Clearblue® Digital Ovulation Test with Dual Hormone Indicator found >99% agreement with AutoDELFIA reference method in 100 cycles (all cycle had LH surge >40 mIU/mL).
  • 5 S Tiplady, et al. Detection of two urinary hormones by a new home ovulation test to identify the wider fertile window: a randomised comparative laboratory study of home ovulation tests. Human Reproduction (2013)28:i244;P309 ESHRE.
  • 6 Stanford JB, et al. Timing intercourse to achieve pregnancy: current evidence. Obstet Gynecol. (2002) 100: 1333–1341.
  • 7 Robinson JE, Ellis JE. 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: 301–306.
  • 8 McCartney PR. Nursing Practice With Menstrual and Fertility Mobile Apps. MCN Am J Matern Child Nurs (2016) 41: 61
  • 9 Zinaman, M., Johnson, S., Ellis, J., & Ledger, W. Accuracy of perception of ovulation day in women trying to conceive. Current Medical Research & Opinion (2012) 28(5), 749-754.
  • 10 Jones G, et al. Women's experiences of ovulation testing: a qualitative analysis. Reprod Health. (2015) 12: 116
  • 11 Tiplady S, et al. Home ovulation tests and stress in women trying to conceive: a randomized controlled trial. Hum Reprod. (2013) 28: 138–151.
  • 12 Weddell S, et al. Impact of home ovulation test usage on stress, psychological wellbeing and quality of life during evaluation of subfertility: a randomised controlled trial. In press (2017):
  • 13 Blake KR, et al. Standardized protocols for characterizing women's fertility: A data-driven approach. Horm Behav. (2016) 81: 74–83.
  • 14 Ellis J , S Johnson. Superiority of Clearblue® home ovulation tests in detecting the peak fertile days of the menstrual cycle compared to a simple calendar method. Hum Reprod. (2011) 26 (Suppl 1): i75–i77.
  • 15 Johnson S, et al. Can apps and calendar methods predict ovulation with accuracy? Curr Med Res Opin. (2018) 25: 1–8.
  • 16 Moglia ML, et al. Evaluation of Smartphone Menstrual Cycle Tracking Applications Using an Adapted APPLICATIONS Scoring System. Obstet Gynecol. (2016) 127: 1153–1160.
  • 17 Setton R, et al. The Accuracy of Web Sites and Cellular Phone Applications in Predicting the Fertile Window. Obstet Gynecol. (2016) 128: 58–63
  • 18 Godbert S, et al. Comparison between the different methods developed for determining the onset of the LH surge in urine during the human menstrual cycle. Arch Gynecol Obstet. (2015) 292: 1153–1161.
  • 19 Behre HM, et al. 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: 2478–2482.
  • 20 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. Hum Reprod. (2001) 16: 1619–1624.
  • 21 Bhiwandiwalla PP, et al. Assessment of the clearplan easy fertility monitor in couples seeking conception assistance. Obstetrics & Gynecology. (2001) 97: S29