Clinically Proven | OvuSense Fertility and Ovulation Monitor

Clinically proven

Why OvuSense?

  • OvuSense was developed with the help of specialist clinicians and is specifically designed for women who are concerned about their fertility and/ or ability to conceive after 6 months or more of trying. You may be unsure of whether or not you ovulate and when it happens, and that's where OvuSense can help.

    OvuSense has two parts: an App and a Sensor. The OvuSense App allows you to sign-up your clinician, partner, family and friends so you can share your charts. The charts can be viewed by any shared user on any internet accessible iOS or Android device.

    • Clinically proven: OvuSense is the most advanced cycle monitoring system you can buy - clinically proven in over 10,000 cycles of use.
    • Real time 24 hour advance ovulation prediction: Unlike any other monitor, OvuSense provides a day's advance notice of when you are going to ovulate in real time along with your 4 day ovulation window - proven in clinical analysis to be correct 96% of the time.
    • 8 day fertile window: In addition, at the start of each cycle OvuSense provides a full 8 day fertile window - these features help you take back control of your planning for pregnancy.
    • Fully certified: OvuSense is a fully regulated medical device and complies with all the necessary certifications for the countries in which it is available - CE mark in Europe, FDA 510(k) in USA, CMDCAS in Canada, TGA in Australia.
    • 'Core temperature' technology: The rest of this page explains the clinical case for OvuSense's 99% accurate patented technology, and why other products produce an incorrect result in at least one in every five cycles.
  • Women with any degree of cycle irregularity (either in cycle length and/ or ovulation timing) will struggle with detection methods such as basal body temperature (BBT) and blood serum testing, because the irregularity makes these methods unreliable tools for prediction of ovulation.

    OvuSense was developed to provide the same benefit as LH tests by predicting the onset of ovulation up to one day in advance in real time in each cycle. However, unlike OPKs, OvuSense provides a clinically accurate detection of the exact date of ovulation, and can help you to diagnose any ovulatory conditions by showing you an extremely accurate picture of your progesterone levels throughout the cycle.

    As OvuSense takes temperature measurements in the vagina, it is not prone to the external influences which make traditional oral or skin measurement unreliable. Taking readings every five minutes each night means that OvuSense can create an extremely accurate set of values over a short period of time. By averaging out this data, OvuSense can 'look up' the temperature curve as soon as it finds the lowest point, and by reference to the extensive trial and field database assembled on OvuSense, the date of ovulation can be known in advance in real time.

    Papaioannou S, Aslam M et al. (2012) ESHRE, (2012) ASRM, (2013) ASRM and Papaioannou S, Delkos D et al. (2014) ESHRE - reporting on two clinical studies with 15 and 98 cycles have proven OvuSense has an:

    • accuracy of 89% for prediction a day in advance of ovulation (compared with accuracy of 60%-84% shown in the studies outlined above for LH strips)
    • accuracy of 99% for detection of the date of ovulation (detection not available with LH strips)
    • negative predictive value - for detection of anovulation (also not available with LH strips) of 94%.

    Perhaps most importantly, LH is only predictive of the onset of ovulation and cannot determine the date of ovulation or anovulation. Urinary LH measurement is therefore of little practical use for women who experience ovulatory disorders.

    Papaioannou S, Aslam M et al. (2013) J Obstet Gynaecol shows OvuSense is comfortable and easy to use, which is born out by over 10,000 cycles of use in the field. Combined with ultrasound folliculometry, OvuSense provides the optimum cycle management screening for diagnosis and treatment. OvuSense can be used as a diagnostic tool early in a couple's attempt to get pregnant. In addition, by using OvuSense, you can begin to better understand and spot cycle patterns in more depth. Many users have reported the benefit of tracking their fertility treatment and medications with OvuSense to see if they are having an effect, or not.


Who should use OvuSense

Who should use OvuSense?

  • Clinical studies show that around 25% of the total childbearing population suffer from one or more ovulatory issues, which rises to an estimated 70% of the population trying to conceive after 6 months.

    So if you've been trying for more than 6 months without success, there's a high chance you have an issue with ovulation. The good news is the issues are treatable, and the treatment can often solve the problem with conception.

    Ovulatory issues are broadly hormonal reasons which might cause you to ovulate irregularly or simply at a different time in the cycle than expected. Traditional thinking about predicting ovulation is based on the assumption that ovulation consistently occurs 14 days before the onset of the next period - so in the 'middle of your cycle' if you have a 28 day cycle. In fact, we now know that only a small percentage of women ovulate exactly 14 days before the onset of their period. Baird et al. (1995) - study size 221, Lenton et al. (1984 a & b) - study sizes 327 and 293 cycles, respectively.

    Ovulatory issues can contribute to this confusion. The most common ovulatory issues are described below:

  • Polycystic Ovarian Syndrome (PCOS) is a very common condition that affects up to one in 10 women of child bearing age. It is sometimes but not always accompanied by Polycystic Ovaries (PCO) – which is believed to affect around 20% of women. With PCO, many (poly) follicles (cysts) develop within the ovary without necessarily rupturing. If a follicle doesn’t rupture then no ovulation takes place.

  • Ovarian reserve (OR) is a measure of the quantity and quality of the follicles left in the ovary at any given time. The follicle is a fluid filled sac within which an egg (oocyte) develops. So Ovarian Reserve determines how well an ovary can produce eggs that are can be fertilized, resulting in a healthy and successful pregnancy.

    Diminished Ovarian Reserve (DOR) is known under a number terms including Poor/ Decreased/ Declining/ Low/ Impaired Ovarian Reserve, or Premature Ovarian Ageing. As a woman ages the number of follicles she has declines from approximately 2 million at birth, to 400,000 at puberty to 1,000 at menopause. The speed at which the follicle number declines varies from woman to woman, and some genetic and autoimmune conditions can accelerate the process.


How common are these ovulatory issues?

How common are ovulatory issues?

  • A number of studies have reported the high levels of PCO and the subset of PCOS, and potential reasons for poor detection rates:

    • 21-23% of the female population has PCO.
      Polson et al.(1988) – study size 257; Clayton et al. (1992) – study size 190; Farquhar et al. (1994) – study size 183
    • ~10% of the female population has PCOS.
      March et al. (2010) – study size 728, Sirmans et al. (2013) – quotes March and 3 other studies with 820, 929 and 392 women
    • Around half of women with PCO go undiagnosed.
      Kousta et al. (1999) – study size 278
    • PCO is found in 44% of women with unexplained infertility.
      Kousta et al. (1999)
    • 30% of women with PCOS have normal menses (and hence no apparent cyclical evidence of irregular ovulation).
      Balen A et al. (1995) – study size 1,741
    • Elevated levels of LH have been reported with potential greater prevalence in non-obese PCOS patients.
      Dale PO et al. (1992) – study size not available, Ciotta L et al. (1999) – study size 16.
    • Having no evident external manifestation of PCOS, non-obese patients are less likely to be suspected of having PCOS, and therefore have a lower chance of detection. Clinical observation.
  • Diminished Ovarian Reserve (DOR). The definition of whether a woman is 'suffering' from DOR is broad, because it is largely a progressive effect of ageing. Centers for Disease Control (2007, 2011) clinic statistics for the US show that the population entering into infertility treatment with DOR grew from 10% to 30% during the period 2007 to 2011 (the most recently available year)

    From the clinical study, Wallace and Kelsey (2010) – 8 studies with total 325 ovaries estimates that 95% of women by the age of 30 years only have 12% of their maximum pre-birth ovarian reserve remaining, and that by the age of 40 years only 3% of the reserve remains.

    As the average age for childbearing rises, so will the percentage of women that are trying to conceive with DOR. It’s therefore reasonable to assume that the population of women with DOR after trying to conceive for 12 months is currently around 10% and growing. DOR generally results in lower levels of reproductive hormones and hence most ovulation testing is impaired, both home based LH testing, and laboratory testing.

  • The statistics above probably also explain the extremely high percentage of women who have 'unexplained infertility' – i.e. no diagnosis of the cause of their inability to conceive throughout the patient pathway:

    • 30% after first diagnosis ASRM (2006)
    • 43% on entering IVF treatment, i.e. after last diagnosis HFEA (2013)

    We now know from other literature only a small percentage of women ovulate exactly 14 days before the onset of menses. Baird et al. (1995) - study size 221, Lenton et al. (1984 a & b) - study sizes 327 and 293 cycles, respectively. This being the case even for women who usually experience a 28 day cycle length. In addition, as Wilcox et al. (2000) – study size 221 demonstrated, the fertile window falls entirely between cycle days 10 and 17 in only about 30% of women. Most women reach their fertile window earlier and some much later. This 'norm' continues to become less common as couples attempt to conceive later in life.