The role of diagnostics in fertility and pregnancy

Every mother-to-be hopes for a healthy baby. Whether she is trying to get pregnant or is pregnant already, it is likely she has some concerns such as infertility, preeclampsia and Down syndrome.

The good news is that advanced diagnostic tests can equip women and their doctors with the information required to predict, diagnose and manage many of these conditions.

We recognise the enormous value of sensitive and reliable diagnostic information throughout pregnancy. Our commitment to constant innovation has yielded a portfolio of fertility and maternal tests that deliver highly accurate results to relieve uncertainty as well as support early and appropriate decisions.

Fertility issues affect 1 in 6 couples globally1 and can be a significant burden on couples in many ways, from psychological stress to the financial strain of high out-of-pocket costs of treatment. Male and female factors contribute equally to the ability to become pregnant.2 Understanding these factors encourages couples to make decisions about when to start planning for a family and the options available if there are fertility problems.

Diminished ovarian reserve is one of the major causes of infertility.3 As couples are waiting longer to have children, this becomes an important factor, as it is known that the ovarian follicle pool declines with age.4-7

At birth, women have about two million eggs in their ovaries. This is all of the eggs they will make in their lifetime. As women age, the number of eggs suitable for a viable pregnancy decreases in quantity and quality.7 Ovarian reserve test results give insight into the remaining eggs and the number of fertile years a woman has left.4

Anti-Müllerian hormone (AMH) is a very important and accurate marker of ovarian reserve. AMH testing can help physicians determine how many eggs remain in the ovaries and the likelihood of response to In-vitro Fertilization (IVF) drugs. AMH is produced in the growing follicles.4-6

An AMH test is a simple blood test and can be undertaken at any time of the menstrual cycle. It can be performed in a lab, hospital or specialised clinic and quickly and accurately delivers clear and reliable measures of AMH levels. Results are automated and don’t rely on a sonographer’s reading, which is required with antral follicle count (AFC), another method used to assess ovarian reserve.

AMH testing helps doctors guide patients on the course of treatment to help maximise the chances of conception while minimizing cases of Ovarian Hyper Stimulation Syndrome (OHSS), which may result in hospitalization and adverse events. New research is showing that it is possible to personalise the dosage of human recombinant follicle-stimulating hormone (rFSH) to be administered to women who are having their eggs harvested for IVF based on a woman’s specific AMH level.8,9 This may allow more couples to conceive through IVF.

Preeclampsia affects about 8.5 million women a year globally10, or 1 in every 20 pregnancies.11 Worldwide, about 76,000 pregnant women die each year from preeclampsia and related hypertensive disorders.12 An easy-to-use, novel test has been developed that can predict which pregnant women with suspected preeclampsia will or will not develop the condition. With results that are over 99% accurate,13 doctors are given the confidence to send healthy women home safely and to focus care on patients more likely to develop preeclampsia.13

Pregnant women are routinely encouraged to have screening for Down syndrome. Traditional screening tests miss one out of every four Down syndrome cases in pregnant women.14 However, a new, non-invasive DNA-based blood test that can be administered as early as 10 weeks in pregnancy has been shown to identify greater than 99% of cases, and has a false-positive rate of less than 0.1%.15 This test limits the number of unnecessary invasive procedures such as amniocentesis which are associated with a risk of miscarriage.

Diagnostic testing is available throughout pregnancy, from planning to gestation and post-birth. Clinicians can use diagnostics to monitor infants and pregnant women for congenital, perinatal and neonatal infections.

The accuracy of test results empowers healthcare professionals with valuable information to share with women and their partners and make informed clinical decisions.

References

1. European Society of Human Reproduction and Embryology.(Last accessed March 2018)

2. RESOLVE. Infertility FAQ. https://resolve.org/infertility-101/infertility-faq/ (Last accessed March 2017)

3. CDC. ART National Summary Report 2015 (October 2017).(Last accessed February 2018).

4. Jirge PR. J Hum Reprod Sci. 2011;4(3):108-113.

5. Maheshwari A et al. Hum Reprod. 2006;21(11):2729-2735.

6. Grynnerup AG et al. Curr Opin Obstet Gynecol. 2014;26(3):162-167.

7. Wallace WH et al. PLoS ONE. 2010;5(1):e8772.

8. Andersen AN et al. Fertil Steril 2016, “Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial” (open access)

9. Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 2 (ESTHER-2). https://clinicaltrials.gov/ct2/show/NCT01956123. (Last accessed December 2016)

10. Telang MA et al. Placenta. 2013;34(1):2-8.

11. Verlohren S et al. Am J Obstet Gynecol. 2010;202(2):161.e1-161.e11.

12. Preeclampsia Foundation. Preeclampsia and Maternal Mortality: a Global Burden. http://www.preeclampsia.org/health-information/149-advocacy-awareness/332-preeclampsia-and-maternal-mortality-a-global-burden. (Last accessed March 2018)

13. Vatish M et al. Ultrasound Obstet Gynecol 2016, “The sFlt-1/PlGF ratio test in preeclampsia: an economic assessment for the UK” (open access)

14. Sillence KA et al. Non-Invasive Screening Tools for Down’s Syndrome: A Review. Diagnostics. 2013;3(2):291-314.

15. Norton ME et al. N Engl J Med. 2015;372(17):1589-1597.