Overreliance on Ruptured Membrane Tests Linked to Fetal Deaths


AttentionLaboratory tests are not perfect. I hope this does not come to a surprise to anyone. In a perfect world, a lab test would always identify individuals with a specific condition from those who don’t have that condition. Unfortunately, we don’t live in that world and so lab test results must be interpreted beyond the “negative” or “positive” result or any other way in which a lab test result is reported. Human beings and their health and disease states are complicated and few lab tests can lump people into binary buckets of “yes” or “no.” That’s precisely true for tests of ruptured membranes that might be used during the course of a woman’s pregnancy.

We’ve written about tests for ruptured membranes before here and here. Rupture of membranes (ROM) is the term used to describe the breaking of the amniotic sac, as normally occurs before the onset of labor. If this happens earlier than the 37thweek of pregnancy it is called preterm ROM (PROM).

It’s important to detect women with ruptured membranes, particularly women with PROM, because PROM can lead to complications such as intrauterine infection, umbilical cord compression, and premature birth. Fortunately, there are tests to help identify pregnant women with ROM or PROM. The more reliable of these tests detect substances in amniotic fluid; and amniotic fluid is not normally present in vaginal fluid samples obtained from women with intact membranes. If these substances are detected, then it’s possible the fetal membranes have ruptured. But these tests are not foolproof!

The U.S. FDA recently issued a “letter to healthcare providers” about the risks associate with the use of tests for ruptured membranes. In this letter, FDA reminds providers that over-reliance on tests for ruptured membranes can lead to serious, adverse events. Note the “over-reliance” comment. It echoes what I state above, that lab test results are not perfect tests. FDA confirms that“ 13 fetal deaths and multiple reports of health complications in pregnant women” have been reported because of over-reliance on the accuracy of ruptured membrane tests. In this letter, FDA reminds providers that tests of ruptured membranes should be “part of an overall clinical assessment,”which usually includes physical examinationof the patient as well as tests to detect leaking amniotic fluid.

As laboratory professionals, it is incumbent upon us to continually stress the strengths and limitationsof the tests that are performed in our labs every day.

Thyroid Hormones and the Risk of Gestational Diabetes


Diabetes definitionThyroid hormones play an important role in glucose metabolism and homeostasis. They regulate hepatic gluconeogenesis, intestinal absorption of glucose, and glucose uptake in peripheral tissue. In addition, thyroid hormones modify circulating insulin concentrations. Thyroid function and metabolism undergo significant changes during pregnancy. For these reasons, thyroid hormones have been implicated in the development of gestational diabetes mellitus (GDM).

Published evidence has been conflicting about a possible relationship between overt or subclinical hypothyroidism and development of GDM. Recently, Rawal, et. al. reported an association between elevated concentrations of serum triiodothyronine (T3) and the ratio between elevated free T3 (fT3) and free thyroxine (fT4) ratio. This ratio is a surrogate marker for the body’s conversion of T4 to T3 and has been associated with development of GDM. 

The study was a multicenter and multiracial case-control study nested within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Fetal Growth Studies-Singleton Cohort.  GDM cases and 214 controls were included in the study. GDM was determined using the Carpenter-Coustan diagnostic criteria.   Blood was collected at four visits across pregnancy (targeted at gestational weeks8-13, 16-22, 24-29, and 34-37), and thyroid stimulating hormone (TSH), fT3, and fT4, were measured using the Roche Cobas e411. TSH concentrations that were ≤4 mIU/L were considered to be normal. Isolated low fT4 (hypothyroxinemia) was defined as having normal TSH with fT4 that was less than the 10th percentile of controls. Overt hypothyroidism was defines as elevated TSH with low or normal fT4 concentrations (less than the 90th percentile of controls).  

The authors reported that increased concentrations of fT3 and increased fT3:fT4 ratio were both associated with a greater risk of developing GDM even after adjusting for the pre-pregnancy body mass index and the family history of diabetes.  The fT3:fT4 ratio was most strongly associated with GDM with women in the highest quartile in the second trimester at a 14-fold increased risk, compared to women at the lowest quartile. Consistent with previous reports, the authors found lower concentrations of fT4 associated with GDM, but the associations were not significant after adjusting for confounders.

The authors suggest that higher fT3 concentrations (perhaps from increased conversion of T4 to T3) may be involved in the pathophysiology of GDM. They also conclude that their finding support the potential importance of thyroid screening for pregnant women. Naturally, these conclusions will need to be validated with a randomized controlled interventional study.

A New FDA-Approved Test for Predicting Preterm Delivery


Preterm baby

According to the March of Dimes, preterm birth occurs in approximately 10% of U.S. pregnancies. Until recently, cervicovaginal fetal fibronectin (fFN) was the only FDA-approved test for predicting preterm delivery in symptomatic women. We have blogged about fFN previously

Despite its FDA approval, fFN has limited clinical value. A condition with low prevalence, such as preterm delivery, has a low pre-test probability of occurring, hence a negative test result adds little to the assessment of the patient. Thus, a screening test for a low prevalence condition must demonstrate high positive predictive value (PPV) to be useful. The negative predictive value (NPV) of fFN is 99.5%, meaning a negative result is highly predictive that a woman will NOT deliver soon. However, PPV of fFN is only ~17%, meaning that less than 1 in 5 women with a positive test result will proceed to delivery with 7-14 days. For comparison, the PPV of flipping a coin in this population is 4%. Meta-analyses have supported the lack of utility for fFN.

In April 2018, the FDA approved cervicovaginal placental alpha macroglobulin-1 (PAMG-1), (brand name Parto Sure from QIAGEN) as a test for assessing the risk of spontaneous preterm birth in patients with symptoms of preterm labor.

Several recent studies have evaluated PAMG-1 for its ability to predict preterm birth.

Wing, et al. conducted a prospective study of pregnant women from 15 US sites, with signs or symptoms of preterm labor between 24 and 35 weeks of gestation with intact membranes and cervical dilations less than 3cm (>3 cm generally indicates active labor). They compared the utility of PAMG-1 to fFN. A summary of their key findings are shown in the table below.

Spontaneous preterm delivery ≤ 7 days

PPV

NPV

PAMG-1

19.0%

99.1%

fFN

6.5%

99.7%

     

Spontaneous preterm delivery ≤ 14 days

   

PAMG-1

25.0%

97.7%

fFN

11.1%

98.7%

Cervicovaginal PAMG-1 demonstrated similar negative predictive value and improved positive predictive value compared to cervicovaginal fFN.

Similarly, Melchor, et al. conducted a retrospective study of women with preterm contractions presenting to a single maternity hospital in Spain. They compared a one year period during which fFN was used to assess risk of pre-term delivery and a one year period where PAMG-1 was used. Similar to the Melchor study, patients were between 24-34 weeks of gestation with signs or symptoms of preterm labor and had intact membranes and a cervical dilation less than 3cm. A summary of their key findings are shown in the table below.

Spontaneous preterm delivery ≤ 7 days

PPV

NPV

PAMG-1

35.3%

98.3%

fFN

7.9%

97.9%

Both studies show improved positive predictive values for PAMG-1 over fFN. However, both studies reported sensitivities for PAMG-1 of 50%.  While this test can certainly be viewed as an improvement over fFN, PAMG-1 will only identify half of the women who will deliver within 7 day. Clearly a better marker to predict pre-term delivery is still needed.

Biodegradable Pregnancy Tests? What’s the big deal?


Recently, there was a buzz in the pregnancy testing world because a company called Lia Diagnostics received pre-market approval from the FDA for the first biodegradable pregnancy test that can be flushed down the toilet. When I excitedly emailed my co-blogger David about this, he said “Is that something that is really important to women?” This is a good question. Today I’d like to discuss why I think this type of product is important and take a look at the 510(K) premarket notification which is publicly available.

First, why is a flushable home pregnancy test important? One of the things that initially made home pregnancy devices attractive when they were first marketed back in the 1970’s is privacy.  They can be used in your own home. No need to go to a doctor or health center to find out if you are pregnant. You are the first to know in the privacy of your own home. However for some women, achieving privacy, even where they live, is difficult. Being able to flush the device down the toilet allows women to truly achieve privacy. No one will know the results or that the testing was even done.

The other reason that a flushable pregnancy device is important is environmental. Pregnancy devices are made from plastic and end up in land-fills. This is a huge burden on our environment and can no longer be ignored in the US or in developing countries, where these devices are also used. Imagine the environmental impact this device could have if it set a trend for other home pregnancy devices and other biomedical products to become biodegradable.  I feel that for this reason alone, this is a major milestone.

One thing that was not talked about in the press (and I could not find on the Lia website) is whether the packaging is also biodegradable & flushable. This will be key to achieve true privacy & environmental friendliness. In my laboratory, we do studies on pregnancy devices. Here I have included some photos of the trash we generated from just one study. As you can see, a great deal of that trash is packing material. This needs to be flushable and biodegradable too in order to achieve the company's goals of privacy & environmental friendliness.

Packaging trash

Six devices
Six devices

Trash generated from one of our home pregnancy device studies (property of Ann M. Gronowski)

Next, let’s take a look at the 510(K) pre-market notification for the Lia Pregnancy test. Lia compared their device to the OSOM hCG urine test. Our lab has studied the OSOM device in the past. In the summary document they show that the device can detect 100% of samples with an hCG concentration of 22 IU/L and 50% of samples at 14 IU/L. This is similar to other over-the counter devices on the market. Using 153 urine samples, the Lia device showed 100% concordance with the OSOM device. The device showed no cross reactivity with LH up to 500 IU/L and FSH & TSH up to 1000 IU/L. They evaluated the hook effect (something that can cause a false-negative result) up to 500 IU/mL (500,000 IU/L) which is good. They also checked for a hook due to hCG β-core fragment and showed no effect up to 500,000 pmol/L, which is a concentration at which we have previously demonstrated the OSOM device to give false negative results.

The Lia pregnancy test is scheduled to be available for purchase in mid-2018. Based on the data submitted to the FDA it sounds very promising. I hope that this novel product will induce other medical device companies take note and start to manufacture more biodegradable products.

New Guidelines from the American Thyroid Association on Thyroid Disease During Pregnancy


Thyroid tests
Early in 2017, the American Thyroid Association (ATA) issued new guidelines for the diagnosis and management of thyroid diseases during pregnancy and the postpartum.   This 74 page document covers everything from thyroid function testing during pregnancy, to thyroid autoantibodies and pregnancy complications and thyroid disease and lactation. It is a comprehensive and well written document that is a must-read for anyone interested in thyroid function and laboratory testing during pregnancy.  There is no way I can summarize the whole document here, but I did want to highlight what I think are some important take-home points for laboratorians.

 Normal Reference Intervals for TSH During Pregnancy

In 2011 the ATA guidelines suggested the upper reference limit for serum TSH be set at 2.5 mU/L during the first trimester and 3.0 mU/L in the second and third trimesters. The 2017 guidelines point out that there are now studies demonstrating substantial variation between populations.  The ATA recommended that when possible, population-based trimester-specific reference intervals for serum TSH should be defined and utilized. This is excellent advice, but very difficult for laboratories to establish. When local assessments are not available, the panel now recommends that in the first trimester the non-pregnant reference interval be lowered by 0.4 mU/L at the low end and 0.5 mU/L at the high end (which equates to an upper reference limit of around 4.0 mU/L). This is a significant change from their previous recommendation.

T4 Assessment During Pregnancy

There have been publications which raise uncertainty about free T4 (fT4) measurements using immunoassays in pregnancy. The ATA again recommends that when possible, population-based trimester-specific reference intervals for fT4 should be defined and utilized. Again, such intervals are very difficult for laboratories to establish. When this is not possible, in lieu of measuring fT4, total T4 measurement can be used with the upper reference interval increased by 50% to account for the increased thyroid binding globulin present during pregnancy. They also indicate that free thyroid hormones can be assessed using equilibrium dialysis LC/MS/MS. This method is considered the gold standard, but it is more expensive. They also suggest use of the fT4 index, but I personally think that whenever possible, fT4 by equilibrium LC/MS/MS or total T4 should be used whenever possible rather than this antiquated method. I recently wrote an opinion piece about on this topic. fT4 index should not be used as a substitute for trimester-specific reference intervals. The guideline suggests that isolated hypothyroxinemia (low fT4 with normal TSH), should not be treated.

Iodine Assessment During Pregnancy

There is substantial day-to-day variation in urinary iodine intake and excretion. As such, urinary iodine concentrations cannot be used to identify patients with iodine deficiency. They suggest that all pregnant women should ingest ~250 ug of iodine daily and that excessive doses of iodine should be avoided.

Patients with Thyroid Autoantibodies     

There are increasing data indicating that there appears to be a greater risk for adverse events such as preterm delivery in pregnant women with thyroid autoantibodies compared to those who are thyroid antibody negative. The guidelines suggest that euthyroid pregnant women who are TPOAb or TgAb positive have TSH measured at the time of pregnancy confirmation and every 4 weeks throughout pregnancy in order to monitor them for the development of hypothyroidism.

Hypothyroidism During Pregnancy

Overt hypothyroidism during pregnancy is well known to be associated with adverse pregnancy complications (such as premature birth, low birth weight and pregnancy loss) and detrimental effects on fetal neurocognitive development (such as low IQ). For this reason, treatment of overt hypothyroidism is recommended during pregnancy. However, as we blogged about recently,  screening for and treatment of subclinical hypothyroidism is still being debated. Because of the averse outcomes associated with elevated TPO antibodies (mentioned above) the panel does have specific recommendations with regard to the screening and approach to subclinical hypothyroidism.  First, pregnant women with TSH concentrations >2.5 mU/L should be evaluated for TPO status. Second, subclinical hypothyroidism should be approached as follows:

T4 therapy is recommended for:

  • TPO positive and TSH greater than pregnancy specific reference interval
  • TPO negative and TSH greater than 10 mU/L

T4 therapy is considered for:

  • TPO positive and TSH greater than 2.5 mU/L and less than upper limit of pregnancy specific reference interval
  • TPO negative and TSH greater than pregnancy specific reference interval but less than 10 mU/L

T4 therapy is NOT recommended for:

  • TPO negative and TSH within pregnancy specific reference intervals

The panel suggests that thyroid hormone replacement therapy should target a treatment goal of maternal TSH concentrations below 2.5 mU/L.

Anti-Mullerian Hormone: The Blood-Based Biological Clock?


Many women choose to delay starting a family for various reasons, but how long is too long to wait? Is there some way to determine the time remaining on a woman’s “biological clock” to help guide family planning? A new biomarker measured in blood, anti-Müllerian hormone (AMH), has been proposed to do exactly that but there are some important limitations that must be considered before rushing out to the closest doctor’s office to request an AMH measurement.

First, some background. Women are born with approximately one million primordial ovarian follicles and only about one thousand of these remain when a woman reaches menopause. Over the course of a woman’s reproductive years, these primordial follicles come out of hibernation and develop into immature follicles by accumulating theca cells that produce testosterone and granulosa cells that convert testosterone to estradiol. Each cycle, in response to follicle-stimulating hormone (FSH), one of these immature follicles becomes the dominant, mature follicle that ultimately releases an egg through the process of ovulation. Some immature follicles exit the development pathway and become nonviable while others continue to develop for possible selection as the dominant follicle in a subsequent cycle. The key point is that the granulosa cells of these immature follicles produce AMH, which can be measured in serum or plasma as a direct reflection of the number of immature follicles. If more immature follicles are present, the serum/plasma AMH concentration will be higher. If fewer immature follicles are present, the AMH concentration will be lower. At first glance, measuring AMH would seem to be the ideal way to determine a woman’s reproductive lifespan – if AMH is high, many immature follicles remain and menopause is years away.

Unfortunately, it’s not quite that simple. While elevated AMH concentrations do reflect a large number of immature follicles, this doesn’t necessarily guarantee fertility. Polycystic ovary syndrome (PCOS) is a condition marked by the presence of many immature AMH-secreting follicles and women with PCOS typically have elevated serum/plasma AMH concentrations. AMH has been shown to inhibit the effects of FSH and AMH excess prevents immature follicles from reaching the final stages of development, resulting in impaired fertility for many women with PCOS. While an AMH concentration within the age-appropriate reference interval is a favorable indicator of fertility, higher is not necessarily better as very high AMH concentrations may indicate an underlying anovulatory condition.

At the other extreme, low age-specific serum/plasma AMH concentrations have been associated with impaired fertility in women in their 30s and may predict earlier menopause but low AMH concentrations are substantially harder to interpret in girls and younger women – precisely the population for whom an early estimate of reproductive lifespan would be most valuable. Low AMH concentrations in healthy women in their teens and 20s have not been associated with impaired fertility and survivors of childhood cancers with low AMH concentrations have achieved pregnancy. Furthermore, circulating AMH concentrations are reduced by lifestyle factors like oral contraceptive use and smoking, complicating the connection between AMH concentration and reproductive lifespan.

While studies of large numbers of women show that a low age-specific AMH concentration is associated with earlier menopause, it’s difficult to predict the age at menopause for an individual woman using a serum/plasma AMH concentration. The rate of decline in serum/plasma AMH concentrations varies from woman to woman, meaning that two women with identical AMH concentrations one year may have very different AMH concentrations the following year. Furthermore, the onset of menopause is a complex trait determined by genetic factors, environmental exposures and other influences like smoking, alcohol consumption and previous pregnancies. Ultimately, while AMH does reflect the number of immature follicles, its ability to predict onset of menopause and guide family planning decisions is questionable at the present time.

Currently, the most appropriate clinical use of AMH measurement is to predict response to ovarian stimulation in women undergoing in vitro fertilization (IVF). Women with a high AMH concentration (and a large number of immature follicles) who undergo IVF are at increased risk of ovarian hyperstimulation syndrome (OHSS), a potentially fatal condition marked by abdominal fluid retention, blood clots, altered electrolyte concentrations and kidney failure. Using a moderate ovarian stimulation protocol in women with a high AMH concentration has been shown to reduce the risk of OHSS while increasing the number of pregnancies and live births per IVF cycle started. At the other end of the spectrum, women with a low AMH concentration are enrolled in a more intensive stimulation protocol to maximize egg retrieval while those with undetectable AMH are offered alternate treatment options as the chance of IVF success is low.

It’s possible that one day AMH may be routinely measured to predict the onset of menopause but for now, its most promising uses are limited to PCOS diagnosis (still some kinks to be worked out there too) and customization of ovarian stimulation protocols to improve IVF outcomes while minimizing the occurrence of OHSS.

Direct to Consumer Laboratory Testing Survey


Recruiting Material visit
Direct-to-consumer (DTC) laboratory testing permits consumers to order laboratory tests directly from a clinical laboratory without necessarily having to work with their healthcare provider. Currently nearly 40 states allow consumers to order some or all of their laboratory tests. This model of lab testing is relatively new in the United States and little is known about its impact on consumers.

However, many health care providers are concerned that consumers do not have enough background knowledge and information to make sound decisions based on their test results. Consumers might not understand what tests to order or how to interpret the tests.   It is unclear how often consumers share their results with healthcare providers and what action, if any, is taken based on the results. In addition, frequent test ordering in a normal population increases the chances of false (positive and negative) results. False results may give consumers a false sense of security when tests are normal or result in unnecessary alarm when tests are abnormal.

Recently an article in the medical journal JAMA expressed the opinions of many in the medical field that DTC testing may actually increase the cost of healthcare in the US.

However, many feel that there is value in allowing consumers to order laboratory tests through DTC laboratories and that there is not enough data to conclude that DTC testing adversely affects patient health or healthcare costs. This was expressed in a response to the JAMA article.

In order to gather data on the effects of DTC laboratory testing, a survey is being conducted to identify the reasons American consumers use DTC laboratories. The survey will quantify how frequently consumers of DTC test services order tests, define the most frequently ordered DTC tests, identify resources consumers use to understand DTC test results, and evaluate consumer engagement with health care professionals based on DTC test results.

If you have ever ordered your own lab tests from a direct-to-consumer laboratory, you may be eligible to participate in a research study from Washington University about direct-to-consumer lab testing.

Visit here  or copy this link
https://www.surveymonkey.com/r/DTCtestingSurvey 
to learn more or contact Dr. Ann Gronowski at 314-362-0194.

Zika Virus Testing in Pregnant Women: New CDC Recommendations


Zika3 figureWe have previously blogged about testing for Zika virus in pregnant women here and here. But testing recommendations continue to evolve.

As a result of increasing knowledge about the Zika virus, the CDC updated their recommendations.   The changes are based on declining trends in the number of reported cases of Zika virus infection in the Americas, emerging evidence on prolonged detection of Zika IgM antibodies, and new limitations for interpreting serologic tests during pregnancy. IgM is most likely to be detected in the first 12 weeks after infection but may persist beyond 12 weeks in some infected individuals, limiting the ability of testing to determine whether an infection occurred during or prior to pregnancy. False positive results and cross-reactivity with other flaviviruses can occur with IgM assays. Therefore, it is important to ascertain whether a woman had exposure to flaviviruses other than Zika virus before the current pregnancy because a positive IgM result might have been caused by cross-reactivity from a previous flavivirus exposure. Given the possibility of a false positive result, laboratory test results should not be released until all testing is complete.

Zika virus tests should be performed in:

  • Symptomatic pregnant women with possible exposure to Zika virus
  • Asymptomatic pregnant women with ongoing possible exposure to Zika virus
  • Pregnant women with possible exposure to Zika virus who have a fetus with prenatal ultrasound findings consistent with congenital Zika virus infection
  • Non-pregnant symptomatic individuals with possible exposure to areas with risk of Zika virus transmission

Zika virus testing may be considered for:

  • Asymptomatic pregnant women with recent possible but no ongoing exposure to Zika virus (i.e., travelers). Although not routinely recommended, testing may be considered on a case-by-case basis and in line with jurisdictional recommendations.

Zika virus testing is not recommended for:

  • Non-pregnant asymptomatic individuals
  • Pre-conception screening

The primary specimens for Zika virus testing should be paired serum and urine samples. Some emergency authorization tests may require other samples types. However, serum should always be obtained in case nucleic acid testing (NAT) testing is indicated after initial test results. NAT (on serum and urine) and IgM serological testing should be performed concurrently when testing symptomatic pregnant women. Specific guidance for laboratories is given by the CDC.

Another Update on Subclinical Hypothyroidism in Pregnancy


Thyroid DiseaseWe have blogged previously about the ongoing debate regarding the treatment of subclinical hypothyroidism in pregnancy (here and here).  In brief, there was a study published in 1999 that demonstrated that 7-9 year old children, from women with abnormal thyroid measurements during pregnancy, performed slightly less well than the control children on 15 IQ tests. Of the 62 women with thyroid disease who were not treated for their hypothyroidism 48 had children who had significantly lower IQ scores than the control children. This report led to a number of follow-up studies to support or refute this study.

Another one of the follow-up studies was recently published in the New England Journal of Medicine.  The authors screened women <20 weeks gestation for: subclinical hypothyroidism TSH ≥4 IU/L with normal fT4 (n=677); and women with hypothyroxinemia normal TSH with fT4 <0.86 ng/dL (n=526). Women in those two groups were then randomly assigned to receive levothyroxine or placebo. The dosage was adjusted each month to maintain normal TSH or normal fT4 (depending on which arm of the study they were in). The children were then followed for 5 years. The authors found that in the subclinical hypothyroidism group, the median IQ in the treated group was 97 and 94 in the untreated group.  In the hypothyroxinemia group, the median IQ was 94 in the treated group and 91 in the untreated group. There were no significant differences between groups in either arm of the study suggesting that there was no benefit to treating.

This study is consistent with the findings in the CATS trial which we have discussed previously. However, as discussed in an editorial about this article, both this study and the CATS trial are limited by the late initiation of treatment (17 weeks in this study). This is important because the fetal thyroid becomes active at 16-20 weeks of gestation, therefore the fetus relies on maternal T4 prior to that time.

The authors of the editorial concluded that because early intervention is feasible and may be beneficial, they still endorse the American Thyroid Association recommendations that suggest screening of certain high risk women and early treatment as indicated.  I suspect we will be blogging about this topic again in the future.

What is Oncofertility?


IVF_2Last week, at the annual meeting of the American Association for Clinical Chemistry (AACC) we heard an impressive presentation by Dr. Teresa Woodruff PhD on “Oncofertility.” Although the topic is a bit removed from laboratory testing, I thought it was still an important topic for this blog.

So what is oncofertility?  The term was coined by Dr. Woodruff to describe the merging of the fields of oncology and fertility. Its focus is to preserve the reproductive capabilities of women after undergoing treatment for cancer.

Every year 1.6 million people are diagnosed with cancer in the US. Most people associate cancer with old age, but 10% of those diagnosed are <45 years old. Due to more advanced and aggressive treatments, an increasing number of people are surviving cancer. Unfortunately, these cancer treatments can also cause infertility, sterility or early menopause. Men have the ability to freeze semen before undergoing treatment that may affect their fertility. But for women it is not that easy. They need to undergo ovarian stimulation to harvest mature eggs to be frozen for later use or for in vitro fertilization in which the embryo can be frozen for later use. Unfortunately, this process of ovarian stimulation may return only a handful of eggs and takes over a month which can delay life-saving treatment.

Now, there are also alternative experimental techniques that involve ovarian tissue banking.  In one method, a part or all of an ovary is removed and cryopreserved. Strips of ovarian tissue are then thawed and transplanted into the patient with the hope that immature follicles within the transplanted strips will begin to develop as they would in a normal ovary. To date, this has resulted in about 15 live births around the United States.

In her lecture, Dr. Woodruff also discussed in vitro follicle maturation. This technique is being investigated currently and involves taking ovarian tissue and, with the help of biomedical engineering, allowing the eggs to grow and mature outside of the body. This method is not yet available for patients, but is promising because it would not delay treatment for the patient and because potentially more eggs could be harvested.

The Oncofertility Consortium is a national group of interdisciplinary scientists, doctors and scholars that work to help women preserve their fertility. This is an important resource for women who plan to undergo treatment for cancer and want to preserve their reproductive capacity.