IVF storage tank failures spark reviews, lawsuits

March 20, 2018

Failure of liquid nitrogen storage tanks at two major infertility centers has led to a review of procedures at those and other similar facilities by them and the American Society for Reproductive Medicine (ASRM). Plus: Does MHT affect cardiovascular health? Also: Hirsutism treatment and diagnosis updated.

Failure of liquid nitrogen storage tanks at two major infertility centers has led to a review of procedures at those and other similar facilities by them and the American Society for Reproductive Medicine (ASRM). A least three lawsuits-one a federal class action-also have been filed by women whose eggs or embryos might have been damaged.

The first incident occurred on March 4 at University Hospitals Fertility Center in Cleveland. A statement issued by the Center said that it involved “an unexpected temperature fluctuation with the tissue storage bank where eggs and embryos are stored in liquid nitrogen.” An investigation is underway to determine the cause of the event. The Center reportedly had notified 700 patients that their eggs or embryos may have been damaged before a judge this week issued an order barring the facility from continuing to make such contact. 

A similar incident also occurred on March 4 at Pacific Fertility Clinic in San Francisco. The failure was in storage tank No. 4 and the Clinic is said to have notified 400 patients whose eggs and embryos were stored there. That incident, which is also being investigated, was reported to the College of American Pathologists, which certifies laboratories.     

The first lawsuit to arise because of the tank failure in Cleveland was filed by an Ohio couple. A Pennsylvania couple filed the second lawsuit, also against University Hospitals Fertility Center. In California, a class-action lawsuit was filed by a woman whose eggs were stored at Pacific Fertility Center.

In a statement issued after the incident in California, ASRM characterized the situation as “two major failures, apparently of equipment, redundancy and warnings, which have led to some tissue loss, though the extent of that loss is not yet fully determined.” The organization also noted that “cryopreservation and subsequent use of reproductive tissue is a technology that has been used reliably for years around the world.” To help members prevent other such incidents, ASRM is gathering its leadership and leading experts to review the facts and make recommendations to members and their patients.  

In 2016, ASRM issued a committee opinion about emergency planning for in vitro fertilization programs. Making a reasonable effort to maintain a stable cryoenvironment for cryopreserved oocytes, embryos, sperm, and other human tissue is among the recommendations in the document. After an emergency such as a hurricane, rising flood waters, or a severe snowstorm and when safe to do so, ASRM says efforts should be made to “replenish the nitrogen in the tanks containing the reproductive tissue.” The document does not make mention of equipment malfunctions.

NEXT: Does MHT affect cardiovascular health?

 

Does MHT affect cardiovascular health?

Menopausal hormone therapy (MHT) is not associated with adverse, subclinical changes in cardiac structure or function, according to a recent study published in PLOS ONE. Rather, women who use MHT were found to have a heart structure and function linked to a lower risk of heart failure.

The study authors used data from the UK Biobank to examine the structure and function of the left ventricle (LV) and left atrium (LA) in 1604 postmenopausal women who were free of known cardiovascular diseases. Thirty-two percent of the study group (n=513) had used MHT for at least 3 years. The researchers used multivariate regression models constructed with a cross product of age and MHT fitted as an interaction term.

MHT use was associated with significantly lower LV end diagnostic volume (122.8 mL vs 119.8 mL, effect size = -2.4%, 95% CI: -4.2% to -0.5%; P = 0.013) and LA maximum volume (60.2 mL vs 57.5 mL, effect size = -4.5%, 95% CI: -7.8% to -1.0%; P = 0.012). In other settings, smaller LV and LAS chamber volumes have been linked to favorable cardiovascular outcomes, including lower mortality and risk of heart failure. LV mass showed no significant difference. Increases in LV mass have been shown to predict a higher incidence of cardiovascular events and mortality.

The researchers noted a few strengths and limitations to this study. Among the strengths identified were use of a large population-based cohort and the uniformity of socioeconomic status between the MHT and non-MHT groups. Limitations were that all participants were menopausal, the MHT data were self-reported, information was lacking on the type of MHT used by the participants, and it was not possible to investigate longitudinal change in cardiac structure in relation to MHT use.

Ultimately, the researchers believe the results from this study show that the benefits of MHT to menopausal women outweigh any potential risks. However, women shouldn’t take MHT solely for the purpose of improving heart health, as this study doesn’t consider all of the ways MHT affects the cardiovascular system and more research is needed. 

NEXT: Hirsutism treatment and diagnosis updated

 

Hirsutism treatment and diagnosis updated

The Endocrine Society’s Clinical Practice Guideline on Hirsutism suggests that women with unwanted local hair growth be tested for polycystic ovary syndrome (PCOS), elevated androgen levels, and non-classical congenital adrenal hyperplasia (NCCAH). Originally published in 2008, the document was recently updated.

For diagnosis of hirsutism, one of the most impactful updates is the suggestion that almost all women with the condition should now undergo blood tests for testosterone and other androgens. Levels of these hormones tend to be elevated in women with PCOS. Originally, the Society suggested testing only in women with moderate to severe hirsutism but it has now broadened that in an attempt to improve diagnostic rates for PCOS.

Screening hyperandrogenemic women for NCCAH is suggested by measuring early morning 17-hydroxyprogesterone levels in the follicular phase. The results, the Society said, have important genetic implications for women desiring fertility. While the general message of the update was to increase screening, the organization recommends against testing for elevated androgen levels in eumenorrheic women because of the low probability that identifying a medical disorder would change management or outcome in them.

On the treatment side, the Society notes two main approaches to management of mild hirsutism in women with no evidence of an endocrine disorder: pharmacologic therapy and direct hair removal. These approaches can be used either individually or in combination but it makes sense to start with pharmacological therapies and add direct hair removal if needed in women with patient-important hirsutism. The Society defines patient-important hirsutism as unwanted sexual hair growth of any degree that causes sufficient distress for women to seek additional therapies.

It is also acceptable, the Endocrine Society said, to begin treatment with oral contraceptives (OCs) and antiandrogens in select women with severe hirsutism. In women at a higher risk for venous thromboembolism, lower-estrogen-dose OCs with low-risk progestins are recommended. While the Society does not suggest one OC over another, they do strongly recommend against using flutamide. In women with blonde or white hair, electrolysis should be used for direct hair removal rather than photoepilation.

To evaluate the original guidelines, the Endocrine Society appointed a task force of seven medical experts and methodologists to perform a network meta-analysis to compare the available 37 randomized controlled trials of pharmacologic therapy for hirsutism.