The Real Impact of the Alabama Supreme Court Decision in LePage v Center for Reproductive Medicine.

This Viewpoint breaks down the myriad ways the Alabama Supreme Court decision to declare frozen embryos as legal equivalents to children harms the health of mothers and fetuses, limits reproductive decision-making based on genetics and out-of-reach costs, and impedes research.

In vitro fertilization and andrology laboratory in 2030: expert visions.

The aim of this article is to gather 9 thought leaders and their team members to present their ideas about the future of in vitro fertilization and the andrology laboratory. Although we have seen much progress and innovation in the laboratory over the years, there is still much to come, and this article looks at what these leaders think will be important in the future development of technology and processes in the laboratory.

Disposition of unclaimed embryos: an Ethics Committee opinion.

Programs should create and enforce written policies addressing the designation, retention, and disposal of unclaimed embryos. In the absence of program-specific policies, it is ethically permissible for a program or facility to consider embryos to have been unclaimed if a reasonable period of time has passed since contact with an individual or couple; efforts as outlined in the consent form have been made to contact the individual or couple; and no written instructions from the individual or couple with dispositional control exist concerning disposition. In such cases, programs or facilities may dispose of unclaimed embryos by removing them from storage and thawing without transfer. In the absence of specific written instructions, unclaimed embryos may not be donated to others for reproductive use or be used in research. This statement replaces the American Society for Reproductive Medicine Ethics Committee document "Disposition of Abandoned Embryos" published in 2013.

Legal challenges in reproductive genetics.

Recent advancements in reproductive genetics have resulted in the availability of an extraordinary amount of new and detailed information for patients and providers. Whereas this information can inform many who are facing difficult clinical decisions, it can also introduce complex and uncertain choices. Expanded carrier screening and preimplantation genetic diagnosis for aneuploidy are important examples of new genetic techniques that are now widely used in reproductive medicine. This paper will explore these techniques through a medical-legal prism to better understand the opportunities and obligations incumbent on both patients and providers in this new age of genetic diagnosis.

Legal considerations in reproductive medicine.

Legal issues affect reproductive medical practice throughout the entire world. The breadth and depth of this interrelationship extend far beyond the scope of one series of articles in Views and Reviews. Given this limitation, we have chosen to present five topics, all different, but illustrative of key concepts that influence our practice of reproductive medicine. Our hope is that this "medical-legal sampler" will both inform and provoke thoughtful consideration of the ways we can best and most responsibly practice and serve our patients.

Selecting the optimal gestational carrier: medical, reproductive, and ethical considerations.

The goals of a gestational surrogacy relationship are to have a healthy baby for the intended parents while maintaining the medical and psychological well-being of the gestational carrier. A successful gestational surrogacy relationship will result also in good psychosocial outcomes for the gestational carrier, intended parents, and child. Finding a gestational carrier who will achieve these goals would be the ideal. This article focuses on key medical, reproductive, and ethical considerations to optimize clinical outcomes in gestational carrier cycles. Recommendations from available clinical guidelines regarding gestational surrogacy are reviewed, along with updates from current literature.

Gestational surrogacy: medical, psychosocial, and legal considerations.

Gestational surrogacy can provide an effective family-building method for women whose uterus is absent or dysfunctional and with contraindications to pregnancy, single men, and same-sex male couples. Over the past 30 years, gestational surrogacy cases have represented a growing percentage of third-party reproduction cases, both in the United States and internationally. The following series of articles provides a summary of current topics in optimizing GS arrangements. They focus on medical and psychological screening; psychosocial adjustment of carriers, children, and their families; legal considerations with precedent-setting cases that every clinician should know; and an international overview of cross-border surrogacy.

Legal principles and essential surrogacy cases every practitioner should know.

Gestational surrogacy, made possible with the introduction of in vitro fertilization, has expanded family building options while introducing novel challenges to established legal principles involving constitutional, contract, and family law as well as duty of care and negligence. Both legislatures and courts have grappled with how to apply these sometimes-competing areas of law to protect participants and professionals, and to create legally secure families. This article explores the following: the Constitutionally protected rights of privacy and reproductive autonomy of gestational surrogates; Contract Law principles that govern surrogacy contracts; the varied ways states have extended Family Law to establish legally recognized parent-child relationships between intended parents and children born to gestational surrogates; and the legal duties of care medical professionals owe to their patients.

Legal and ethical issues in cross-border gestational surrogacy.

This article aims to identify the main legal and ethical issues around international surrogacy. Owing to the legal diversity and ethical background of such a globalized practice, a review of the key existing literature on these two matters has been identified and analyzed. The article also identifies and analyzes the most significant legal solutions provided by supranational jurisdictions when dealing with cases of international surrogacy. The scope of the article includes the efforts to reach a minimum legal framework at the international level, with the aim not to standardize but to provide common legal solutions to those travelling abroad to have a child by means of surrogacy.

Infertility Services for Veterans: Policies, Challenges, and Opportunities.

Infertility prevalence and care needs among male and female Veterans are understudied topics. The Veterans Health Administration (VHA) medical benefits package covers full infertility evaluation and many infertility treatments for Veterans but not, by law, for their spouses. In vitro fertilization (IVF) is also specifically excluded from this medical benefits package by regulation. Congress passed a law in 2016 that allowed VHA to provide IVF to Veterans and their legal spouses, and broader infertility benefits to the legal spouse, if the Veteran has a service-connected condition associated with his or her infertility, with some limitations. As the Veteran population becomes increasingly female, research efforts in reproductive health, including infertility, are expanding and evolving. This includes a nationwide study currently underway examining infertility among male and female Veterans and associations with military-related trauma, such as injury, posttraumatic stress disorder, military sexual trauma, and toxin exposure. In this review, we describe the state of the science and policy on infertility care in the VHA along with challenges and opportunities that exist within the VHA system.

Personalized reproductive medicine: regulatory considerations.

Personalized medicine has many definitions. This term is often used synonymously with precision medicine, which is defined as the classifying patients with a disease or condition based on their phenotypic findings, such as biomarkers or genomics, into subpopulations that differ in their response to a specific treatment. Personalized medicine, however, can also mean the treatment of individual patients based on many contextual factors, such as response to therapy and patient preferences, in addition to predefined phenotypic findings. Regulatory approval for the marketing of a new drug or a new indication for a marketed drug requires a positive benefit risk profile and substantial evidence of effectiveness. The indication is based on the eligibility criteria and outcomes of the clinical trial(s) underpinning the regulatory approval. For precision medicine, drugs are often developed with companion diagnostics that are necessary for selection of the subgroup of patients, in contrast to personalized medicine which may be directed at a single patient. Most drugs are approved with a fixed dosage regimen for the approved population, but some drugs and biologics are approved with instructions to tailor therapy for individual patients, whether it be dosing, combination with other therapies, or selection among a class of medications. Hence, more often than not, personalized medicine directed at individual patients is achieved through the practice of medicine rather than regulatory action.

The (Re) Production of the Genetically Related Body in Law, Technology and Culture: Mitochondria Replacement Therapy.

Advances in medicine in the latter half of the twentieth century have dramatically altered human bodies, expanding choices around what we do with them and how they connect to other bodies. Nowhere is this more so than in the area of reproductive technologies (RTs). Reproductive medicine and the laws surrounding it in the UK have reconfigured traditional boundaries surrounding parenthood and the family. Yet culture and regulation surrounding RTs have combined to try to ensure that while traditional boundaries may be pushed, they are reconstructed in similar ways. This paper looks at the most recent RT to be permitted in the UK, mitochondria (mtDNA) replacement therapy (MRT). Despite controversial media headlines surrounding the technique, MRT is in fact an example of how science and regulation seek to expand models of traditional relatedness in a way that doesn't challenge the existing order. Yet, like other RTs, while attempts are made to ensure it doesn't push traditional boundaries too far, fissures and inconsistencies appear in law and culture, which give interesting insights into how genetics, parentage and identity are being mediated in new but familiar ways.

Good eggs? Evaluating consent forms for egg donation.

Beyond gaps in the provision of information, the informed consent process for egg donation is complicated by conflicts of interest, payment and a lack of longitudinal data about physiological and psychological risks. Recent scholarship has suggested that egg donation programmes could improve the informed consent process by revising consent documents. At a minimum, these documents should include information about eight key criteria: the nature and objectives of treatment; the benefits, risks and inconveniences of egg donation; the privacy of donors and their anonymity (where applicable); disclosure that participation is voluntary (withdrawal); the availability of counselling; financial considerations; the possibility of an unsuccessful cycle and potential uses of the eggs retrieved. This study evaluates the incorporation of these minimum criteria in consent forms for egg donation, obtained through requests to Canadian fertility clinics. Even when clinics were considered to have met criteria simply by mentioning them, among the eight consent forms assessed, none met the minimum standards. Only half of clinics addressed privacy/anonymity concerns, financial issues and the possibility of a future cycle. Improving the quality of consent documentation to meet the minimum standards established by this study may not be an onerous task. For some, this will include re-evaluating how they include one or two elements of disclosure, and for others, this will require a substantial overhaul. Using the criteria provided by this study as the minimum standard for consent could ensure that donors have the basic information they need to make informed decisions.