Guidance regarding gamete and embryo donation.

This document provides the latest recommendations for the evaluation of potential sperm, oocyte, and embryo donors as well as their recipients, incorporating recent information about optimal screening and testing for sexually transmitted infections, genetic diseases, and psychological assessments. This revised document incorporates recent information from the US Centers for Disease Control and Prevention, US Food and Drug Administration, and American Association of Tissue Banks, which all programs offering gamete and embryo donation services must be thoroughly familiar with, and replaces the document titled "Recommendations for gamete and embryo donation: a committee opinion," last published in 2013.

Storage, transport, and disposition of gametes and embryos: legal issues and practical considerations.

Cryopreservation of reproductive material has dramatically improved clinical outcomes for patients all over the world. At the same time the practice has produced significant legal, ethical, and practical challenges to physicians and practices who use this technique. Failing to meet the expectations of patients, for example by losing material because of a freezer failure, has significant implications for the reproductive facility. Similarly, improperly transporting or receiving gametes or embryos can result in substantial risk to a practice. Perhaps the most widely publicized conundrum is how best to manage embryos that are abandoned. This paper will describe the legal principles and best practices that should be incorporated into the management of a fertility cryopreservation program.

Preimplantation genetic testing as a component of root cause analysis of errors and reassignment of embryos in IVF.

The risks of embryo/gamete mix-up are a threat to the integrity of the IVF process, with significant implications for affected families. The use of preimplantation genetic testing through single-nucleotide polymorphism array or next-generation sequencing technology can help to identify, characterize and ultimately help, in some cases, to find the root cause, and to mitigate the extent of these errors for a given patient or laboratory.

The Fate of Unused Embryos: Discourses, Action Possibilities, and Subject Positions.

Although in vitro fertilization (IVF) has offered hope to those struggling with infertility, it has also had some unintended consequences, including the fate of embryos that may be "surplus" to requirement following IVF treatment. The number of embryos in storage across the world is high, creating a dilemma for patients who need to make disposal decisions, as well as presenting an administrative and practical dilemma for clinics. Research has suggested that patients' views of the status of their embryo/s may affect their disposal decisions, and yet the nature of the links between views of the embryo and decisions to either donate or discard remain unclear. In this article, we engage in a discursive analysis of literature on disposal decisions. We discuss the range of ways in which embryos may be constructed, and demonstrate how these discourses make available or constrain particular action possibilities, and offer particular subject positions for patients. The analysis highlights the complexity of the relationship between embryo status and decision making, and may assist clinicians in supporting and guiding patients' decisions.

Consentir na criopreservação de embriões: perceção de casais usuários de medicina da reprodução / Consent on embryo cryopreservation: perception of couples using reproductive medicine / Consentir en la crio-preservación de embriones: percepción de parejas usuarias de medicina de la reproducción

Este estudo qualitativo analisou as perceções de casais quanto aos fatores que contextualizam o consentimento livre e esclarecido na criopreservação de embriões, a partir de 34 entrevistas semiestruturadas, em Portugal. Analisaram-se os dados segundo os princípios da grounded theory. Dos resultados emergiram as seguintes necessidades: provisão de informações detalhadas, rigorosas, coerentes e no tempo adequado sobre os custos e duração da criopreservação e o destino dos embriões; reforço da privacidade física; tempo para refletir sobre o destino dos embriões e a divulgação da identidade dos beneficiários. As condições de aplicação do consentimento parecem ameaçar três dos seus elementos fundamentais: informação, voluntarismo e ponderação. Importa desenvolver orientações ético-profissionais que assegurem um consentimento assente em práticas de aconselhamento e prestação de informação adequadas às necessidades e expectativas dos pacientes.(AU)

This qualitative study analyzed couples' perceptions about the factors that contextualize informed consent regarding embryo cryopreservation, through 34 semi-structured interviews, in Portugal. Data were analyzed according to the principles of grounded theory. The results revealed the following needs: timely provision of detailed, accurate and intelligible information about the costs of cryopreservation, embryo storage limit and embryo disposition; reinforcement of physical privacy; availability of time to reflect about embryo disposition and disclosure of users' identities. The conditions of administration of the informed consent appear to threaten three of its fundamental elements: information, voluntarism and reflection. The development of professional and ethical guidelines is necessary to ensure the implementation of a consent process characterized by practices of counseling and information adapted to patients' needs and expectations.(AU)

Este estudio cualitativo analizó las percepciones de parejas en lo que se refiere a los factores que contextualizan el consentimiento libre e informado en la crio-preservación de embriones, a partir de 34 entrevistas semi-estructuradas realizadas en Portugal. Se analizaron los datos según los principios de la grounded theory. De los resultados surgieron las necesidades siguientes: provisión de informaciones detalladas, rigurosas, coherentes y en el tiempo adecuado sobre los costos y duración de la crio-preservación y el destino de los embriones; refuerzo de la privacidad física, tiempo para reflexionar sobre el destino de los embriones y la divulgación de la identidad de los beneficiarios. Las condiciones de aplicación del consentimiento parecen amenazar tres de sus elementos fundamentales: información, voluntarismo y ponderación. Es importante desarrollar orientaciones ético-profesionales que aseguren un consentimiento pleno en prácticas de aconsejamiento y prestación de informaciones adecuadas a las necesidades y expectativas de los pacientes.(AU)

Euploidy rates in donor egg cycles significantly differ between fertility centers.

Study question: Do external factors affect euploidy in egg donor cycles? Summary answer: The study demonstrates that during human assisted reproduction, embryonic chromosome abnormalities may be partly iatrogenic. What is known already: Chromosome abnormalities have been linked in the past to culture conditions such as temperature and Ph variations, as well as hormonal stimulation. Those reports were performed with older screening techniques (FISH), or ART methods no longer in use, and the subjects studied were not a homogeneous group. Study design, size, duration: A total of 1645 donor oocyte cycles and 13 282 blastocyst biopsies from 42 fertility clinics were included in this retrospective cohort study. Samples from donor cycles with PGS attempted between September 2011 and July 2015 were included. Participants/materials, setting, methods: PGS cycles from multiple fertility clinics referred to Reprogenetics (Livingston, NJ) that involved only oocyte donation were included in this study. Testing was performed by array comparative genomic hybridization (aCGH). Ploidy data were analyzed using Generalized Linear Mixed Models with logistic regression using a logit link function considering a number of variables that represent fixed and random effects. Main results and the role of chance: Euploidy rate was associated with the referring center and independent of almost all the parameters examined except donor age and testing technology. Average euploidy rate per center ranged from 39.5 to 82.5%. The mean expected rate of euploidy was 68.4%, but there are variations in this rate associated with the center effect. Limitations, reasons for caution: Data set does not include details of the donor selection process, donor race or ethnic origin, ovarian reserve or ovarian responsiveness. Due to the retrospective nature of the study, associations are apparent, however, causality cannot be established. Discrepancies in regard to completeness and homogeneity of data exist due to data collection from over 40 different clinics. Wider implications of the findings: This is the first study to show a strong association between center-specific ART treatment practices and the incidence of chromosome abnormality in human embryos, although the meiotic or mitotic origin of these abnormalities could not be determined using these technologies. Given the widespread applications of ART in both subfertile and fertile populations, our findings should be of interest to the medical community in general as well as the ART community in particular. Study funding/competing interest(s): No external funds were used for this study. S. Munne is a founding principle of Reprogenetics/current employee of Cooper Genomics. M Alikani's spouse is a founding principle of Reprogenetics/current consultant for Cooper Genomics. The remaining authors have no conflicts to declare.

Menopausal women requesting egg/embryo donation: examining health screening guidelines for assisted reproductive technology.

OBJECTIVE: As more postreproductive women opt to pursue pregnancy with advanced assisted reproductive technologies (ART), the menopausal practitioner will become more involved in counseling, screening, and referral of premenopausal, perimenopausal, and postmenopausal women for these services. This review was conducted with the aim of (1) evaluating ART screening practices as they pertain to postreproductive women, and (2) reviewing the outcomes of ART using oocyte donation in postreproductive women. METHODS: A total of 950 unique records were found on PubMed, Clinical Key, and Google Scholar. Of these, 252 records were screened for relevance based on their titles and abstracts. With further review of these 252 records, 93 full-text articles were assessed for eligibility, and 63 were excluded based on relevance to our study. Finally, 30 studies were included in our qualitative synthesis. RESULTS: Despite the increasing use of ART in postreproductive women, there are limited guidelines for determining candidacy with regard to maternal health, the most comprehensive of which are the guidelines from the American Society for Reproductive Medicine (ASRM). Although the American Society for Reproductive Medicine guidelines state that healthy women over 50 who are prepared for parenthood are candidates for ART through oocyte donation, they note that older women should be counseled as to the increased obstetric risk associated with advanced maternal age. With aging, particularly for those women who are menopausal and postmenopausal, the woman and her fetus, however, are at risk of increased morbidity and mortality as compared with younger, healthy pregnant women. Because national trends suggest that women are delaying childbearing, the cohort of postreproductive women looking toward ART using donor oocytes as a fertility option will expand and menopausal practitioners will often participate in the ART counseling of these women. CONCLUSIONS: Because maternal and fetal morbidity and mortality increase in postmenopausal women who become pregnant through ART, practitioners caring for this cohort should provide input into developing standardized, comprehensive guidelines for this population so that screening is consistent for all older women seeking this intervention and risks are objectively outlined and considered.

Informed consent and the use of gametes and embryos for research: a committee opinion.

The ethical conduct of human gamete and embryo research depends upon conscientious application of principles of informed consent developed in the context of clinical research. This document explores these principles, which entail, for example, that investigations occur under Institutional Review Board oversight. This document also discusses the complexities in obtaining informed consent from the persons whose gametes or embryos are being used in research but were originally intended for reproductive purposes. This statement replaces the document of the same name last published in 2004 (Fertil Steril 2004;82:S251-252).

Donating embryos for human embryonic stem cell (hESC) research: a committee opinion.

hESC research is an ethically acceptable use of human embryos that are in excess of those needed to meet the fertility goals of patients. The ethical basis for this view and issues to be considered during the informed consent process for the donation of embryos are developed in this document. This report replaces the Committee's 2009 report, "Donating spare embryos for stem cell research" (Fertil Steril 2009;91:667-70).

Recommendations for gamete and embryo donation: a committee opinion.

This document provides the latest recommendations for evaluation of potential sperm, oocyte, and embryo donors, incorporating recent information about optimal screening and testing for sexually transmitted infections, genetic diseases, and psychological assessments. This revised document incorporates recent information from the U.S. Centers for Disease Control and Prevention, the US Food and Drug Administration, and the American Association of Tissue Banks, with which all programs offering gamete and embryo donation services must be thoroughly familiar, and replaces the document titled, "2008 Guidelines for Gamete and Embryo Donation: A Practice Committee Report," last published in Fertil Steril 2008;90:S30-44.

Embryo disposition: the forgotten "child" of in vitro fertilization.

Cryopreservation of embryos is frequently employed in in vitro fertilization (IVF) practices because transfer of more than 3 embryos per cycle is not advantageous, and cryopreserved embryos offer fairly high pregnancy rates upon eventual transfer. Unfortunately, frozen embryos accumulate (approximately 4 per cycle). Thus, industrialized countries have developed laws or guidelines to govern their disposition, which may be disposal, or donation to medical research or to a recipient infertile couple. Worldwide, national regulations vary from eternal preservation to 10-year and 5-year preservation limits. The attitudes of couples who have undergone IVF range from almost parental concern for the embryos to regarding them as medical by-products--with little relationship to a couple's having a living child, in most studies. This paper describes disposition studies in various countries and couples' actions taken at time of disposition, with special detail on the problems involved in embryo donation to another couple.

Factors influencing the decision to use or discard cryopreserved embryos.

BACKGROUND: Couples' reasons for discarding supernumerary fertilized cryopreserved embryos and gender differences in attitudes toward the frozen embryos were investigated among Swedish couples undergoing in vitro fertilization (IVF) at a private clinic. At the time of the study Swedish law stipulated that couples could keep their frozen embryos for a maximum of one year, with the possibility of an extension based on individual requests. METHODS: A questionnaire with structured and unstructured questions was sent to 124 women and 124 men who had entered the IVF treatment and obtained supernumerary embryos from 1 January 1994 to 1 March 1995. Eighty-two women and 74 men completed the questionnaire. RESULTS: After a mean storage time of 25.3 (+/-11.0) months 22 (26.8%) of the responding couples had their embryos discarded. The reasons were mainly practical, such as a positive outcome of IVF and a legally too short storage time. Comparisons between women and men showed that fewer women (13;17.6%) than men (20;27%) had been uncertain during the IVF treatment about using the frozen embryos at a later date and that men more often than women expressed anxieties about possible effects of the freezing procedure on the potential child (p=0.009). CONCLUSION: A positive outcome of the original IVF treatment and a short maximum legal time of cryopreservation were the most common reasons why couples discarded their embryos. The men more often than women expressed anxieties about possible effects on a potential child. The results emphasize the need for giving detailed information to the couples about cryopreserved embryos and children born by this method.