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A recent study by Wesselink et al. (Am J Epidemiol. 2022;191(8):1383–1395) adds to the growing body of research finding that vaccination for coronavirus disease 2019 (COVID-19) is safe for individuals either seeking pregnancy or who are pregnant. The study’s authors found no effect of COVID-19 vaccination on fecundity in a population of individuals with no known infertility who were attempting conception. The finding reinforces the messaging of the American Society for Reproductive Medicine COVID-19 Task Force, the aim of which is to provide data-driven recommendations to individuals contemplating pregnancy in the face of the COVID-19 pandemic. As safe and effective COVID-19 vaccines became available, and with an increasing number of studies showing a heightened risk of severe disease during pregnancy, an important role of the Task Force is to encourage vaccination during the preconceptual window and in early pregnancy. The Task Force supports ongoing research to address gaps in knowledge about safe and effective therapies and preventive measures for individuals contemplating pregnancy and during pregnancy. Such research will help optimize care for reproductive-age individuals in the face of current and future health crises.

The emergence of the novel coronavirus disease 2019 (COVID-19) presented the field of reproductive medicine with many challenges due to an absence of data to guide clinical decision-making and inform patient counseling and management in the early days of the pandemic. Epidemiological studies rapidly filled key gaps in our understanding of the susceptibility of reproductive-aged women to the virus, transmission dynamics during pregnancy and lactation, and the effect of infection during the prenatal, pregnancy, and postpartum periods. This data guided the development of clinical guidelines written by the American Society for Reproductive Medicine as patients and clinicians navigated reproductive decisions during a time of uncertainty. We present a review of epidemiologic studies published between March and December 2020 that have directly informed prenatal and fertility care during the COVID-19 pandemic. Despite a significant increase in our knowledge base over the past year, many questions remain about the impact of COVID-19 on conception, pregnancy, fetal development, and lactation. In the future, a commitment toward inclusion of pregnant persons and those attempting pregnancy in the design of observational and interventional trials is necessary to gain earlier insights about outcomes and assist providers and patients in making data-driven decisions.

Scientific research using human embryos advances human health and offspring well-being and provides vital insights into the mechanisms for reproduction and disease. Research involving human embryos is ethically acceptable if it is likely to provide significant new knowledge that may benefit human health, well-being of the offspring, or reproduction.

To describe the experience of the ASRM COVID-19 Task Force over the past 2 years and to discuss lessons learned during the pandemic that can be applied to future public health crises.Descriptive narrative.None.Creation of the ASRM COVID-19 Task Force in March 2020.None.Effective pandemic management requires a joint effort on the part of physicians, scientists, government agencies, subject area experts and funders.Reproduction is a fundamental human right that should be protected at all times. Advanced preparation for future pandemics should include appointment of a standing group of experts so that a response is both informed and immediate when a public health crisis arises. This approach will help ensure that the ultimate objective - preserving the safety and well-being of patients and health care workers - is fulfilled. The recommendations put forth in this paper from the ASRM's Center for Policy and Leadership can be used as a template to prepare for future public health threats.

It is time to revisit the “14-day limit”

Many cancers presenting in children and adolescents are curable with surgery, chemotherapy, and/or radiotherapy. Potential adverse consequences of treatment include sterility, infertility, or subfertility as a result of gonad removal, damage to germ cells as a result of adjuvant therapy, or damage to the pituitary and hypothalamus or uterus as a result of irradiation. In recent years, treatment of solid tumors and hematologic malignancies has been modified in an attempt to reduce damage to the gonadal axis. Simultaneously, advances in assisted reproductive technology have led to new possibilities for the prevention and treatment of infertility. This clinical report reviews the medical aspects and ethical considerations that arise when considering fertility preservation in pediatric and adolescent patients with cancer.

Professionals who discover misconduct or other undisclosed information that would be material to the participation of another party (such as a donor, gestational carrier, intended parent, or lawyer) in an assisted reproductive technology arrangement should encourage disclosure to that party. In some instances, it is ethically permissible for the physician either to disclose material information to the affected party or to decline to provide care. In all cases involving the legal status or rights of the parties, referral to legal professionals is advised. This document replaces the document of the same name, last published in 2014 (Fertil Steril 2014;101:38-42).

Intended parents engage with gestational carriers in an attempt to achieve their personal reproductive goals. All gestational carriers have a right to be fully informed of the risks as well as the contractual and legal aspects of the gestational-carrier process. Gestational carriers have autonomy in making their own decisions regarding medical care and should be free from undue influences by the stakeholders involved. They should have free access to and receive psychological evaluation and counseling before, during, and after participating. Gestational carriers require independent legal counsel regarding the execution of contracts. This document replaces the document of the same name, last published in 2013 (Fertil Steril 2013;99:1838-1841).

Clinicians should encourage disclosure between intimate partners but must maintain confidentiality in cases where there is no prospect of harm to the partner and/or offspring. In cases where one member of a couple refuses to disclose relevant health information to the other partner and there exists a risk of harm to the unaware partner and/or offspring, clinicians may refuse to offer care and should decline to treat if full informed consent is not possible due to lack of disclosure.

Patient requests for transfer of embryos with genetic anomalies linked to serious health-affecting disorders detected in preimplantation testing are rare but do exist. This Opinion sets out the possible rationales for a provider's decision to assist or decline to assist in such transfers. The Committee concludes in most clinical cases it is ethically permissible to assist or decline to assist in transferring such embryos. In circumstances in which a child is highly likely to be born with a life-threatening condition that causes severe and early debility with no possibility of reasonable function, provider transfer of such embryos is ethically problematic and highly discouraged.

This opinion addresses the ethics of providing fertility treatment to women at elevated risk from fertility treatment or pregnancy. Providers ethically may treat women at elevated risk provided that they are carefully assessed; that specialists in their medical condition are consulted as appropriate; and that patients are fully informed about risks, benefits, and alternatives, including oocyte and embryo donation, use of a gestational surrogate, not undergoing fertility care, and adoption. Providers also may conclude that the risks are too high for them to treat particular patients ethically; such determinations must be made in a medically objective and unbiased manner and patients must be fully informed of the decision. Counseling of women who wish to initiate fertility treatment with underlying medical conditions that confer increased risk during treatment or pregnancy should incorporate the most current knowledge available, being cognizant of the woman's personal determinants in relation to her reproductive desires. In such a way, both physician and patient will optimize decision making in an ethically sound, patient-supportive context.

Financial "risk-sharing" fee structures in assisted reproduction programs charge patients a higher initial fee but provide reduced fees for subsequent cycles and often a partial or complete refund if treatment fails. This opinion of the ASRM Ethics Committee analyzes the ethical issues raised by these fee structures, including patient selection criteria, conflicts of interest, success rate transparency, and patient informed consent. This document replaces the document of the same name, last published in 2013 (Fertil Steril 2013;100:334-6).

INTRODUCTION The promise of uterine transplant as a fertility treatment for women who lack a functioning uterus experienced an early setback when doctors who performed the first such surgery in the USA announced its failure. In March 2016, surgeons at the Cleveland Clinic revealed the nation’s first transplanted uterus had to be removed because of a life-threatening yeast infection the recipient developed shortly after the novel surgery.1 The adverse clinical event transpired after the publication of Professor John Robertson’s timely and cogent analysis of uterine transplantation as a potential reproductive option,making ripe further debate about themerits of this emerging technology.2 In his article, Professor Robertson juxtaposes uterine transplantation against a woman’s decision to engage a gestational carrier to fulfill her desires for genetic parenthood. After weighing the ethical merits of endorsing one choice as superior to the other, Professor Robertson concludes ‘that there is a sound ethical basis to allow surrogacy or transplant to be used by women with uterine factor infertility’ regardless of the legal status of gestational surrogacy in the prevailing jurisdiction.3 We interpret Professor Robertson’s arguments, in part, to pose a thought experiment as he presupposes the yet unproven safety and efficacy of uterine transplantation to rival that of gestational surrogacy in the realm of assisted reproductive technologies (ART). While he is careful to qualify this assumption throughout the piece,making clear that ethical comparisons between awoman’s decision to seek transplant or surrogacy are based on a theoretical equivalency, he pays littlemind to another vital stakeholder in this reproductive scenario—thedeveloping fetus.Our commentary

The Ethics Committee recommends that in vitro fertilization (IVF) centers develop patient-centered policies regarding requests for futile treatment. In most cases, clear communication can avoid a direct conflict, but clinicians ethically may refuse to provide treatment believed to be futile or to carry a very poor prognosis. In certain instances, clinicians may provide limited treatment which they judge likely to be futile, but must be vigilant in their presentation of risks, benefits, and alternatives. This version replaces the previous published draft of this name (Fertil Steril 2012;98:e6-9).

This Ethics Committee report outlines the interests, obligations, and rights of all parties involved in gamete and embryo donation: both males and females who choose to provide gametes or embryos for use by others, recipients of donated gametes and embryos, individuals born as a result of gamete or embryo donation, and the programs that provide donated gametes and embryos to patients. This document replaces the document "Interests, obligations, and rights of the donor in gamete donation," last published in 2014.

Planned oocyte cryopreservation ("planned OC") is an emerging but ethically permissible procedure that may help women avoid future infertility. Because planned OC is new and evolving, it is essential that women who are considering using it be informed about the uncertainties regarding its efficacy and long-term effects.

Clinics may develop a policy to disallow selecting which embryos to transfer based on sex and choose to use only embryo quality as selection criteria. Clinics may also develop a policy to use randomization to select those embryos for transfer if more embryos suitable for transfer are available than can be transferred.

Preimplantation genetic testing for monogenic diseases for adult-onset conditions is ethically permissible for a range of conditions including when the condition is serious and no safe, effective interventions are available. The Committee strongly recommends that a genetic counselor experienced with PGT-M counsel patients considering such procedures. This document replaces the document titled "Use of preimplantation genetic diagnosis for serious adult-onset conditions: a committee opinion," last published in Fertil Steril 2013;100;54-7.

This document discusses the ethical implications of informing offspring about their conception using gamete or embryo donation. It replaces the 2013 ASRM Ethics Committee document of the same name (Fertil Steril 2013;100:45-9).

Medical science at its core aims to preserve health and eliminate disease, but a common theme in scientific discovery is the application of findings in ways that were not the primary intent. The development of diagnostic modalities to predict the health of resulting children has been a fundamental aim underpinning research into prenatal and preimplantation diagnostic modalities; however, the knowledge gained has in some cases been utilized for nonmedical purposes. As an example, amniocentesis developed to determine whether the pregnancy is chromosomally normal also provides information about the sex of the fetus, which normally does not affect health. The emerging gene-editing technologies that could be used to repair mutated disease-causing genes in an embryo will presumably also be able to be used to alter traits unrelated to disease. And yet, I will argue, the desire to preserve the mystery of reproduction remains a central value in humans' quest to reproduce. This yearning to maintain the mysteries will likely temper the development of strategies to alter our genome and affect the genetic identities of our offspring. In my experience as an obstetrician and reproductive endocrinology and infertility subspecialist, people want to have, not the best possible baby, but rather their own baby.

Fertility programs may withhold services from prospective patients on the basis of well-grounded reasons that those patients will be unable to provide minimally adequate or safe care for offspring. This document was reviewed and updated; this version replaces the previous version of this document, last published July 2013 (Fertil Steril 2013;100:50-53).

The use of adult intrafamilial gamete donors and gestational surrogates is generally ethically acceptable when all participants are fully informed and counseled, but consanguineous arrangements or ones that simulate incestuous unions should be prohibited. Adult child-to-parent arrangements require caution in order to avoid coercion, and parent-to-adult child arrangements are acceptable in limited situations. Programs that choose to participate in intrafamilial arrangements should be prepared to spend additional time counseling participants and ensuring that they have made free, informed decisions. This document replaces the document of the same name, last published in 2012 (Fertil Steril 2012;98:797–803).

Financial compensation of women donating oocytes for infertility therapy or for research is justified on ethical grounds and should acknowledge the time, inconvenience, and discomfort associated with screening, ovarian stimulation, and oocyte retrieval, and not vary according to the planned use of the oocytes, the number or quality of oocytes retrieved, the number or outcome of prior donation cycles, or the donor's ethnic or other personal characteristics. This document replaces the document of the same name, last published in 2007 (Fertil Steril 2007;88:305-9).

Cross-border reproductive care (CBRC) is a growing worldwide phenomenon, raising questions about why assisted reproductive technology (ART) patients travel abroad, what harms and benefits may result, and what duties health-care providers may have in advising and treating patients who travel for reproductive services. Cross-border care offers benefits and poses harms to ART stakeholders, including patients, offspring, providers, gamete donors, gestational carriers, and local populations in destination countries. This document replaces the previous document of the same name, last published in 2013 (Fertil Steril 2013;100:645–50).

Medical providers have an ethical duty to disclose clinically significant errors involving gametes and embryos as soon as they are discovered. Clinics also should have written policies in place for reducing and disclosing errors. This document was reviewed and affirmed in 2015 and replaces the earlier document of the same name (Fertil Steril 2011;96:1312–4).

Building families through the adoption of children has been supported by human society throughout history. The ethical appropriateness of patients donating embryos to other patients for family building, or for research, is well established and is affirmed by this Committee. The use of the term ‘‘adoption'' for embryos is inaccurate and should be avoided. This document replaces the ASRM Ethics Committee statement by the same name, last published in 2013 (Fertil Steril 2013;99:1846–7).

This document presents arguments that conclude that it is unethical to use somatic cell nuclear transfer (SCNT) for infertility treatment due to concerns about safety; the unknown impact of SCNT on children, families, and society; and the availability of other ethically acceptable means of assisted reproduction. This document replaces the ASRM Ethics Committee report titled, "Human somatic cell nuclear transfer and cloning," last published in Fertil Steril 2012;98:804–7.

Objective To describe live birth rates and predictors of success in 1-year age increments for women ≥40 years when initiating assisted reproductive technologies (ART). Design Retrospective database analysis. Setting A large university-affiliated infertility center. Patient(s) One thousand two hundred sixty-three women undergoing 2,705 ART cycles at age 40 or above. Intervention(s) Couples undergoing ART. Main Outcome Measure(s) Pregnancy and live birth rates per cycle start were determined based on 1-year increments in women aged ≥40. Predictors of success, including number of embryos transferred, number of fetal heartbeats, availability of embryos for cryopreservation, and cycle day 3 FSH levels, were analyzed. Result(s) The overall live birth rate per cycle start was 9.7%. Cumulative live birth rates in women ranged from 28.4% if starting ART at age 40 to 0 by age 46. The overall spontaneous abortion rate was 32.6% (range, 23.9%–66.7%). Higher pregnancy rates were predicted by the greater number of embryos available for transfer, by the availability of excess embryos for cryopreservation, and by the presence of two fetal heartbeats on ultrasound. The outcome of the first IVF cycle did not predict the outcome of subsequent cycles. Conclusion(s) Assisted reproductive technology has a reasonable chance for success (>5%) up until the end of the forty-third year. Twins on initial ultrasound, large numbers of embryos available for transfer, and the presence of excess embryos for cryopreservation predict higher live birth rates.

Recombinant follicle stimulating hormone (rFSH) has been in use in the management of infertility for the past decade. It is a virtually pure compound, with excellent batch-to-batch consistency and the ability to be produced in almost limitless quantities. A historical perspective leading to the development of recombinant products will be discussed, including a review of the two-cell, two-gonadotrophin theory of folliculogenesis. The two currently available recombinant follicle stimulating hormones (follitropin α and follitropin β) will be compared with each other and with urinary follicle stimulating hormone (uFSH) preparations. This comparison will highlight their safety, efficacy and side effect profiles. The use of recombinant follicle stimulating hormone in the special cases of polycystic ovarian syndrome and hypothalamic amenorrhea will be detailed. Finally, future directions in recombinant therapy will be considered, including the creation of long-acting preparations, the development of recombinant luteinizing hormone, and the potential future availability of more convenient administration systems.

Objective: To examine the gender differences found among couples when choosing the disposition of their frozen embryos. Design: Retrospective chart review. Setting: University affiliated in vitro fertilization (IVF) center. Patients: Couples undergoing their first cycle of assisted reproductive technology (ART). Intervention(s): None. Main Outcome Measure(s): Choice of disposition of gametes and embryos. Result(s): Gender bias is found when couples choose the dispositon of their frozen embryos, but not when they choose the disposition of their gametes. Conclusion(s): Gender bias was found in couples who made decisions regarding the disposition of their frozen embryos.

The rapid growth of reproductive medicine has in many cases occurred faster than societies have been able to assimilate the changes and incorporate them into the social fabric. Oftentimes, the widespread use of reproductive techniques and fertility-enhancing medications has occurred before the ethical implications of these technologies have been considered. This article introduces ethical concepts that can be used as tools to understand the moral dilemmas inherent in the practice of reproductive medicine. These concepts are then used to form a framework for discussing specific ethically charged issues including the increasing prevalence of multiple pregnancies and the option of multifetal pregnancy reduction, ethical considerations in the prevention of ovarian hyperstimulation syndrome, and access to fertility treatments among different populations. Furthermore, considerations of when to offer these technologies and situations in which care may be refused are discussed. In closing, the role of ethics committees as an approach to navigating difficult clinical situations is introduced.

Objective To determine whether the routine use of preimplantation genetic screening (PGS) in "good prognosis" women improves in vitro fertilization (IVF) cycle outcome. Design Randomized, controlled, prospective clinical study. Setting Private infertility clinic. Patient(s) Infertile women predicted to have a good prognosis as defined by: age 2 , presence of ejaculated sperm, normal uterus, ≤2 previous failed IVF cycles. Intervention(s) Patients were randomized to the PGS group or the control group on day 3 after oocyte retrieval; 23 women underwent blastomere biopsy on day 3 after fertilization (PGS group), and 24 women underwent routine IVF (control group). All embryos were transferred on day 5 or 6 after fertilization. Main Outcome Measure(s) Pregnancy, implantation, multiple gestation, and live birth rates. Result(s) No statistically significant differences were found between the PGS and control groups with respect to clinical pregnancy rate (52.4% versus 72.7%). However, the embryo implantation rate was statistically significantly lower for the PGS group (31.7% versus 62.3%) as were the live birth rate (28.6% versus 68.2%) and the multiple birth rate (9.1% versus 46.7%). Conclusion(s) In a "good prognosis" population of women, PGS does not appear to improve pregnancy, implantation, or live birth rates.

Objective To determine if there is an association between first IVF cycle outcome and subsequent delivery rate for women over 40 years. Design Retrospective data analysis. Setting Large, private academically affiliated IVF center. Intervention(s) Patients over 40 years of age undergoing IVF. Main Outcome Measure(s) Delivery rate compared between patients with a pregnancy loss versus a negative β-hCG in their first cycle. Additional factors including subsequent pregnancy losses, total number of IVF cycles, and delivery rates per cycle were also analyzed. Result(s) Among women who underwent their first IVF cycle over age 40, 8% of women had a pregnancy loss and 82% had a negative β-hCG in their initial IVF cycle. In the pregnancy loss and negative β-hCG groups, 17.9% and 21.9%, respectively, had a successful delivery in a future cycle. There were no further pregnancies leading to delivery after the fourth treatment cycle for the pregnancy loss group and the sixth treatment cycle for the negative β-hCG group. The average number of cycles and the number of subsequent pregnancy losses were similar in both groups. Conclusion(s) Outcome of initial IVF cycle is not prognostic of future delivery for women over the age of 40 years.

Objective To describe the ethical issues inherent to the current and foreseeable uses of preimplantation genetic diagnosis (PGD). Design Review of ethical principles and their application to PGD. Setting Academic medical center. Patient(s) None. Intervention(s) None. Main Outcome Measure(s) A discussion of the current ethical perils surrounding the use of PGD, and a prediction of future ethical quandaries that will arise from the use of this technology. Result(s) Although PGD may be used to predict and prevent disease, it may also be used to determine nondisease traits. The ever-expanding ability of genetics to determine qualities of the preimplantation embryo continues to open up new ethical questions relating to the use of PGD for preimplantation diagnosis. Conclusion(s) Preimplantation genetic diagnosis is a powerful technique with many positive applications. As with all such new technologies, care should be taken to ponder the ethical implications of its use before routinely accepting PGD as a tool in the reproductive armamentarium.

The aetiology of anomalous embryonic and fetal development of the female reproductive tract, ranging from common uterine abnormalities to the somewhat rare congenital absence of the uterus and vagina (CAUV), is unknown. Some have proposed that abnormal galactose metabolism might cause CAUV. An association between CAUV and the N314D allele of the galactose-1-phosphate uridyl transferase (GALT) gene has been proposed as aetiological. We tested this hypothesis further by performing a case-control molecular study analysing 32 patients with CAUV for the presence of the N314D allele. These patients were compared with 138 normal controls. No association between CAUV and the N314D polymorphism was found (P = 0.32). It is unlikely that either maternal or fetal GALT enzyme activity could affect paramesonephric duct development, because neither galactosaemic subjects nor their children have an increased incidence of uterine anomalies.

The initiation of GnRH antagonists when the lead follicle is >14 mm does not adversely affect IVF success rates and leads to a shortened duration of GnRH antagonist administration.