41 papers

Joseph B Davis

Assistant Professor, Obstetrics and Gynecology, Icahn School of Medicine at Mount Sinai

Reproductive Ethics · ART Ethics

Disparities in access to effective treatment for infertility in the United States: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine. Electronic address: asrm@asrm.org, 2021 Fertility and sterility

In the United States, economic, racial, ethnic, geographic, and other disparities prevent access to fertility treatment and affect treatment outcomes. This opinion examines the factors that contribute to these disparities, proposes actions to address them, and replaces the document of the same name, last published in 2015.

Reproductive Ethics · ART Ethics

Financial compensation of oocyte donors: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2021 Fertility and sterility

Financial compensation of women donating oocytes for reproductive or research purposes is justified on ethical grounds and should acknowledge the time, inconvenience, and discomfort associated with screening, ovarian stimulation, oocyte retrieval, and postretrieval recovery and not vary according to the planned use of the oocytes or the number or quality of oocytes retrieved. This document replaces the document of the same name published in 2016.

Reproductive Ethics · ART Ethics

Human immunodeficiency virus and infertility treatment: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2021 Fertility and sterility

Human Immunodeficiency Virus is a serious but manageable chronic disease that affects persons of reproductive age, many of whom express a desire for biological parenthood. This document is a revision of the original document of the same name, last published in 2015 (Fertil Steril 2015;104:e1-8).

Reproductive Ethics · ART Ethics

Disposition of unclaimed embryos: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2021 Fertility and sterility

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.

Reproductive Ethics · ART Ethics

Ethics in embryo research: a position statement by the ASRM Ethics in Embryo Research Task Force and the ASRM Ethics Committee

Ethics in Embryo Research Task Force et al., 2020 Fertility and sterility

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.

Reproductive Ethics · ART Ethics

Interests, obligations, and rights in gamete and embryo donation: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2019 Fertility and sterility

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.

Reproductive Ethics · ART Ethics

Fertility treatment when the prognosis is very poor or futile: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2019 Fertility and sterility

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).

Anti-Infective and Anti-Inflammatory Agents · Immune Modulating Agents

A combination protocol of vitamin D, prednisone, aspirin, and vitamin B-folate complex improves ongoing pregnancy rates in pateints with recurrent pregnancy loss or multiple failed euploid single embryo transfer cycles

Pratt C et al., 2018 Fertility and Sterility

While preimplantation genetic testing (PGT) is increasingly being utilized to identify euploid embryos and to improve the likelihood of successful outcomes, many patients still experience recurrent pregnancy loss (RPL) and/or repeated implantation failure (RIF). Patients who experience RPL and/or RIF must cope with physical and emotional distress. Reproductive immunologists often utilize combination medication therapies to treat patients with RPL and RIF, however, these protocols often are not well supported by evidence-based research. This study evaluated the clinical outcomes for RIF and RPL patients who were treated with a specific combination protocol. Retrospective, cohort study. The study included patients who underwent single, euploid frozen embryo transfers (FET) with the combination medication therapy from 2014 - 2018. The combination medication protocol includes: Vitamin D, Prednisone, Aspirin and a Vitamin-B12/Vitamin B6/ Folate (CBF) complex. Patients with a history of R 2 failed euploid, single embryo transfers (SET), R 3 clinical spontaneous abortions (SAB), or a combination of 2 SABs and 1 failed SET were included in the analysis. Only patients who utilized autologous oocytes were included. A total of 54 IVF-FET cycles meeting criteria were included. Patient average age was 35.74 years old (range: 24 - 44). Upon review of the cycle outcomes, a total of 79.62% (n=43/54) achieved positive clinical pregnancy rates. Of those who attained a positive clinical pregnancy, 72.09% (n=31/43) reached at least 8 weeks gestation. Of those who passed the 8week gestation period, 74.19% (23/31) reached their estimated date of delivery and 91.30% of those (n=21/23) achieved live birth. A total of 14.81% (n=8/54) cycles resulted in clinical pregnancy loss and 7.41% (n=4/54) resulted in biochemical pregnancy loss. Finally, 20.38% (n=11/54) cycles resulted in negative pregnancy tests. While the etiology of RPL and RIF are not well understood, our study sought to identify an affordable and minimally invasive alternative treatment regimen. Due to the high levels of anxiety and distress associated with failed euploid embryo transfer cycles and spontaneous abortions, we sought to develop a new viable treatment strategy. Although the study was limited by sample size and design, the results were encouraging and future randomized control trials should be done to provide further support for this combination-medication treatment protocol.

Policy and Regulation · Access and Coverage Policy

Ensuring human rights in the provision of fertility care and infertility interventions

Van Der Poel S et al., 2018 Fertility and Sterility

There are reports that define the significant unmet need for access to fertility care and infertility interventions for heterosexual couples - those who experience involuntary childlessness and who desire a biological child. This need for access to care rarely measures those couples in non-heterosexual relationships, single individuals or in key/neglected populations. This disparity in recognition of need, and resultant lack of access to care is glaring. Universal access and attainment of the highest standard of care requires the provision of high-quality information and services that fulfills, protects and respects all individuals. The objective of this study was to identify the key principles that support access to fertility care and infertility interventions, and to provide a human rights framework to guide processes during the development of draft recommendations to the World Health Organization (WHO) for clinical practice. To evaluate the public health and human rights and gender impact on infertility, a literature review and systematic analysis were conducted to look at the following questions. What are the existing policies, public health directives and research evidence gaps impacting gender and human rights in the context of involuntary childlessness and infertility; and, What human rights principles guide the development and implementation of fertility care and infertility related laws, policies and systems? A detailed search strategy in collaboration with the WHO-HQ librarian, introducing various combinations of a predetermined set of terms was undertaken to identify primary literature, systematic reviews and gray literature, including documentation regarding current status of human rights and gender equality within policy and practices. Using the search strategy defined, we were able to identify 488 articles and documents, of which 102 were found appropriate. They were then categorized using 9 principles previously identified by WHO and used to address the topic of contraception. From this process, we generated a list of 12 principles which will be presented that cover issues such as non-discrimination, non-stigmatization as well as informed-decision making and autonomy, sharing of benefits and ensuring provision of care that includes the recognition of the health and well-being of the parent or parents as well as the children born. During the systematic review of the published data and evidence for the development of draft clinical recommendations to be presented to and for the World Health Organization consideration, it was clear that a human rights framework was required. Our systematic review process used research and policy evidence to support the development of a framework of principles that can better ensure different human rights dimensions are clearly and systematically integrated into the provision of fertility care information and fertility interventions and services.

Infertility Distress · Anxiety and Depression in Infertility

Importance of baseline psychological screening in infertility for men & women

Kruper A et al., 2018 Fertility and Sterility

By identifying psychological concerns early in the infertility treatment process, patients can be referred for behavioral health interventions rather than allowing conditions to emerge, worsen, or further impact their health. The aim of this study was to assess the psychological impact of infertility over time for men and women. Longitudinal prospective cohort study. Couples and individuals with a reproductive specialist consultation were recruited to complete two questionnaires: prior to initial consultation and at 12 months. PROMIS Anxiety and Depression 4-item short forms and Fertility Quality of Life (FertiQoL) were administered at both time points. We analyzed the relationships between FertiQoL, Anxiety, and Depression at 12 months, fertility-related events and outcomes (infertility diagnoses, medical treatments for infertility, pregnancy/parenting status), and sociodemographic characteristics (gender, age, race, education, relationship satisfaction) using hierarchical linear modeling to account for nonindependence of the participants who were part of a couple. We considered a two-tailed alpha level of 0.05 to be significant. A total of 88 women and 63 men provided data at both time points; mean age 34 years. At baseline, mean (SD) anxiety scores were 50.6 (8) for women, 48.4 (8) for men; depression scores were 46.8 (6) for women and 44.9 (4) for men. Baseline FertiQoL scores were 68.9 (15) for women and 79.8 (12) for men. By 12 months, 54% of participants were pregnant or parenting a child (birth or adoption/fostering). Those who were pregnant/parenting by 12 months reported significantly better FertiQoL scores and had lower depression at 12 months. Higher anxiety at 12 months was related to baseline anxiety and lower relationship satisfaction. Likewise, higher depression at 12 months was related to baseline depression and lower relationship satisfaction. Neither infertility diagnoses (male-factor, femalefactor, or unexplained) nor invasive medical treatments (IUI or IVF) were related to anxiety, depression, or FertiQoL scores at 12 months. Baseline psychological status is predictive of subsequent anxiety and depression during ongoing infertility treatment, with scores worsening over time. It is imperative that early identification of needs and provision of treatment resources be provided to patients. Embedding behavioral health services within the clinic promotes ease of access to care and reduces stigma of seeking treatment. After this research was conducted, the addition of a clinical health psychologist in the clinic has afforded opportunities to implement screening measures and promote early intervention.

Reproductive Ethics · ART Ethics

Misconduct in third-party assisted reproduction: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2018 Fertility and sterility

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).

Reproductive Ethics · ART Ethics

Use of preimplantation genetic testing for monogenic defects (PGT-M) for adult-onset conditions: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2018 Fertility and sterility

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.

Reproductive Ethics · ART Ethics

Planned oocyte cryopreservation for women seeking to preserve future reproductive potential: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2018 Fertility and sterility

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.

Reproductive Ethics · ART Ethics

Posthumous retrieval and use of gametes or embryos: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2018 Fertility and sterility

Posthumous gamete (sperm or oocyte) retrieval or use for reproductive purposes is ethically justifiable if written documentation from the deceased authorizing the procedure is available. Retrieval of sperm or eggs does not commit a center to their later use for reproduction, but may be permissible under the circumstances outlined in this opinion. Embryo use is also justifiable with such documentation. In the absence of written documentation from the decedent, programs open to considering requests for posthumous use of embryos or gametes should only do so when such requests are initiated by the surviving spouse or partner. This document replaces the report of the same name, last published in 2012.

Reproductive Ethics · ART Ethics

Disclosure of sex when incidentally revealed as part of preimplantation genetic testing (PGT): an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2018 Fertility and sterility

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.

Reproductive Ethics · ART Ethics

Ethical obligations in fertility treatment when intimate partners withhold information from each other: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2018 Fertility and sterility

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.

Reproductive Ethics · ART Ethics

Consideration of the gestational carrier: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2018 Fertility and sterility

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).

Infertility Distress · Anxiety and Depression in Infertility

A survey of preconceptual stress and a strategy for health optimization to give back control to an infertile population

Nazem TG et al., 2017 Fertility and Sterility

The care of infertility patients offers providers the unique opportunity to optimize health in the preconception phase. Assisting women to preemptively achieve a healthier lifestyle may not only improve fertility and pregnancy outcomes, but also diminish the psychological burden of infertility. The study sought to characterize modifiable lifestyle factors within an infertility population and address patient needs for lifestyle-based counseling before and after initial reproductive care consultation. Survey Patients presenting for an initial infertility consultation responded to a 26-item survey regarding clinical demographics, prior medical care, complementary medicine use, and perception of lifestyle habits and fertility prior to their visit. A follow-up 11-item survey was administered to determine the impact of the initial consultation. Questions were both structured and open-ended. Chi-squared, Spearman’s correlation, Mann Whitney U, Wilcoxon signed rank and McNemar’s tests were used for analysis. A total of 108 women (35.3  4.67 y) completed the preconsultation survey from 2016-2017; 26 women completed the follow-up questionnaire. Almost half (49.1%) were trying to conceive (TTC) for ≥12 months, with 14% trying for ≥2 years. Time TTC had a strong positive correlation with stress (r=0.48, p< .001) and a negative correlation with feeling control over fertility (r=-.21, p= .03). A longer time TTC correlated with greater likelihood of changing one’s lifestyle to be more fertility friendly (r= .26, p= .006), but those who made lifestyle adjustments also experienced more stress (p< .001). Participants who were up-to-date on their primary medical and dental care felt a greater sense of control (general practitioner: p= .01, dentist: p= .02) and less stress (dentist: p= .005) over their fertility. BMI had a negative correlation with interest in counseling on lifestyle (r= .2, p= .04). Women with a higher BMI were interested in weight management guidance (p= .005), but not in diet or physical activity counseling. Most respondents were interested in guidance on diet (88%), physical activity (84.3%) and mental health (75.9%), and 46% of women still desired direction on these factors after the initial visit. Prior to initial consultation, infertility patients may experience high levels of stress and feelings of uncertainty. A greater emotional burden is often encountered among women who spend a longer time TTC. Women may feel empowered if providers encourage them to engage with their primary care team earlier and offer methods to optimize their overall health and wellness. These interventions may help to alleviate anxiety and promote women’s sense of control during their infertility treatments. Fertility centers should consider the development of a mind-body program to optimize preconception health and enhance quality of life for women seeking fertility care.

Reproductive Ethics · Embryo Status

Patient attitudes towards the use of autologous cryopreserved embryos for fertility treatment

Adenuga OS et al., 2017 Fertility and Sterility

To evaluate couples’ perceptions of frozen embryos and their effect on fertility treatment decision making. Longitudinal, prospective, qualitative interview study of couples. Members of 37 couples participated in up to 6 semi-structured interviews over 12 months after scheduling an initial consultation with an infertility specialist (IS) - either a reproductive endocrinologist or urologist. Patients and their partners were interviewed separately by trained independent interviewers and were asked about their views on autologous cryopreservation at one-week and 12-months post consult. This is a secondary analysis of the interview data. Facilitated by NVivo analysis software, we categorized each participant’s comments into four categories and provide illustrative quotes for each. An exploratory study using qualitative data, this work was intended to generate hypotheses and inform future research directions rather than to make statistical comparisons. Initially, many participants expressed that they had no strong feelings regarding the use of autologous cryopreserved embryos, often admitting that they were unaware of what they were, but some participants did express strictly positive, strictly negative, or both positive and negative views (Table). At 12 months, more patients and their partners were familiar with the concept, and more participants discussed specific risks and benefits associated with freezing embryos and their storage. Those who opposed cryopreservation often cited moral or religious objections, but very few had strong enough negative views about embryo disposition to deter them from considering IVF as a treatment option. For most, other considerations, especially finances, were the primary barrier to pursuing IVF. Most patients and partners did not have strong views about autologous cryopreserved embryos after an initial appointment with an IS. At 12 months, stronger attitudes were apparent, but very few had strong enough negative views about embryo disposition to deter them from considering IVF as a treatment option.

Hormonal Agents · Gonadotropins

Efficacy of patient self-administered recombinant human chorionic gonadotropin (RHCG) is comparable to nurse administred RHCG in ovulation induction cycles

Pratt C et al., 2017 Fertility and Sterility

Infertility treatment requires patients to overcome a variety of physical, emotional, and financial obstacles. Often, patients express anxiety over self-administration of medications, including subcutaneous recombinant hCG (rHCG). Midluteal rise in progesterone (P4) levels to >3ng/dL suggest evidence of ovulation, and of R9ng/dL of adequate luteinization. Many patients express concern over whether they will adequately be able to self-administer medication. The study sought to determine if the rate and adequacy of ovulatory response is comparable whether a patient or a nurse administers the medication. Retrospective cohort study The study included patients who underwent ovulation induction cycles using either Letrozole or Clomiphene Citrate who had midluteal P4 levels measured on day +3 to day +10 following rhCG injection from March 2002 to March 2017. The primary outcome was rise in P4 (R9ng/dL). Patients were segregated into two groups based on who administered rhCG (Nurse-administered (RN); Self-administration (PT)). Secondary outcomes were clinical and biochemical pregnancy rates between the study groups and between patients with a P4 < or R9ng/dL. Chi-square test, t-test, and regression analysis were performed using SAS. Significance was confirmed with p<0.05. A total of 672 cycles met the inclusion criteria. All patient demographic, follicle size and count, and drug administration characteristics were included in the analysis. Regardless of whether a nurse or the patient herself administered rhCG, no significant difference was observed between midluteal P4 levels in patients (p=0.16). A post hoc power analysis revealed adequate sample size for RN vs PT administration group comparison. No differences were observed between pregnancy outcomes in RN vs PT administration groups. Midluteal P4 levels did significantly differ among cycles that resulted in pregnancy (p<0.0001) (both chemical and clinical), dominant follicle size (p=0.002), and number of follicles >18mm on day of trigger (p<0.0001). Ovulation rates following rhCG were greater than 95% across both groups. The rise in midluteal P4 is not diminished by self-adminstration of rhCG following ovulation induction with either Clomiphene Citrate or Letrozole. Due to the frequency of office visits, balancing work and family obligations is often difficult for patients undergoing fertility treatments. Patients can be reassured of their ability to properly administer medication at home; a finding that could reduce the amount of office visits and anxiety regarding self-administration.

Informed Consent · Patient Preferences and Priorities

A conceptual framework for patient-centered fertility treatment

Duthie EA et al., 2017 Reproductive health

Patient-centered care is a pillar of quality health care and is important to patients experiencing infertility. In this study we used empirical, in-depth data on couples' experiences of infertility treatment decision making to inform and revise a conceptual framework for patient-centered fertility treatment that was developed based on health care professionals' conceptualizations of fertility treatment, covering effectiveness, burden, safety, and costs. In this prospective, longitudinal mixed methods study, we collected data from both members (separately) of 37 couples who scheduled an initial consult with a reproductive specialist. Data collection occurred 1 week before the initial consultation, 1 week after the initial consultation, and then roughly 2, 4, 8, and 12 months later. Data collection included semi-structured qualitative interviews, self-reported questionnaires, and medical record review. Interviews were recorded, transcribed, and content analyzed in NVivo. A single coder analyzed all transcripts, with > 25% of transcripts coded by a second coder to ensure quality control and consistency. Content analysis of the interview transcripts revealed 6 treatment dimensions: effectiveness, physical and emotional burden, time, cost, potential risks, and genetic parentage. Thus, the revised framework for patient-centered fertility treatment retains much from the original framework, with modification to one dimension (from safety to potential risks) and the addition of two dimensions (time and genetic parentage). For patients and their partners making fertility treatment decisions, tradeoffs are explicitly considered across dimensions as opposed to each dimension being considered on its own. Patient-centered fertility treatment should account for the dimensions of treatment that patients and their partners weigh when making decisions about how to add a child to their family. Based on the lived experiences of couples seeking specialist medical care for infertility, this revised conceptual framework can be used to inform patient-centered treatment and research on infertility and to develop decision support tools for patients and providers.

Reproductive Ethics · ART Ethics

Child-rearing ability and the provision of fertility services: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2017 Fertility and sterility

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).

Reproductive Ethics · ART Ethics

Transferring embryos with genetic anomalies detected in preimplantation testing: an Ethics Committee Opinion

Ethics Committee of the American Society for Reproductive Medicine, 2017 Fertility and sterility

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.

Reproductive Ethics · ART Ethics

Using family members as gamete donors or gestational carriers

Ethics Committee of the American Society for Reproductive Medicine, 2017 Fertility and sterility

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).

Reproductive Ethics · Third Party Reproduction

Decision making by patients seeking care for fertility problems

Cooper A et al., 2016 Fertility and Sterility

To describe how couples navigate infertility treatment decisions, including how they deliberate and reach consensus on plans for family building, how they adapt their plans as treatment progresses, and how they view past decisions. Longitudinal, mixed-methods study on infertility decisionmaking among couples making an initial appointment with a reproductive specialist (RS) at an academic medical center in a Midwestern state without a health insurance mandate. We used interview and survey data to construct the treatment paths couples pursued considering financial and emotional resources and decision-making approaches. Each member of 37 couples separately completed surveys and interviews up to 6 times during the year after making a first appointment; clinical data were abstracted from medical records. Data were managed/analyzed in REDCap, NVivo, and Stata. Written transcripts were systematically coded via standard procedures for content analysis (>10% double coded). Through analysis of 414 interviews, we found that before an initial consultation with a RS most patients and their partners viewed gaining information as a key goal in meeting with a RS. Financial resources played an important role in shaping couples’ decision-making processes, and many respondents identified finances as an important constraint. Before their first appointment, 55% of respondents identified costs associated with trying to have a child as ‘‘quite a bit’’ or ‘‘very much’’ important to their decision-making, and that percentage increased to 64% after couples met with a RS. Couples able to purchase the care they desired generally moved relatively quickly both to consensus and to acting on their preferences. In contrast, couples whose finances were more constrained often delayed pursuing treatment that they otherwise agreed they would choose or worked together to identify a second-choice alternative that was financially feasible. Even as couples moved forward with one treatment path they often had a 2nd-choice alternative already in mind, as many were aware of the uncertainty associated with any given course of treatment. Finally, when looking back over the year, many supporting partners expressed regret at not being more involved along the way. Understanding how couples reach consensus concerning plans for reproductive treatment holds promise to improve quality of care and increase long-term decisional satisfaction for patients and their partners. When couples first meet with a RS, most have not already made any decisions and are seeking information and advice. A key factor shaping couples’ abilities to reach agreement and proceed with treatment is their financial resources. Those who cannot afford their ‘‘first choice’’ often need the opportunity to ruminate and may appreciate input from the RS on next-best alternatives.

Reproductive Ethics · ART Ethics

Human somatic cell nuclear transfer and reproductive cloning: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2016 Fertility and sterility

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.

Reproductive Ethics · ART Ethics

Oocyte or embryo donation to women of advanced reproductive age: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2016 Fertility and sterility

Advanced reproductive age (ARA) is a risk factor for female infertility, pregnancy loss, fetal anomalies, stillbirth, and obstetric complications. Oocyte donation reverses the age-related decline in implantation and birth rates of women in their 40s and 50s and restores pregnancy potential beyond menopause. However, obstetrical complications in older patients remain high, particularly related to operative delivery and hypertensive and cardiovascular risks. Physicians should perform a thorough medical evaluation designed to assess the physical fitness of a patient for pregnancy before deciding to attempt transfer of embryos to any woman of advanced reproductive age (>45 years). Embryo transfer should be strongly discouraged or denied to women of ARA with underlying conditions that increase or exacerbate obstetrical risks. Because of concerns related to the high-risk nature of pregnancy, as well as longevity, treatment of women over the age of 55 should generally be discouraged. This statement replaces the earlier ASRM Ethics Committee document of the same name, last published in 2013 (Fertil Steril 2013;100:337-40).

Reproductive Ethics · ART Ethics

Cross-border reproductive care: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2016 Fertility and sterility

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).

Reproductive Ethics · ART Ethics

Financial "risk-sharing" or refund programs in assisted reproduction: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2016 Fertility and sterility

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).

Reproductive Ethics · ART Ethics

Financial compensation of oocyte donors: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2016 Fertility and sterility

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).

Reproductive Ethics · ART Ethics

Disclosure of medical errors involving gametes and embryos: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2016 Fertility and sterility

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).

Reproductive Ethics · ART Ethics

Defining embryo donation: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2016 Fertility and sterility

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).

Guidelines by Issuing Body · United States Professional Societies

Provision of fertility services for women at increased risk of complications during fertility treatment or pregnancy: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2016 Fertility and sterility

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.

Guidelines by Issuing Body · United States Professional Societies

Moving innovation to practice: a committee opinion

Ethics Committee of American Society for Reproductive Medicine, 2015 Fertility and sterility

The introduction of new strategies, tests and procedures into clinical practice raises challenging ethical issues involving evaluation of evidence, balancing benefits and harms, supporting patient autonomy, avoiding conflict of interest, and promoting advances in health care. The purpose of this document is to assist reproductive health practitioners as they introduce new interventions into the clinical care that they provide to patients.

Guidelines by Clinical Area · Fertility and Infertility Guidelines

Human immunodeficiency virus (HIV) and infertility treatment: a committee opinion

Ethics Committee of American Society for Reproductive Medicine, 2015 Fertility and sterility

Human immunodeficiency virus (HIV) is a serious but manageable chronic disease that affects persons of reproductive age, many of whom express a desire for biologic parenthood. This document is a revision of the original document of the same name, last published in 2010 (Fertil Steril 2010;94:11-5).

Reproductive Ethics · ART Ethics

Disparities in access to effective treatment for infertility in the United States: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2015 Fertility and sterility

In the United States, economic, racial, ethnic, geographic, and other disparities exist in access to fertility treatment and in treatment outcomes. This opinion examines the factors that contribute to these disparities and proposes actions to address them.

Reproductive Ethics · ART Ethics

Access to fertility services by transgender persons: an Ethics Committee opinion

Ethics Committee of the American Society for Reproductive Medicine, 2015 Fertility and sterility

This statement explores the ethical considerations surrounding the provision of fertility services to transgender individuals and concludes that denial of access to fertility services is not justified.

Access and Coverage · Workforce and Availability

Racial disparities in access and cost for commonly prescribed infertility medications may contribute to disparities in pregnancy outcomes

Davis JB et al., 2011 Fertility and Sterility

To determine if disparities in cost and access to commonly prescribed infertility medications exist in predominately minority neighborhoods. A prospective phone survey of pharmacies in Bronx and Westchester counties of New York State was done to assess the availability and cost of commonly used infertility medications. Demographic data for each county was defined by U.S. Census Data. Pharmacies were categorized by ZIP code and the availability and cost for medication determined and compared to the racial composition of that ZIP code. 121 pharmacies were surveyed. Availability and cost of 15 medications commonly used to treat infertility were obtained. Data were stratified by racial demographics and analyzed with Fishers exact test, ANOVA, or Chi-square test for trend. Reduced availability of Clomiphene citrate (CC) was observed in the Bronx pharmacies (79 vs. 89%, P<0.01), an area populated by >80% blacks and Hispanics. Choriogonadotropin alpha (CGa) was not available in the Bronx (0 vs. 15%, P<0.01). There was also a significant decrease in the trend for the availability of both CC and CGa when the percentage of blacks increased from 10 to >40% (53 vs. 33%, P<0.01) compared to no change for increasing percentage of whites. In contrast the availability of CGa was highest in areas with > 80% white compared to areas with >40% black or Hispanic (15 vs. 0%, P<0.01). Interestingly as the percentage of the black population increased the cost of CGa significantly decreased ($133 ± 14 vs. $99 ± 10, P<0.01) and there was also a trend for reduced CC costs. Racial disparities in infertility outcomes are linked to delayed treatment and referral patterns or inadequate access or utilization of subspecialty care. These data suggest disparities in the availability of commonly used medications but not increased cost may adversely affect compliance and contribute to suboptimal treatment and delayed referral to subspecialist.