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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.

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.

Congenital bilateral renal agenesis has been considered a uniformly fatal condition. However, the report of using serial amnioinfusions followed by the live birth in 2012 and ongoing survival of a child with bilateral renal agenesis has generated hope, but also considerable controversy over an array of complex clinical and ethical concerns. To assess the ethical concerns associated with using serial amnioinfusions for bilateral renal agenesis, we assembled a multidisciplinary group to map the ethical issues relevant to this novel intervention. The key ethical issues identified were related to 1) potential risks and benefits, 2) clinical care compared with innovation compared with research, 3) counseling of expectant parents, 4) consent, 5) outcome measures, 6) access and justice, 7) conflicts of interest, 8) effects on clinicians, 9) effects on institutions, and 10) long-term societal implications. These ethical issues should be addressed in conjunction with systematic efforts to examine whether this intervention is safe and effective. Future work should capture the experiences of expectant parents, women who undergo serial amnioinfusions, those born with bilateral renal agenesis and their families as well as clinicians confronted with making difficult choices related to it.

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).

Within the realm of bioethics, the construction of pregnancy classically has focused on principle-based ethics, essentially separating maternal and fetal interests. Respect for maternal autonomy becomes distinct from an obligation of fetal beneficence, placing practitioners in complicated ethical situations when the goals of pregnant women may be at odds with the best health interests of the fetus as defined by both professional groups and society in general. As a result, clinical care is framed by an ethical "maternal-fetal conflict," with important downstream legal and policy consequences for the well-being of pregnant women. Developments in the social sciences highlight the value of attending to the biosocial realm that a pregnant woman inhabits rather than relating to her and to her fetus as discrete entities. By understanding the needs, concerns, and context within which a woman lives, clinicians can practice an ethics of accompaniment. With a focus on an ethics of accompaniment, assumptions about the maternal moral responsibility to fetal health made by practitioners and society in general can directly affect not only clinical care, but also the way policy surrounding reproductive health is constructed and implemented.

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).

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).

Objective To determine whether there are ethnic differences in the proportion of IVF patients donating excess cryopreserved embryos for use in research. Design Retrospective. Setting University clinic. Patient(s) Four hundred consecutive patients undergoing IVF. Intervention(s) None. Main Outcome Measure(s) Embryo disposition plan reported on the cryopreservation consent form (disposal, donation for research, or donation for therapeutic use). Result(s) Compared with Europeans or Asians born in the U.S., Asians born outside the U.S. were less likely to opt to donate excess embryos. Research donation was highly associated with interest in participation in clinical research. Conclusion(s) Decreased donation of excess embryos for research among Asians born outside the U.S. may relate to religious, sociocultural, language, or other undescribed factors. Targeted educational strategies may be critical to the development of a diverse pool of embryos available for research.

The use of iPSCs and tetraploid complementation for human reproductive cloning would raise profound ethical objections. Professional standards and laws that ban human reproductive cloning by somatic cell nuclear transfer should be revised to also forbid it by other methods, such as iPSCs via tetraploid complementation.

Objective To describe fertility patients' preferences for disposition of cryopreserved embryos and determine factors important to these preferences. Design Cross-sectional survey conducted between June 2006 and July 2007. Setting Nine geographically diverse U.S. fertility clinics. Patient(s) 1020 fertility patients with cryopreserved embryos. Intervention(s) Self-administered questionnaire. Main Outcome Measure(s) Likelihood of selecting each of five conventional embryo disposition options: store for reproduction, thaw and discard, donate to another couple, freeze indefinitely, and donate for research; likelihood of selecting each of two alternative options identified in previous research: placement of embryos in the woman's body at an infertile time, or a disposal ceremony; importance of each of 26 considerations to disposition decisions; and views on the embryo's moral status. Result(s) We found that 54% of respondents with cryopreserved embryos were very likely to use them for reproduction, 21% were very likely to donate for research, 7% or fewer were very likely to choose any other option. Respondents who ascribed high importance to concerns about the health or well-being of the embryo, fetus, or future child were more likely to thaw and discard embryos or freeze them indefinitely. Conclusion(s) Fertility patients frequently prefer disposition options that are not available to them or find the available options unacceptable. Restructuring and standardizing the informed consent process and ensuring availability of all disposition options may benefit patients, facilitate disposition decisions, and address problems of long-term storage.

Stem cell researchers commonly use human pluripotent stem cell lines derived by other investigators. Researchers may use lines derived elsewhere, provided that their derivation met consensus core standards. Some types of derivation raise heightened levels of ethical concern and require greater scrutiny. To maintain public trust, research institutions need to justify why they allow researchers to use lines whose derivation would not have been permitted locally.

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).

OBJECTIVE To assess the effect of abnormal uterine bleeding and pelvic pain and pressure on health-related quality of life and sexual functioning and assess treatment satisfaction. METHODS This is a cross-sectional study of 1,493 sociodemographically diverse women who were seeking care for noncancerous pelvic problems and who had not undergone hysterectomy. Participants were asked about symptoms, attitudes, health-related quality of life, sexual functioning, and treatment satisfaction. Preference for current health was measured using the time tradeoff metric, which asked respondents to estimate the number of years of life they would be willing to trade off to not have a uterine condition. Multivariable logistic regression was used to identify determinants of treatment satisfaction. RESULTS Most (82.7%) participants reported a complete lack of or only partial symptom resolution, and 42.3% reported that their pelvic problems interfered with their ability to have and enjoy sex. Mean Short Form-12 Physical (43-49) and Mental (41-44) Component Summary scores were substantially lower than population norms for women aged 40-49 years. Mean current health time tradeoff scores ranged from 0.78 to 0.88. Satisfaction with Western medicines ranged from 31.3% (progestin intrauterine device) to 58.2% (opiates) and with uterine-preserving surgery from 20.0% (dilation and curettage) to 51.0% (myomectomy); 27.7 % of the women who used acupuncture were satisfied. Participants with lower educational attainment, greater symptom resolution, and less interference of pelvic problems with sex were more likely to be satisfied. CONCLUSION Noncancerous pelvic problems are associated with serious decrements in health-related quality of life and sexual functioning and low rates of treatment satisfaction. LEVEL OF EVIDENCE II.

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 This study was undertaken to describe abortion attitudes in a diverse cohort of pregnant women enrolled in prenatal care. Study design A cross-sectional interview study of 1082 demographically diverse gravid women enrolled in prenatal care at less than 20 weeks' gestation was performed. Results Most participants (92%) supported abortion availability. Half (50%) who were willing to consider an abortion would do so only in the first trimester. Among the gravid women willing to consider an abortion in the first or second trimester, 84% would do so after rape/incest or if their life was endangered and 76% would if their fetus had Down syndrome. Gravid women considering abortion were more likely to be white, older, have had a previous abortion, and to express distrust in the health care system. Women who would not consider abortion were more likely to be multiparous, married/living with partner, and to express greater faith and fatalism about their pregnancy outcome. Conclusion Although most pregnant women enrolled in prenatal care support abortion availability, about half would only consider a first-trimester procedure. These findings underscore the need for early prenatal genetic counseling, screening, and testing.

Objectives To describe women's preferences for prenatal testing outcomes and to explore their association with sociodemographic characteristics and attitudes. Methods We conducted a cross-sectional study of 584 racially/ethnically and socioeconomically diverse pregnant women aged 16 to 47 years recruited from 23 San Francisco Bay Area practices. We assessed preferences for 12 potential prenatal testing outcomes using the time trade-off metric for all outcomes and the standard gamble metric for two outcomes. Preferences were calculated on a scale of 0 (death) to 1 (perfect health). Participants also completed a sociodemographic and attitude survey. Results Highest preference scores were assigned to outcomes resulting in the birth of a chromosomally normal infant (mean = 0.91–0.93; median = 0.99–1.00). Lower scores were obtained for outcomes involving pregnancy loss (mean = 0.69–0.87; median = 0.76–0.92), which were correlated with attitudes regarding miscarriage, pregnancy termination, and Down syndrome. The lowest scores were assigned to Down syndrome–affected births (mean = 0.67–0.69; median = 0.73–0.75), which also were correlated with attitudes toward Down syndrome. We did not find a statistically significant relationship between participants' preference scores and age. Conclusion Preferences for prenatal testing outcomes vary according to the pregnant women's underlying attitudes about pregnancy loss and Down syndrome, and not according to her age. Current age/risk-based guidelines should account for individual variation in patient preferences. Copyright © 2004 John Wiley & Sons, Ltd.

BACKGROUND: Important clinical, social, and ethical questions are associated with the evaluation and use of surgical approaches aimed at correcting fetal anatomic abnormalities. In particular, the expansion of maternal-fetal surgery to ameliorate nonlethal fetal conditions has intensified the need to address issues about the adequacy of technology assessment and the safety of those who undergo these novel procedures. APPROACH: After discussions at a multidisciplinary conference, we reviewed the development and current practices of maternal-fetal surgery and analyzed the relevant ethical issues concerning the use of maternal-fetal surgery for nonlethal conditions, focusing on the correction of myelomeningocele. FINDINGS: Characterizing nonvalidated maternal-fetal surgery procedures as “innovative therapy” blurs the boundaries between research and therapy and creates uncertainty about the obligations of clinicians and researchers. Further, maternal-fetal surgery raises ethical issues related to maternal risks and benefits, informed consent, distinguishing lethal from nonlethal conditions, withholding unproven treatments, entrepreneurship, and prioritization. RECOMMENDATIONS: To help ensure that maternal-fetal surgery will be studied and eventually applied in a scientifically and ethically sound manner, we offer several recommendations. First, innovation in maternal-fetal surgery should be conducted and evaluated as research. Second, women must be considered research subjects in these trials. Third, the informed consent process must ensure adequate comprehension and genuine voluntariness in those considering participation. Fourth, discriminatory and fearful attitudes toward individuals with disabilities should be addressed explicitly prior to making a decision to proceed with maternal-fetal surgery in an attempt to correct such disabilities. Fifth, maternal-fetal surgery should not be performed for cosmetic indications unless and until there is reliable evidence that maternal-fetal surgery can be performed safely and that long-term side effects on women and their offspring are minimal. Sixth, centers of excellence should be established for conducting research and providing maternal-fetal surgery. Seventh, funding for research on maternal-fetal surgery should be considered in the context of societal needs.

Objective: We sought to determine the reasons for obstetric and gynecologic patients' acceptance or refusal of medical student participation in their outpatient care. Study Design: A descriptive and analytic cross-sectional study of 180 patients at the University of California, San Francisco, was done to identify factors involved in patient acceptance or refusal of medical student participation in their outpatient obstetric-gynecologic visit. Responses were analyzed by Cochran-Mantel-Haenszel tests for rank order tests of factors involved in the decision to accept or decline medical student participation and χ 2 or Fisher exact tests for comparison of data among different groups. Results: Reasons for accepting medical student involvement included the desire to contribute to the training of future physicians and the desire for the highest standard of care. Reasons for refusing medical student involvement included the protection of patient privacy and the low comfort level with the examination. The acceptance rate for medical students during the obstetric visits was 89.1%, and that during the gynecologic visits was 81.4%. Conclusion: Private faculty patients, as well as Medicaid patients, have a high acceptance of both male and female medical students in the obstetric-gynecologic outpatient setting. (Am J Obstet Gynecol 2000;182:1429-32.)

Women aged 35 or older who wish to undergo prenatal diagnosis for chromosomal disorders are typically offered a choice between chorionic villus sampling or amniocentesis. These two tests are performed at different times and impose differing miscarriage risks. In deciding which test to use, therefore, women need to consider both short-term consequences (e.g. timing of pregnancy loss, should it occur) and long-term consequences (e.g. whether a pregnancy loss is followed by a future birth). We examined how women seeking prenatal diagnostic services value the outcomes of testing. We conducted a cross-sectional study of 72 women seeking genetic counselling at the University of California at San Francisco or Kaiser San Francisco. We measured preferences for outcomes (utilities) of prenatal diagnosis using the standard gamble metric. We also assessed demographics and attitudes via questionnaire. We observed no differences in mean utilities assigned to first- versus second-trimester pregnancy losses with similar long-term sequelae. Utilities for losses followed by future birth, however, were significantly higher than utilities for losses without future birth (range 0.91 to 0.93 versus 0.84 to 0.86, p

The discussion of ethical issues in managed care can be focused on two general areas. The first of these is the impact of the shift toward managed care on the fiduciary relationship between health care professional and patient, including the issue of trust, the potential for conflict of interest, and the impact of cost-saving strategies on the clinician's ability to address a patient's health care needs. The second is the attention to justice that managed care demands. Health care professionals must take issues in both areas into account, attempting to balance obligations to individual patients with obligations to patients collectively. Strategies for doing so are discussed.

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).

Background In 2010, the NIH and ACOG recommended increasing women’s access to trial of labor after cesarean (TOLAC). This study explored access to TOLAC in California, change in access since 2007 and 2010, and characteristics of TOLAC and non-TOLAC hospitals. Methods Between November 2011 and June 2012, charge nurses at all civilian California birth hospitals were surveyed about hospitals’ TOLAC availability and requirements for providers. VBAC rates were obtained from the California Office of Statewide Health Planning and Development (OSHPD). Distance between hospitals was calculated using OSHPD geocoding. Results All 243 birth hospitals that were contacted participated. In 2010, among the 56% TOLAC hospitals, the median VBAC rate among TOLAC hospitals was 10.8% (range 0-37.3%). The most cited reason for low VBAC rates was physician unwillingness to perform them, especially due to the requirement to be continually present during labor. TOLAC hospitals were more likely to be larger hospitals in urban communities with obstetrical residency training. However, there were six (11.3%) residency programs in non-TOLAC hospitals and 5 (13.5%) rural hospitals offering TOLAC. The majority of TOLAC hospitals had 24/7 anesthesia coverage and required the obstetrician to be continually present if a TOLAC patient was admitted; 17 (12.2%) allowed personnel to be 15-30 minutes away. TOLAC eligibility criteria included one prior cesarean (32.4%), spontaneous labor (52.5%), continuous fetal monitoring and intravenous access (99.3%), and epidural analgesia (19.4%). The mean distance from a non-TOLAC to a TOLAC hospital was 37 mi. with 25% of non-TOLAC hospitals more than 51 mi. from the closest TOLAC hospital.In 2012, 139 hospitals (57.2%) offered TOLAC, 16.6% fewer than in 2007. Since 2010, five hospitals started and four stopped offering TOLAC, a net gain of one hospital offering TOLAC with three more considering it. Only two hospitals cited change in ACOG guidelines as a reason for the change. Conclusions Despite the 2010 NIH and ACOG recommendations encouraging greater access to TOLAC, 44% of California hospitals do not allow TOLAC. Of the 56% allowing TOLAC, 10.8% report fewer than 3% VBAC births. Thus, national recommendations encouraging greater access to TOLAC had a minor effect in California.

Objective To determine whether use of chorionic villus sampling and amniocentesis varies by racial-ethnic group and, if so, whether this variation is reflected in the prevalence of Down syndrome-affected births to women age 35 and older, the ages at which prenatal diagnosis is offered currently. Methods Medical charts of 238 women 35 years of age and older presenting for care at the University of California at San Francisco by 20 gestational weeks in 1993 and 1994 were reviewed to assess prenatal diagnostic test use. The prevalence of Down syndrome-affected births in California during 1983–1991 was obtained from the Birth Defects Monitoring Program. Results Latinas and African-American women were much less likely to undergo prenatal diagnosis than were whites and Asians. Odds ratios (OR) and 95% confidence intervals (CI, with white women serving as the reference group, were as follows: Asians 1.16 (0.57–2.36), Latinas 0.19 (0.08–0.43), and African-Americans 0.19 (0.07–0.49). Trends persisted, at diminished magnitude, after adjustment for socioeconomic characteristics: OR for Asians 1.77 (0.78–3.98), Latinas 0.28 (0.09–0.83), and African-Americans 0.33 (0.10–1.10). Non-white women age 35 and older were significantly more likely than white women to give birth to a Down syndrome-affected infant: risk ratios for Asians 1.81 (1.61–2.03), Latinas 3.00 (2.74–3.28), and African-Americans 1.86 (1.63–2.11). Conclusion Racial-ethnic differences exist in prenatal diagnostic test use and associated outcomes in women age 35 and older. Socioeconomic factors are partially responsible; patient education and preferences may play a role.

The techniques of prenatal genetic diagnosis are being used with increasing frequency in the provision of prenatal care. One aim of such testing is to benefit pregnant women. Inadequate data exist, however, to indicate whether testing provides benefits for or imposes burdens upon the women involved. The influence of testing on anxiety during pregnancy, on a woman's sense of control over the progress and outcome of pregnancy, and on a woman's relationships with her partner and future child are all of concern. Investigation of these questions should be integral to studies undertaken to assess prenatal genetic testing.

Background Comprising over 600,000 patients per year, hysterectomy is the most common nonobstetrical operation performed in US women. Little is known about the natural history of the noncancerous uterine conditions leading to hysterectomy. We followed a prospective cohort of women with common pelvic problems to determine whether simple clinical characteristics could predict a subsequent hysterectomy. Study Design We recruited 762 women seeking care for abnormal uterine bleeding, chronic pelvic pain, or symptomatic uterine fibroids and ascertained their hysterectomy status during 4 years of surveillance. We collected baseline patient-reported sociodemographic and clinical data and fit Cox models to predict the effects of covariates on hysterectomy across patient age. Results There were 99 hysterectomies, resulting in 0.044 hysterectomies per person-year of observation and a 13.5% cumulative hysterectomy rate. Hysterectomy was independently predicted by multiple pelvic symptoms or symptomatic fibroids (hazard ratio [HR], 1.97; 95% CI, 1.18−3.28), previous use of a gonadotropin-releasing hormone agonist (HR, 2.54; 95% CI, 1.53−4.24), and an absence of symptom resolution (HR, 2.24; 95% CI, 1.46−3.44). Survival curves plotted for subgroups with combinations of these predictors showed an escalating risk of hysterectomy with each additional risk factor. Predicted hysterectomy rates ranged from 20%, if all 3 predictors were absent, to 95%, if all 3 were present. Conclusions For women with common pelvic problems, three easily measured clinical characteristics (symptom combination, degree of resolution, and earlier use of a gonadotropin-releasing hormone agonist) predict the likelihood of subsequent hysterectomy and can be used to inform counseling about the likely success of alternative treatments.

To identify predictors of prenatal genetic testing decisions and explore whether racial or ethnic and socioeconomic differences are explained by knowledge, attitudes, and preferences.This was a prospective cohort study of 827 English-, Spanish-, or Chinese-speaking pregnant women presenting for care by 20 weeks of gestation at 1 of 23 San Francisco Bay-area obstetrics clinics and practices. Our primary outcome measure for women aged less than 35 years was any prenatal genetic testing use compared with none, and for women aged 35 years or older, prenatal testing strategy (no testing, screening test first, straight to invasive diagnostic testing). Baseline questionnaires were completed before any prenatal test use; test use was assessed after 30 gestational weeks.Among women aged less than 35 years, no racial or ethnic differences in test use emerged. Multivariable analyses yielded three testing predictors: prenatal care site (P = .024), inclination to terminate pregnancy of a Down-syndrome-affected fetus (odds ratio 2.94, P = .002) and belief that modern medicine interferes too much in pregnancy (odds ratio .85, P = .036). Among women aged 35 years or older, observed racial or ethnic and socioeconomic differences in testing strategy were mediated by faith and fatalism, value of testing information, and perceived miscarriage risk. Multivariable predictors of testing strategy included these 3 mediators (P = .035, P.001, P = .037, respectively) and health care system distrust (P = .045). A total of 29.5% of screen-positive women declined amniocentesis; 6.6% of women screening negative underwent amniocentesis.Racial or ethnic and socioeconomic differences in prenatal testing strategy are mediated by risk perception and attitudes. Screening is not the best choice for many women. Optimal prenatal testing counseling requires clarification of risks and consideration of key attitudes and preferences regarding the possible sequence of events after testing decisions.

Scientific progress in human embryonic stem cell (hESC) research and increased funding make it imperative to look ahead to the ethical issues generated by the expected use of hESCs for transplantation. Several issues should be addressed now, even though phase I clinical trials of hESC transplantation are still in the future. To minimize the risk of hESC transplantation, donors of materials used to derive hESC lines will need to be recontacted to update their medical history and screening. Because of privacy concerns, such recontact needs to be discussed and agreed to at the time of donation, before new hESC lines are derived. Informed consent for phase I clinical trials of hESC transplantation also raises ethical concerns. In previous phase I trials of highly innovative interventions, allegations that trial participants had not really understood the risk and benefits caused delays in subsequent trials. Thus, researchers should consider what information needs to be discussed during the consent process for hESC clinical trials and how to verify that participants have a realistic understanding of the study. Lack of attention to the special ethical concerns raised by clinical trials of hESC transplantation and their implications for the derivation of new hESC lines may undermine or delay progress toward stem cell therapies.

Prenatal testing for Down syndrome and neural tube defects has become routine, and testing for other genetic conditions is becoming commonplace. Counseling about these tests involves a discussion of risk information, so pregnant women and their partners can use the information effectively when they make choices about testing. Discussing risk can be challenging, as many individuals, particularly those of lower literacy, have a poor understanding of the numerical concept of risk. Furthermore, whether risk is comprehended accurately or not, it is interpreted by patients in light of their existing knowledge and past experiences. Strategies available to optimize understanding of risk include communication of risk figures as frequencies rather than as probabilities or percentages and explicit discussion of a woman's preconceptions about her risk and about the condition being tested for.

Research with human oocytes, embryos, and additional embryonic stem cell lines is needed to address important scientific questions and to fulfill the promise of stem cell transplantation for degenerative diseases. Proponents need to develop guidelines for the appropriate conduct of embryonic stem cell research. Such guidelines will help build public trust and acceptance for this research. In this article, we offer recommendations for informed consent, discussing who should give consent, what the consent process should cover, when consent should be obtained, and who should obtain consent. Consent to use embryos for research should be obtained from oocyte and sperm donors as well as from the woman or couple undergoing infertility treatment. The consent discussion must cover information that donors need to know to make an informed decision about various types of research. Donations for research should be discussed at the initiation of advanced infertility treatment and reconfirmed if possible at the time of actual donation for research. Treating assisted reproduction technology physicians can help with the consent process, provided that they are not involved in the research.

As research with human embryos and embryonic stem cells proceeds, the authors of this Policy Forum argue that all donors of biological materials should give informed consent, including oocyte and sperm donors. Informed consent is particularly important because of the diverse opinions and strong emotions that surround such research. Some gamete donors who are willing to help women and couples bear children may object to the use of their genetic materials for certain types of research.

The purpose of this cross-sectional study of 999 socioeconomically and racially/ethnically diverse pregnant women was to explore prenatal genetic testing attitudes and beliefs and the role of external influences. Surveys in English, Spanish, and Chinese included questions regarding the value of testing, pregnancy, and motherhood; the acceptability of Down syndrome in the subject's community; and the role of social and cultural influences in prenatal testing decisions. We analyzed racial/ethnic differences in all attitudinal and external influence variables, controlling for age, relationship status, and socioeconomic status. We found statistically significant racial/ethnic group differences in familiarity with an individual with Down syndrome and in 10 of 12 attitude, belief, and external influence variables, even after controlling for other sociodemographic characteristics. We also observed substantial variation within racial/ethnic groups for each of these measures. Despite the statistically significant group differences observed, R2 values for all multivariate models were modest and response distributions overlapped substantially. Social and familial contexts for prenatal testing decisions differ among racial/ethnic groups even after accounting for age, marital status, and other socioeconomic factors. However, substantial variation within groups and overlap between groups suggest that racial/ethnic differences play a small role in the social and familial context of prenatal genetic testing decisions. © 2002 Wiley-Liss, Inc.

This report suggests an alternative for dealing with the diagnostic dilemma of differentiating an ovarian pregnancy from a ruptured CL cyst and suggests a conservative management approach that will possibly minimize adhesion formation and optimize future fertility. This new approach is based on a single case reported here, and therefore needs further verification. However, use of this revised set of diagnostic criteria, combined with the judicious use of MTX, may be an alternative therapy for selected ovarian pregnancies.

Objective: To determine how pregnant women of varying ages, races, ethnicities, and socioeconomic backgrounds value procedure-related miscarriage and Down–syndrome-affected birth. Methods: We studied cross-sectionally 534 sociodemographically diverse pregnant women who sought care at obstetric clinics and practices throughout the San Francisco Bay area. Preferences for procedure-related miscarriage and the birth of an infant affected by Down syndrome were assessed using the time trade-off and standard gamble metrics. Because current guidelines assume that procedure-related miscarriage and Down syndrome–affected birth are valued equally, we calculated the difference in preference scores for those two outcomes. We also collected detailed information on demographics, attitudes, and beliefs. Results: On average, procedure-related miscarriage was preferable to Down syndrome–affected birth, as evidenced by positive differences in preference scores for them (time trade-off difference: mean = 0.09, median = 0.06; standard gamble difference: mean = 0.11, median = 0.02; P < .001 for both, one-sample sign test). There was substantial subject-to-subject variation in preferences that correlated strongly with attitudes about miscarriage, Down syndrome, and diagnostic testing. Conclusion: Pregnant women tend to find the prospect of a Down syndrome–affected birth more burdensome than a procedure-related miscarriage, calling into question the equal risk threshold for prenatal diagnosis. Individual preferences for those outcomes varied profoundly. Current guidelines do not appropriately consider individual preferences in lower-risk women, and the process for developing prenatal testing guidelines should be reconsidered to better reflect individual values.

We conducted a study to elucidate factors influencing women's decisions regarding prenatal genetic screening for and diagnosis of chromosomal disorders and to learn about their experiences with these tests and with the medical system. Using focus group interviews and questionnaire assessments, we obtained detailed impressions of a diverse group of 75 pregnant women. Participants varied with respect to race/ethnicity, religious background, and reproductive history, as well as in their decisions about use of prenatal screening and diagnostic testing. Substantial variation surfaced in attitudes toward testing. Factors influencing women's views included available resources, feelings about having a child with Down syndrome, moral beliefs, family and social influences, perceptions of one's own health, the difficulty of becoming pregnant, and willingness to put the fetus at elevated miscarriage risk. Such findings indicate that age-based policies regarding access to prenatal diagnoses that, among other reasons, are based on the balance of risks between bearing a child with a chromosomal abnormality versus procedure-related loss are incompatible with the range of concerns that women bring to this decision and the weight individual women may assign to the outcomes.