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

Financial "risk-sharing" fee structures in assisted reproduction programs charge patients a higher initial fee that includes multiple cycles but offers a partial or complete refund if treatment fails. This opinion of the American Society for Reproductive Medicine 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 2016.

Impact of in vitro fertilization state mandates for third party insurance coverage in the United States: a review and critical assessment.

The American Society for Reproductive Medicine estimates that fewer than a quarter of infertile couples have sufficient access to infertility care. Insurers in the United States (US) have long considered infertility to be a socially constructed condition, and thus in-vitro fertilization (IVF) an elective intervention. As a result, IVF is cost prohibitive for many patients in the US. State infertility insurance mandates are a crucial mechanism for expanding access to fertility care in the US in the absence of federal legislation. The first state insurance mandate for third party coverage of infertility services was passed by West Virginia in 1977, and Maryland passed the country's first IVF mandate in 1985. To date, twenty states have passed legislation requiring insurers to cover or offer coverage for the diagnosis and treatment of infertility. Ten states currently have "comprehensive" IVF mandates, meaning they require third party coverage for IVF with minimal restrictions to patient eligibility, exemptions, and lifetime limits. Several studies analyzing the impact of infertility and IVF mandates have been published in the past 20 years. In this review, we characterize and contextualize the existing evidence of the impact of state insurance mandates on access to infertility treatment, IVF practice patterns, and reproductive outcomes. Furthermore, we summarize the arguments in favor of insurance coverage for infertility care and assess the limitations of state insurance mandates as a strategy for increasing access to infertility treatment. State mandates play a key role in the promotion of evidence-based practices and represent an essential and impactful strategy for the advancement of gender equality and reproductive rights.

Reproductive medicine in the face of climate change: a call for prevention through leadership.

Climate change has led to a multitude of ecological disruptions and downstream reproductive health consequences that impair our reproductive capacity and, in turn, harm the health and survival of future generations. Atmospheric changes, driven by anthropogenic emissions, expose global populations to droughts, heat waves, rising sea levels, and extreme weather events-posing major threats to public health and exacerbating environmental health disparities. Existing evidence demonstrates the potential for climate-driven events to impact reproductive health outcomes, yet very few studies have explored this relationship. Recently, the American Society for Reproductive Medicine, the American College of Obstetricians and Gynecologists, and the International Federation of Gynecology and Obstetrics released position statements regarding reproductive health and environmental exposures. Unfortunately, such initiatives have yielded little action within the health care system. To address this stagnation, health care workers must meld research findings into actionable preventive medicine strategies and transition to a more action-oriented approach to address the climate crisis. The objective of this article is to elucidate the urgency of the climate crisis in relation to reproductive health and push the health care workers to recognize their intrinsic opportunity as leaders in climate action at local, state, national, and international levels. We call on health care organizations and health care workers to leverage their inherent positions as climate action leaders to increase climate resilience and mitigate climate-related adverse reproductive health outcomes.

An assessment of oncofertility content on reproductive endocrinology and infertility clinic websites.

PURPOSE: To assess oncofertility content on fertility clinic websites as indicated by eight relevant keywords. Additionally, we sought to describe the relationship between oncofertility content and five predetermined clinic characteristics. METHODS: We examined 381 fertility clinic websites that are members of the Society for Associated Reproductive Technology (SART). Extracted data included clinic location, practice type (private vs academic), size (cycles/year), type of NCI designated center (cancer center vs comprehensive cancer center), and distance from the nearest NCI center. Additionally, we documented whether the clinic was located in a state mandating reproductive and infertility services and/or included fertility preservation for "iatrogenic infertility" as reported by the American Society for Reproductive Medicine (ASRM). Data were summarized using descriptive statistics and compared using chi-squared or t-test as appropriate. RESULTS: Of the 381 fertility clinic websites analyzed, 322 (85%) contained at least one oncofertility-related keyword. Most frequently used terms included cancer (79%) and fertility preservation (78%), while less frequently used terms included suppression (9.4%) and shielding (5.0%). Practices that initiated ≥ 501 cycles per year were more likely to mention one of the oncofertility keywords (OR 1.2; 95% CI 1.1-1.3). The associations of oncofertility website content with practice type, state-mandated fertility insurance coverage, and distance from an NCI-designated cancer center were not statistically significant. Large clinic size was the only predictive factor for inclusion of oncofertility website content. Further studies are required to evaluate whether inclusion of oncofertility content on clinic websites impacts the use of these services by patients with cancer. CONCLUSION: This is the first study correlating availability of oncofertility content on SART fertility clinic websites with consideration of geographic proximity to NCI designated cancer centers. Large clinic size was the only predictive factor for inclusion of oncofertility website content.

Changing gender gap and practice patterns in reproductive endocrinology and infertility subspecialists in the United States: a Society for Reproductive Endocrinology and Infertility report.

OBJECTIVE: To identify changes in current practice patterns, salaries, and satisfaction by gender and by years in practice among board-certified reproductive endocrinology and infertility (REI) subspecialists in the United States. DESIGN: Cross-sectional web-based survey including 37 questions conducted by the Society for Reproductive Endocrinology and Infertility. SETTING: Not applicable. PATIENT(S): None. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): The primary outcome measures were total compensation and practice patterns compared by gender and the type of practice. The secondary outcomes included demographics, the number of in vitro fertilization cycles, surgeries performed, and the morale of survey respondents. RESULT(S): There were 370 respondents (48.4% women and 51.4% men). Compared with a similar survey conducted 6 years earlier, a 27% increase in the number of female respondents was observed in this survey. There was a marginally significant trend toward lower compensation for female than male REI subspecialists (17% lower, $472,807 vs. $571,969). The gap was seen for responders with ≥10 years' experience, which is also when there was the largest gap between private and academic practice (mean $820,997 vs, $391,600). Most (77%) felt positively about the current state of the reproductive endocrinology field, and >90% would choose the subspecialty again. CONCLUSION(S): There has been a substantial increase in the number of recent female REI subspecialists showing less disparity in compensation, and the gap appears to be closing. There is an increasing gap in compensation between private and academic practices with ≥5 years of experience. Reproductive endocrinology and infertility remains a high morale specialty.

Outcomes of embryo transfers performed by Reproductive Endocrinology and Infertility fellows vs. faculty: an 11-year retrospective review.

OBJECTIVE: To compare the clinical pregnancy rate (CPR) and live birth rate (LBR) of embryo transfer episodes (ETEs) performed by Reproductive Endocrinology and Infertility fellows vs. those of ETEs performed by faculty physicians. DESIGN: Retrospective cohort analysis. SETTING: Academic reproductive endocrinology and infertility practice. PATIENT(S): In total, 3,073 ETEs for 1,488 unique patients were performed by fellows or faculty physicians between January 2009 and January 2020. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Clinical pregnancy rate and LBR. RESULT(S): Fifteen fellows performed 1,225 (39.9%) of 3,073 ETEs after completing 30 mock transfers. On comparing outcomes among fellowship years (FY1, FY2, and FY3), CPR (44.1% vs. 43.2% vs. 45.7%, respectively, P = .83) and LBR (39.1% vs. 38.1% vs. 38.4%, respectively, P = .97) were not significantly different. Fellowship year 1 fellows' initial 30 ETEs vs. all the remaining FY1 ETEs had a significantly higher CPR (48.1% vs. 40.5%, respectively, P = .030) and LBR (45.4% vs. 34.3%, respectively, P = .001). There were no significant differences between faculty versus fellow ETEs in terms of CPR (43.0% vs. 45.0%, respectively, P = .30) or LBR (37.3% vs. 39.8%, respectively, P = .16), even after adjusting for patient age, body mass index, primary infertility diagnosis, autologous vs. donor oocyte, fresh vs. frozen embryo, number of embryos transferred, type of transfer catheter, and year of transfer (P = .32 for CPR, P = .22 for LBR). CONCLUSION(S): Appropriately trained FY1 fellows had success rates maintained throughout all FYs. There were no significant differences in clinical outcomes between fellow- and faculty-performed transfers. These data demonstrated that allowing fellows to perform live embryo transfers is not detrimental to clinical outcomes.

Teaming: learning, competing, and innovating in the world of reproductive medicine.

Healthcare teams must be deliberately cultivated to reach their full potential. Shifting focus from individual performance to a team's collective competence allows for targeted and evidence-based interventions that support teamwork and improve patient outcomes. We reviewed essential concepts drawn from team science and explored the practical applications of teaming. Reproductive endocrinology and infertility healthcare providers play a pivotal role by teaching, modeling, and fostering teaming attitudes and behaviors. Through teaming, we can maximize our teams' ability to learn, innovate, compete with other teams, and thrive in today's healthcare environment.

The African American experience in reproductive medicine: provider, patient, and pipeline perspectives.

The goal of this Views and Reviews is to let colleagues and leaders well versed in the African American experience in reproductive medicine address the problems of racism affecting our trainees and patients and, more significantly, propose solutions. The areas in reproductive medicine that will be explored from the African American perspective include the pipeline of providers, health disparities, and access to infertility treatment.

The pipeline problem: barriers to access of Black patients and providers in reproductive medicine.

The demographics of the United States are rapidly changing, and our health care workforce is not keeping pace with the population trends. The American Society for Reproductive Medicine (formerly The American Fertility Society) recognizes the need to increase diversity and is committed to promoting diversity across our membership and leadership as well as promoting equitable quality reproductive care to all patients. In the fall of 2020, the American Society for Reproductive Medicine convened a Diversity, Equity, and Inclusion Task Force to evaluate and make recommendations on the basis of findings to increase diversity to achieve equity and inclusion of reproductive and infertility services for all women. This article focuses on specific barriers that Black or African American patients face in accessing quality care and that provider's face in training and inclusion in reproductive medicine. Multiple publications have confirmed an improvement in health outcome when there is congruence between the patient and the provider. There is a stark contrast between the racial and ethnic diversity of our providers and other support personnel compared with that of our patients. Despite our best intent to minimize the effects of implicit and explicit bias, mistrust and misunderstandings when there is discordance between patients and providers negatively impacts care. To increase provider diversity, it is crucial that we prioritize pipeline programs that recruit and support underrepresented minority in medicine physicians. Specific recommendations are made to increase diversity in the pipeline to improve patient access to culturally competent quality reproductive medicine care with optimal outcomes.

Innovations in infertility: a comprehensive analysis of the ClinicalTrials.gov database.

OBJECTIVE: To characterize the interventional clinical trials in infertility and to assess whether trial location or industry sponsorship was associated with trial noncompletion. DESIGN: Retrospective review of trials registered with ClinicalTrials.gov. SETTING: None. PATIENT(S): None. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Descriptive statistics characterizing the attributes of the clinical trials including intervention type, topic, population, completion status, size, location, sponsor, and results. The effects of the sponsor and trial location on trial noncompletion were assessed via logistic regression. RESULT(S): In total, 505 trials initiated between 2010 and 2020 were included in our analysis. Drug interventions were the most commonly studied (45%); ovarian stimulation trials accounted for 27% of the studies. Live birth was tracked as an outcome by 20% of the studies; 3% of the trials included mental health outcomes. Few trials (15%) enrolled male participants. Only 11% of the trials reported results, and 4% of the trials reported the race or ethnicity of the participants. Most trials (82%) were conducted outside the United States. Overall, 18% of the trials were not completed, most often because of lack of accrual (47%). United States trials had over twice the odds of noncompletion in univariate analysis (odds ratio = 2.48, 95% confidence interval = [1.47, 4.17]); however, this relationship lost significance after adjusting for potential confounders (odds ratio = 0.95, 95% confidence interval = [0.42, 2.14]). Trial sponsorship was not associated with trial noncompletion. CONCLUSION(S): Infertility trials predominantly investigated drug interventions, particularly ovarian stimulation. Live birth was an infrequent outcome despite its relevance to patients. Clinical trials should aim to address the unmet needs in fertility care and be inclusive of underserved populations affected by infertility.

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

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

Disposition of unclaimed embryos: an Ethics Committee opinion.

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

Perceptions and lessons from web-based interviews for the reproductive endocrinology and infertility fellowship application cycle.

OBJECTIVE: To evaluate the experience and perceptions of reproductive endocrinology and infertility fellowship applicants and program directors (PDs) regarding the current and future use of web-based interviews (WBIs). DESIGN: Cross-sectional study. SETTING: Nationwide cohort. PATIENT(S): Reproductive endocrinology and infertility fellowship applicants and PDs participating in the 2020 application cycle. INTERVENTION(S): Anonymous survey sent to applicants and PDs. MAIN OUTCOME MEASURE(S): Descriptive study evaluating the experience and satisfaction of applicants and PDs with WBIs. RESULT(S): Forty-six percent of applicants and eligible PDs responded to our survey. Most applicants and PDs responded that WBIs were adequate for conveying a sense of a program's strengths, faculty, diversity, clinical training, and research opportunities, but less than half responded that WBIs were adequate in providing a sense of the program's clinical site and facilities. After WBIs, both applicants (73%) and PDs (86%) were able to rank with confidence. The cost of WBIs was significantly lower for both applicants (median: $100) and programs (median: $100) than the costs previously reported for in-person interviews. The applicants interviewed at more programs than they would have if the interviews were on-site, and Zoom was the highest rated platform used. Most applicants and PDs responded that WBIs were an adequate substitute, and that they should continue after the coronavirus disease 2019 pandemic. Furthermore, most of the PDs were planning to continue to use WBIs in some capacity. CONCLUSION(S): Both applicants and PDs had favorable experiences with and perceptions of WBIs, and most endorse the continued use of this interview modality. The findings of this study can help guide and optimize future WBI practices.

Oocyte cryopreservation versus ovarian tissue cryopreservation for adult female oncofertility patients: a cost-effectiveness study.

PURPOSE: In December 2019, the American Society for Reproductive Medicine designated ovarian tissue cryopreservation (OTC) as no longer experimental and an alternative to oocyte cryopreservation (OC) for women receiving gonadotoxic therapy. Anticipating increased use of OTC, we compare the cost-effectiveness of OC versus OTC for fertility preservation in oncofertility patients. METHODS: A cost-effectiveness model to compare OC versus OTC was built from a payer perspective. Costs and probabilities were derived from the literature. The primary outcome for effectiveness was the percentage of patients who achieved live birth. Strategies were compared using incremental cost-effectiveness ratios (ICER). All inputs were varied widely in sensitivity analyses. RESULTS: In the base case, the estimated cost for OC was $16,588 and for OTC $10,032, with 1.56% achieving live birth after OC, and 1.0% after OTC. OC was more costly but more effective than OTC, with an ICER of $1,163,954 per live birth. In sensitivity analyses, OC was less expensive than OTC if utilization was greater than 63%, cost of OC prior to chemotherapy was less than $8100, cost of laparoscopy was greater than $13,700, or standardized discounted costs were used. CONCLUSIONS: With current published prices and utilization, OC is more costly but more effective than OTC. OC becomes cost-saving with increased utilization, when cost of OC prior to chemotherapy is markedly low, cost of laparoscopy is high, or standardized discounted oncofertility pricing is assumed. We identify the critical thresholds of OC and OTC that should be met to deliver more cost-effective care for oncofertility patients.

Billing, coding, and practice management: a primer for today's reproductive medicine professional.

Despite years of recognition that many physicians are woefully unprepared to face challenges regarding the business of medicine, marginal progress has been made. In this piece, we aim to provide the contemporary reproductive medicine physician with an understanding of billing, coding, and, most importantly, cost containment for a typical fertility practice. It is critical for modern practices to not forego hard-earned revenue to insurance companies or not be aware of critical rules and regulations. While running a successful fertility practice requires good medical care, a profitable practice is necessary for overall long-term success. This article provides a brief history of medical insurance and billing, explains the process of updating billing codes, and reviews the revenue cycle, cost containment, and contract negotiations with insurance companies.

The need for business in reproductive medicine.

The business of medicine continues to be an area of growing importance, particularly in reproductive medicine. We provide a synthesis of salient concepts within the spectrum of business in medicine. The topics we review include finances and accounting; business operations as related to human resources, information technology (telemedicine), organizational governance, and practice models; insurance billing and contract negotiations; and the impact of health care policy on reproductive medicine.