Universal SARS-CoV-2 polymerase chain reaction screening and assisted reproductive technology in a coronavirus disease 2019 pandemic epicenter: screening and cycle outcomes from a New York City fertility center.

OBJECTIVE: To evaluate the prevalence of coronavirus disease 2019 (COVID-19) and efficacy of a universal screening program in patients undergoing controlled ovarian stimulation (COS). DESIGN: Single-center retrospective cohort study. SETTING: Academic fertility center in an epicenter of the COVID-19 pandemic. PATIENT(S): All patients undergoing COS from June 17, 2019, to February 28, 2021. INTERVENTION(S): Universal COVID-19 screening starting June 17, 2020, with SARS-CoV-2 polymerase chain reaction testing within 5 days of oocyte retrieval, patient-reported symptom screening, and temperature monitoring. MAIN OUTCOMES MEASURE(S): The primary outcome was the number of positive COVID-19 cases in patients undergoing COS cycles. The secondary outcomes were cycle outcomes compared with before COVID-19 COS cycles, adverse outcomes in COVID-canceled cycles, and center-specific COVID-19 detection rates compared with New York City cases. RESULT(S): From June 17, 2020, to February 28, 2021, 1,696 COS cycles were initiated with only seven positive COVID-19 cases for an overall positivity rate of 0.4%. When compared with before COVID cycles from June 17, 2019, to February 28, 2020, the volume of COS cycles were higher, while the overall cycle cancelation rate was lower during COVID-19. Cycle outcomes including oocyte yield and blast utilization rates were unchanged from pre-COVID cycles. Cases of COVID-19, while very low, occurred more frequently during surges in New York City rates. CONCLUSION(S): Assisted reproductive technology can be performed during the COVID-19 pandemic utilizing frequent universal screening and safe practices with low SARS-CoV-2 positivity, low cycle cancelation rates, and positive patient outcomes.

"Add-Ons" for Assisted Reproductive Technology: Do Patients Get Honest Information from Fertility Clinics' Websites?

"Add-on" procedures are actively promoted on some fertility clinic websites as proven means to improve IVF success rates, especially for couples with repeated implantation/IVF failures. However, the actual contribution of these interventions to live birth rates remains inconclusive. At present, little is known about the type and quality of the information provided on the IVF clinics' websites regarding the merits of "add-ons." A systematic evaluation of the quality of information on "add-on" procedures in fertility clinic websites was performed using 10-criteria structured questionnaire. We included English language websites that presented in the Google.com search engine after typing the following key-words:"endometrial scratching"(ES), "intralipid infusions"(ILI), "assisted hatching"(AHA), "PGT-A," or "PGS". In total, 254 websites were evaluated. In most cases, an accurate description of the "add-on" procedures was provided (78.8%). However, only a minority (12%) reported their undetermined effectiveness. The use of PGT-A was more often encouraged (52.8%) than ES (23.6%) and AHA (16%). The cost was infrequently presented (6.9%). Scientific references were only rarely provided for ILI, versus 12.7% for ES, 4.0% for AHA, and 5.6% for PGT-A. The information entry date was often missing. None of the websites reported the clinic's pregnancy-rate following the "add-on" procedures. Information on "add-ons" available to patients from IVF clinic websites is often inaccurate. This could perpetuate false myths among infertile patients about these procedures and raises concern regarding possible commercial bias. It is imperative that IVF clinic websites will better communicate the associated risks and uncertainties of "add-ons" to prospective patients.

We are here for you: infertility clinic communication during the first wave of the COVID-19 pandemic.

PURPOSE: To study how SART-member fertility clinics communicated via clinic websites during the first wave of the COVID-19 pandemic following publication of ASRM COVID-19 Task Force recommendations. METHODS: SART-member fertility clinic websites were systematically surveyed for the presence of an REI-specific COVID-19 message (REI-CM) and analyzed for their adherence to ASRM guidance. RESULTS: Of the 381 active clinic websites, 249 (65.3%) had REI-specific COVID messaging. The presence of REI-CM was more common in private than in academic practices (73% vs 38%, p < 0.001) and with increasing practice volume: 38% of clinics with < 200 annual cycles vs 91% of clinics with > 1000 cycles (p < 0.001). Adherence to ASRM guidance was more common in academic than in private practices (54% vs 31%, p = 0.02). Additionally, 9% of REI-CM (n = 23) announced continued treatment regardless of a patient's clinical urgency. This messaging was more common in groups doing > 1000 cycles a year (18%, p = 0.009). Clinics treating all-comers were less likely to cite ASRM than other clinics (41% vs 62%, p = 0.045). However, 75% (n = 14) cited COVID-19 guidance from WHO, CDC, and state and local governments. CONCLUSIONS: Clinic response to ASRM recommendations during the first wave of COVID-19 pandemic was heterogeneous. Although academic practices were more likely to follow ASRM guidance, there was a lower extent of patient-facing messaging among academic practices than private clinics. In event of further escalations of this and future pandemics, clinics can learn from experiences to provide clear messaging to patients.

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

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

Minimum standards for practices offering assisted reproductive technologies: a committee opinion.

This document is designed to provide a framework for assisted reproductive technology (ART) programs that meet or exceed the requirements suggested by the Centers for Disease Control and Prevention for certification of ART laboratories. This document replaces the document "Revised Minimum Standards for Practices Offering Assisted Reproductive Technologies: A Committee Opinion" published in 2019.

Society for Assisted Reproductive Technology advertising guidelines: How are member clinics doing?

OBJECTIVE: To examine whether Society for Assisted Reproductive Technology (SART) member in vitro fertilization (IVF) centers adhere to the Society's new advertising policy, updated in January 2018, and evaluate other services advertised by region, insurance mandate and university affiliation status. Historically, a large percentage of IVF clinics have not adhered to SART guidelines for IVF clinic website advertising and have had variability in how financial incentives and other noncore fertility services are advertised. DESIGN: Cross-sectional study. SETTING: Not applicable. PATIENT(S): None. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Adherence of SART participating websites to objective criteria from the 2018 SART advertising guidelines. RESULT(S): All 361 SART participating clinic websites were evaluated. Approximately one third of clinics reported success rate statistics directly on their websites, but only 52.6% of those clinics reported current statistics. Similarly, only 67.5% of SART member clinics included the required disclaimer statement regarding their outcome statistics. Only 10.5% of websites were wholly compliant with SART guidelines regarding presentation of supplemental data. There were no significant differences between academic and nonacademic centers, programs in mandated versus nonmandated states, or East versus West Coast clinics in any of these areas. CONCLUSION(S): Many of the SART member websites failed to adhere to core guidelines surrounding reporting IVF clinic success rates. Consideration for additional education and streamlining as well as simplifying success rate advertising guidelines is recommended.

Top 10 priorities for future infertility research: an international consensus development study.

STUDY QUESTION: Can the priorities for future research in infertility be identified? SUMMARY ANSWER: The top 10 research priorities for the four areas of male infertility, female and unexplained infertility, medically assisted reproduction, and ethics, access, and organization of care for people with fertility problems were identified. WHAT IS KNOWN ALREADY: Many fundamental questions regarding the prevention, management, and consequences of infertility remain unanswered. This is a barrier to improving the care received by those people with fertility problems. STUDY DESIGN, SIZE, DURATION: Potential research questions were collated from an initial international survey, a systematic review of clinical practice guidelines, and Cochrane systematic reviews. A rationalized list of confirmed research uncertainties was prioritized in an interim international survey. Prioritized research uncertainties were discussed during a consensus development meeting. Using a formal consensus development method, the modified nominal group technique, diverse stakeholders identified the top 10 research priorities for each of the categories male infertility, female and unexplained infertility, medically assisted reproduction, and ethics, access, and organization of care. PARTICIPANTS/MATERIALS, SETTING, METHODS: Healthcare professionals, people with fertility problems, and others (healthcare funders, healthcare providers, healthcare regulators, research funding bodies and researchers) were brought together in an open and transparent process using formal consensus methods advocated by the James Lind Alliance. MAIN RESULTS AND THE ROLE OF CHANCE: The initial survey was completed by 388 participants from 40 countries, and 423 potential research questions were submitted. Fourteen clinical practice guidelines and 162 Cochrane systematic reviews identified a further 236 potential research questions. A rationalized list of 231 confirmed research uncertainties were entered into an interim prioritization survey completed by 317 respondents from 43 countries. The top 10 research priorities for each of the four categories male infertility, female and unexplained infertility (including age-related infertility, ovarian cysts, uterine cavity abnormalities, and tubal factor infertility), medically assisted reproduction (including ovarian stimulation, IUI, and IVF), and ethics, access, and organization of care, were identified during a consensus development meeting involving 41 participants from 11 countries. These research priorities were diverse and seek answers to questions regarding prevention, treatment, and the longer-term impact of infertility. They highlight the importance of pursuing research which has often been overlooked, including addressing the emotional and psychological impact of infertility, improving access to fertility treatment, particularly in lower resource settings, and securing appropriate regulation. Addressing these priorities will require diverse research methodologies, including laboratory-based science, qualitative and quantitative research, and population science. LIMITATIONS, REASONS FOR CAUTION: We used consensus development methods, which have inherent limitations, including the representativeness of the participant sample, methodological decisions informed by professional judgement, and arbitrary consensus definitions. WIDER IMPLICATIONS OF THE FINDINGS: We anticipate that identified research priorities, developed to specifically highlight the most pressing clinical needs as perceived by healthcare professionals, people with fertility problems, and others, will help research funding organizations and researchers to develop their future research agenda. STUDY FUNDING/ COMPETING INTEREST(S): The study was funded by the Auckland Medical Research Foundation, Catalyst Fund, Royal Society of New Zealand, and Maurice and Phyllis Paykel Trust. Geoffrey Adamson reports research sponsorship from Abbott, personal fees from Abbott and LabCorp, a financial interest in Advanced Reproductive Care, committee membership of the FIGO Committee on Reproductive Medicine, International Committee for Monitoring Assisted Reproductive Technologies, International Federation of Fertility Societies, and World Endometriosis Research Foundation, and research sponsorship of the International Committee for Monitoring Assisted Reproductive Technologies from Abbott and Ferring. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and editor for the Cochrane Gynaecology and Fertility Group. Hans Evers reports being the Editor Emeritus of Human Reproduction. Andrew Horne reports research sponsorship from the Chief Scientist's Office, Ferring, Medical Research Council, National Institute for Health Research, and Wellbeing of Women and consultancy fees from Abbvie, Ferring, Nordic Pharma, and Roche Diagnostics. M. Louise Hull reports grants from Merck, grants from Myovant, grants from Bayer, outside the submitted work and ownership in Embrace Fertility, a private fertility company. Neil Johnson reports research sponsorship from Abb-Vie and Myovant Sciences and consultancy fees from Guerbet, Myovant Sciences, Roche Diagnostics, and Vifor Pharma. José Knijnenburg reports research sponsorship from Ferring and Theramex. Richard Legro reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. Ben Mol reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. Ernest Ng reports research sponsorship from Merck. Craig Niederberger reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and retains a financial interest in NexHand. Jane Stewart reports being employed by a National Health Service fertility clinic, consultancy fees from Merck for educational events, sponsorship to attend a fertility conference from Ferring, and being a clinical subeditor of Human Fertility. Annika Strandell reports consultancy fees from Guerbet. Jack Wilkinson reports being a statistical editor for the Cochrane Gynaecology and Fertility Group. Andy Vail reports that he is a Statistical Editor of the Cochrane Gynaecology & Fertility Review Group and of the journal Reproduction. His employing institution has received payment from HFEA for his advice on review of research evidence to inform their 'traffic light' system for infertility treatment 'add-ons'. Lan Vuong reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the present work. All authors have completed the disclosure form. TRIAL REGISTRATION NUMBER: Not applicable.

Cryostorage of reproductive tissues in the in vitro fertilization laboratory: a committee opinion.

This document is designed to assist in vitro fertility clinics in the management of cryopreserved reproductive tissues stored in cryogenic storage (cryostorage) tanks, based upon scientific principles and laboratory experience related to best practice for safe and reliable storage of cryopreserved reproductive tissue. Embryology and andrology laboratories provide storage of often irreplaceable reproductive tissues such as oocytes, embryos, sperm, and ovarian and testicular tissues, including tissues from cancer patients. All of these reproductive tissues must be maintained under stringent conditions.

Aneuploid embryo transfer: clinical policies and provider opinions at United States fertility clinics.

OBJECTIVE: To describe institutional clinical policies and individual provider opinions regarding aneuploid embryo transfer (aET). DESIGN: A survey about clinical policies was electronically sent to Society for Assisted Reproductive Technology (SART) member laboratory directors, and a separate survey about personal opinions was electronically sent to all SART members. SETTING: Not applicable. PATIENTS: Patients pursuing preimplantation genetic testing for aneuploidy (PGT-A). INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: Current clinical policies about aET were described. Individual provider opinions about aET in the context of specific aneuploidies and mosaicism were also described. RESULTS: A total of 48 laboratory directors and 212 individual providers responded to their respective surveys. Twelve (25%) clinics report that they do not have a policy regarding aET, but clinics performing PGT-A in >100 cycles per year were more likely to have a policy. Half of the individual providers agree that an embryo with trisomy 21 should be available for aET, but most disagreed with aET of embryos with other aneuploidies and most were either unsure about or unwilling to transfer embryos with mosaicism. Those who worked in primarily patient-facing roles held more agreeable opinions regarding aET. CONCLUSION: There is no consensus regarding ideal clinical policies for aET. The wide range of current clinical practices and individual provider opinions regarding under what circumstances, if any, aET should be available to patients indicates that this is a divisive issue among ART providers, and there is a clear need for specific professional guidelines to address this issue.

Which key performance indicators are most effective in evaluating and managing an in vitro fertilization laboratory?

The laboratory is the heart of an in vitro fertilization (IVF) clinic, and a quality management system is critical for its administration. We review the main structural, process, and outcome key performance indicators (KPIs) to provide laboratory managers with concrete tools aimed at enhancing the quality of their work. Three concepts must be stressed when dealing with KPIs in IVF: [1] always consider the three types of indicators (structural, process, and outcome related), [2] carefully adapt the control chart to either promptly identify issues and adopt corrective measures, or redefine the control limits in a process called "progress building," [3] consider that achieving a healthy live birth is a multidisciplinary effort that is subject to several confounders, which must be recognized and accounted for in the analyses. In this regard, future KPIs shared among clinicians and embryologists are desirable to enhance the quality of infertility care for IVF patients.

Introduction: Key performance indicators in assisted reproductive technologies.

Assisted reproductive technology (ART) has been so widely deployed across the world that over 1% of all births are now ART babies, with even higher percentages in the Nordic countries. As pregnancy rates are limited by technical, population, and inherent limitations of human reproduction, key performance indicators should be defined for all the different facets of ART to measure the efficacy of the procedure.

Reproductive Urologist and Gynecologist Involvement in Postvasectomy Sperm Retrieval Procedures at American Fertility Clinics.

OBJECTIVE: To evaluate reproductive urologist and reproductive endocrinologist practice patterns for postvasectomy surgical sperm retrieval at American private practice fertility clinics. METHODS: Private practice American fertility clinics were contacted by telephone and administered a telephone survey. In states with multiple large cities, several clinics in different cities were surveyed. Our primary endpoint was to determine what specialty of physician (urologist or reproductive endocrinology gynecologist) performed sperm retrieval procedures. Secondarily, we inquired about the location that these procedures were performed (urology vs gynecology clinic), type of anesthesia used, and cash cost for the procedure. RESULTS: Two hundred and twenty-five infertility clinics were contacted (per state range 2-10). 90.2% (203/225) of clinics responded to our queries. Zero clinics had an on-site urologist. An on-staff gynecologist with reproductive endocrinology training performed postvasectomy sperm retrievals in 9.4% (19/203) of clinics. A urologist "partnered" with the infertility clinic performed sperm retrievals at the fertility clinic in 11.8% (24/203) of clinics. 18.7% (38/203) did not offer sperm retrieval on-site, but did have a referral pattern established with a local urologist. Among reproductive endocrinologist performing sperm retrievals, intravenous anesthesia was used in 76.9% (10/13) of clinics. The quoted costs for surgical sperm retrieval performed by a reproductive endocrinologist ranged from $1000 to 10,000. CONCLUSION: Surgical sperm retrieval postvasectomy performed by an on-site reproductive endocrinologist was offered by 9.4% of contacted fertility clinics. The majority (76.9%) of these cases were routinely performed under intravenous anesthesia. Costs for reproductive endocrinologist performed sperm retrievals varied considerably. The reasons for, and safety of reproductive endocrinologists performing these procedures remains to be determined.

Preimplantation genetic testing for more than one genetic condition: clinical and ethical considerations and dilemmas.

STUDY QUESTION: Which clinical and ethical aspects of preimplantation genetic testing for monogenic disorders or structural rearrangements (PGT-M, PGT-SR) should be considered when accepting requests and counselling couples for PGT when applied for more than one condition (combination-PGT; cPGT-M/SR)? SUMMARY ANSWER: cPGT is a feasible extension of the practice of PGT-M/SR that may require adapting the criteria many countries have in place with regard to indications-setting for PGT-M/SR, while leading to complex choices that require timely counselling and information. WHAT IS KNOWN ALREADY: Although PGT-M/SR is usually performed to prevent transmission of one disorder, requests for PGT-M/SR for more than one condition (cPGT-M/SR) are becoming less exceptional. However, knowledge about implications for a responsible application of such treatments is lacking. STUDY DESIGN, SIZE, DURATION: Retrospective review of all (40) PGT-M/SR applications concerning more than one genetic condition over the period 1995-2018 in the files of the Dutch national PGT centre. This comprises all relevant national data since the start of PGT in the Netherlands. PARTICIPANTS/MATERIALS, SETTING AND METHODS: Data regarding cPGT-M/SR cases were collected by means of reviewing medical files of couples applying for cPGT-M/SR. Ethical challenges arising with cPGT-M/SR were explored against the background of PGT-M/SR regulations in several European countries, as well as of relevant ESHRE-guidance regarding both indications-setting and transfer-decisions. MAIN RESULTS AND THE ROLE OF CHANCE: We report 40 couples applying for cPGT-M/SR of which 16 couples started their IVF treatment. Together they underwent 39 IVF cycles leading to the birth of five healthy children. Of the couples applying for cPGT, 45% differentiated between a primary and secondary condition in terms of perceived severity. In the light of an altered balance of benefits and drawbacks, we argue the 'high risk of a serious condition' standard that many countries uphold as governing indications-setting, should be lowered for secondary conditions in couples who already have an indication for PGT-M/SR. As a consequence of cPGT, professionals will more often be confronted with requests for transferring embryos known to be affected with a condition that they were tested for. In line with ESHRE guidance, such transfers may well be acceptable, on the condition of avoiding a high risk of a child with a seriously diminished quality of life. LIMITATIONS, REASONS FOR CAUTION: We are the first to give an overview of cPGT-M/SR treatments. Retrospective analysis was performed using national data, possibly not reflecting current trends worldwide. WIDER IMPLICATIONS OF THE FINDINGS: Our observations have led to recommendations for cPGT-M/SR that may add to centre policy making and to the formulation of professional guidelines. Given that the introduction of generic methods for genomic analysis in PGT will regularly yield incidental findings leading to transfer requests with these same challenges, the importance of our discussion exceeds the present discussion of cPGT. STUDY FUNDING/COMPETING INTEREST(S): The research for this publication was funded by the Dutch Organization for Health Research and Development (ZonMw), project number: 141111002 (Long term safety, quality and ethics of Preimplantation Genetic Diagnosis). None of the authors has any competing interests to declare.