Empowering nurses and midwives: the evidence-base for the Nurses and Midwives Certification Programme of ESHRE†.

STUDY QUESTION: How were the logbook and curriculum for the Nurses and Midwives Certification Programme of ESHRE developed? SUMMARY ANSWER: The logbook and corresponding curriculum for the ESHRE Nurses and Midwives Certification Programme were based on an extensive literature review, an international expert panel, and a survey of Belgian and Dutch nurses and midwives (N&M) working in reproductive medicine (RM). WHAT IS KNOWN ALREADY: ESHRE has been running a certification programme for N&M working in RM since 2015. To the best of our knowledge, clinical practice guidelines for nursing/midwifery care within RM are lacking as is consensus on role descriptors of N&M working in RM. STUDY DESIGN, SIZE, DURATION: The Nurses and Midwives Certification Committee (NMCC), established by the ESHRE Executive Committee in 2012, decided to gather background information by: (i) systematically reviewing the literature on the tasks of N&M working in RM, (ii) consulting and surveying an expert panel of international senior N&M, and (iii) surveying Belgian and Dutch N&M working in RM across different clinics. Finally, the NMCC developed a logbook and curriculum fostering a more expanded theoretic background. PARTICIPANTS/MATERIALS, SETTING, METHODS: The NMCC comprised four N&M, one clinical embryologist, and one gynaecologist (both in an advisory capacity). The Medline database was searched for papers relating to the tasks of N&M working in RM, by entering a search string in PubMed. In an attempt to capture insight into the tasks and roles of N&M working in RM, the NMCC subsequently surveyed N&M experts across nine countries (Denmark, Finland, France, Norway, Slovenia, Sweden, Turkey, Ukraine, and the UK), and 48 Belgian and Dutch N&M working in RM. MAIN RESULTS AND THE ROLE OF CHANCE: There were 36 papers on the tasks of N&M working in RM originating from 13 countries (in Asia, Oceania, Europe, and North America), identified. Initially, 43 tasks in which N&M working in RM participated, were identified by literature only (n = 5), the international expert panel only (n = 4), Belgian and Dutch N&M working in RM only (n = 5), or a combination of two (n = 13) or three (n = 16) of these sources. The number and composition of tasks included in the logbook were adapted yearly based on novel insights by the NMCC. In response to the annual review, the extended role of N&M working in RM is now reflected in the 2024 version by 73 tasks. Seven specialist tasks (i.e. embryo transfer) were performed independently by N&M working in RM in some countries, while in other countries N&M merely had an 'assisting' role. Candidates are also expected to submit a mature ethical reflection on one clinical case. To support applicants throughout the certification process, the NMCC developed a curriculum in line with all tasks of N&M working in RM. LIMITATIONS, REASONS FOR CAUTION: The literature review was not completed prior to consulting the international expert panel or surveying the Belgian and Dutch N&M working in RM. WIDER IMPLICATIONS OF THE FINDINGS: The differences in tasks and roles of N&M working in RM across and within countries, clinics and individuals illustrated by the literature review, the international expert panel, and the surveyed Belgian and Dutch N&M working in RM suggest an opportunity for structured professional development. Further research is required to elicit the post-certification experience of N&M working in RM and its impact on their professional development. STUDY FUNDING/COMPETING INTEREST(S): The expert panel meeting was funded by ESHRE and the literature review and surveys were supported by Leuven University (Belgium) and the postdoctoral fellowship of the Research Foundation Flanders of E.A.F.D. H.K. received consulting fees and honoraria from Gedeon Richter, Finox and MEDEA, and travel support from Gedeon Richter and Finox. The other authors declare no conflict of interest. TRIAL REGISTRATION NUMBER: N/A.

Current recommendations for vaccines for patients planning pregnancy: a committee opinion.

Encounters for infertility care are opportunities to assess and update immunization status. Individuals of reproductive age are often unaware of their need for immunization, their immunization status, and the potentially severe consequences of preventable disease on pregnancy outcome. The purpose of this American Society for Reproductive Medicine (ASRM) Practice Committee document is to summarize current recommendations regarding vaccinations for individuals of reproductive age. This document replaces the ASRM Practice Committee document titled "Vaccination guidelines for female infertility patients," last published in 2018 (Fertil Steril 2018;110:838-41).

Mixed models for repetitive measurements: the basics.

Linear mixed models are regularly used within the field of reproductive medicine. This manuscript explains the basics of mixed models, when they could be used, and how they could be applied.

Best methods in reproductive medicine clinical trials.

This introduction is to a Views and Reviews series of articles outlining best practices in the design and analysis of reproductive medicine articles. The investigators are experienced researchers and biostatisticians who highlight key points with illustrative examples from both published and theoretical clinical studies. This series is meant not only to educate readers in the interpretation of clinical research studies but also to inspire better-designed studies in the future.

Current evaluation of amenorrhea: a committee opinion.

The purpose of this American Society for Reproductive Medicine Practice Committee Opinion is to provide clinicians with principles and strategies for the diagnostic evaluation of patients presenting with primary or secondary amenorrhea. This revised document replaces the Practice Committee Document titled "Current evaluation of amenorrhea," last published in 2008 (Fertil Steril 2008;90:S219-25).

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.

Multiple gestation associated with infertility therapy: a committee opinion.

This Committee Opinion provides practitioners with suggestions to reduce the likelihood of iatrogenic multiple gestation resulting from infertility treatment. This document replaces the document of the same name previously published in 2012 (Fertil Steril 2012;97:825-34 by the American Society for Reproductive Medicine).

Optimizing natural fertility: a committee opinion.

This committee opinion provides practitioners with suggestions for optimizing the likelihood of achieving pregnancy in couples or individuals attempting conception who have no evidence of infertility. This document replaces the document of the same name previously published in 2013 (Fertil Steril 2013;100:631-7).

Teaming for excellence: challenges and collaboration in the world of reproductive clinical and translational research.

To succeed in the conduct of clinical trials in reproductive medicine, teams must be trained and cultivated to collaborate and achieve a common goal. Here I share my personal experiences and lessons learned in teaming in the research setting by covering topics in time management, resource allocation, collaboration, publishing, and communication.

Guidance on the limits to the number of embryos to transfer: a committee opinion.

On the basis of American Society for Reproductive Medicine and Society for Assisted Reproductive Technology data, the American Society for Reproductive Medicine's guidelines for the limits on the number of embryos to be transferred during in vitro fertilization cycles have been further refined in continuing efforts to promote singleton gestation and reduce the number of multiple pregnancies. This version replaces the document titled "Criteria for number of embryos to transfer: a committee opinion" that was published most recently in August of 2017 (Fertil Steril 2017;107:901-3).

Evidence-based outcomes after oocyte cryopreservation for donor oocyte in vitro fertilization and planned oocyte cryopreservation: a guideline.

OBJECTIVE: To provide evidence-based recommendations to practicing physicians and others regarding the efficacy of oocyte cryopreservation (OC) for donor oocyte in vitro fertilization and planned OC. METHODS: The American Society for Reproductive Medicine conducted a literature search, which included systematic reviews, meta-analyses, randomized controlled trials, and prospective and retrospective comparative observational studies published from 1986 to 2018. The American Society for Reproductive Medicine Practice Committee and a task force of experts used available evidence and through consensus developed evidence-based guideline recommendations. MAIN OUTCOME MEASURE(S): Outcomes of interest included live birth rate, clinical pregnancy rate, obstetrical and neonatal outcomes, and factors predicting reproductive outcomes. RESULT(S): The literature search identified 30 relevant studies to inform the evidence base for this guideline. RECOMMENDATION(S): Evidence-based recommendations were developed for predicting the likelihood of live births after planned OC, autologous OC in infertile women, and donor OC, as well as factors that may impact live birth rates. Recommendations were developed regarding neonatal outcomes after using fresh vs. cryopreserved oocytes in cases of autologous or donor oocytes. CONCLUSION(S): There is insufficient evidence to predict live birth rates after planned OC. On the basis of limited data, ongoing and live birth rates appear to be improved for women who undergo planned OC at a younger vs. older age. Although there are no significant differences in per transfer pregnancy rates with cryopreserved vs. fresh donor oocytes, there is insufficient evidence that the live birth rate is the same with vitrified vs. fresh donor oocytes. Neonatal outcomes appear similar with cryopreserved oocytes compared with fresh oocytes. Future studies that compare cumulative live birth rates are needed.

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.

Scanning Probe Microscopies: Imaging and Biomechanics in Reproductive Medicine Research.

Basic and translational research in reproductive medicine can provide new insights with the application of scanning probe microscopies, such as atomic force microscopy (AFM) and scanning near-field optical microscopy (SNOM). These microscopies, which provide images with spatial resolution well beyond the optical resolution limit, enable users to achieve detailed descriptions of cell topography, inner cellular structure organization, and arrangements of single or cluster membrane proteins. A peculiar characteristic of AFM operating in force spectroscopy mode is its inherent ability to measure the interaction forces between single proteins or cells, and to quantify the mechanical properties (i.e., elasticity, viscoelasticity, and viscosity) of cells and tissues. The knowledge of the cell ultrastructure, the macromolecule organization, the protein dynamics, the investigation of biological interaction forces, and the quantification of biomechanical features can be essential clues for identifying the molecular mechanisms that govern responses in living cells. This review highlights the main findings achieved by the use of AFM and SNOM in assisted reproductive research, such as the description of gamete morphology; the quantification of mechanical properties of gametes; the role of forces in embryo development; the significance of investigating single-molecule interaction forces; the characterization of disorders of the reproductive system; and the visualization of molecular organization. New perspectives of analysis opened up by applying these techniques and the translational impacts on reproductive medicine are discussed.

Diagnosis and treatment of luteal phase deficiency: a committee opinion.

Luteal phase deficiency (LPD) is a clinical diagnosis associated with an abnormal luteal phase length of ≤10 days. Potential etiologies of LPD include inadequate progesterone duration, inadequate progesterone levels, or endometrial progesterone resistance. LPD has not only been described in association with medical conditions but also in fertile, normally menstruating women. Although progesterone is important for the process of implantation and early embryonic development, LPD has not been proven to be an independent entity causing infertility or recurrent pregnancy loss. Controversy exists regarding the multiple proposed measures for diagnosing LPD and, assuming it can be diagnosed accurately, whether treatment improves outcomes. This document replaces the document entitled "Current clinical irrelevance of luteal phase deficiency: a committee opinion," last published in 2015 (Fertil Steril 2015;103:e27-e32).

Guidance for using text, email, and video communication in practices devoted to reproductive medicine.

The prevalence and ease of electronic communication, specifically email through patient portals associated with electronic medical records or via traditional enterprise email clients (e.g., Outlook) and video, have resulted in increased use for rapid communication between practitioners and their patients. Concerns regarding patient privacy and compliance with the regulations of the Health Insurance Portability and Accountability Act (HIPAA) remain a barrier to routine incorporation of electronic communication into practice. Furthermore, capital investment, implementation, and maintenance costs may provide additional barriers. These long-standing concerns have been heightened and tested by the COVID-19 pandemic. Best-practice guidelines for the secure and safe use of electronic communication with reproductive care patients are provided.

Guidance regarding gamete and embryo donation.

This document provides the latest recommendations for the evaluation of potential sperm, oocyte, and embryo donors as well as their recipients, incorporating recent information about optimal screening and testing for sexually transmitted infections, genetic diseases, and psychological assessments. This revised document incorporates recent information from the US Centers for Disease Control and Prevention, US Food and Drug Administration, and American Association of Tissue Banks, which all programs offering gamete and embryo donation services must be thoroughly familiar with, and replaces the document titled "Recommendations for gamete and embryo donation: a committee opinion," last published in 2013.

Guidance on qualifications for fertility counselors: a committee opinion.

This guidance document was developed by the Mental Health Professional Group (MHPG) in partnership with the Practice Committee of the American Society for Reproductive Medicine (ASRM) to help determine the qualifications and training of mental health professionals working in reproductive medicine. This document replaces the document titled "ASRM Qualification Guidelines for Infertility," last published in March 2015 and originally developed in 1995.