Video consultations in reproductive medicine: Safety, feasibility and patient satisfaction.

OBJECTIVE: To study the safety and feasibility of virtual consultations in reproductive medicine. DESIGN: This was a descriptive cross-sectional study involving subfertile patients attending a video consultation between September 2021 and August 2022. Clinicians conducting virtual consultations during the same period responded to a parallel survey for healthcare professionals. SETTING: University Hospital in Manchester, UK. PARTICIPANTS: Subfertile patients attending a virtual consultation. Healthcare professionals conducting virtual consultations. INTERVENTION: The survey link was offered in 4,932 consultations. A total of 577 (11.69%) patients responded and 510 completed the questionnaire (88.3%). MAIN OUTCOME MEASURES: Patient satisfaction measured as the percentage of patients preferring virtual to in person consultations. RESULTS: The majority of the patients (475, 91.70%) had a positive experience with the video consultation and just under half of the patients (152, 48.65%) preferred a video consultation to an in person consultation due to cost and time savings. Most patients (375, 72.68%) felt safer and less exposed to COVID-19. When the risk of COVID-19 subsides, 242 patients (47%) would still prefer to attend video consultations, while 169 (32.82%) had no preference. Analysis of the responses from patients reporting a negative experience identified technical problems as a possible cause. The virtual consultations appeared to be suitable for patients with disabilities. The clinicians' survey identified potential legal and ethical concerns. CONCLUSION: Virtual consultations are a safe and feasible alternative to in person consultations for subfertile patients. This large cross-sectional study revealed a high rate of patient satisfaction. Appropriate patient selection accounting for IT literacy, English language understanding and preference is crucial for successful virtual consultations. Further consideration should be given to ethical and legal challenges of virtual consultations. TRIAL REGISTRATION: Research Registry, UIN 6912, https://www.researchregistry.com/browse-the-registry.

The perspectives and psychological impact in subfertility couples as a consequence of postponement of fertility treatment due to Covid-19 pandemic: A cross-sectional study

Introduction: Coronavirus disease 2019 (Covid-19) brought forth an unprecedented suspension of fertility treatment worldwide as a result of reallocation of hospital staffs and resources. We aim to establish patient's perspective on how Covid-19 pandemic had affected their fertility treatment and to ascertain their psychological status. Methods: This is a cross-sectional study performed in a single academic center in Malaysia between July to December 2021. Patient and partner with any causes of infertility and who are planned for fertility treatment were approached and asked to answer an anonymous electronic survey. Results: 165 patients were recruited to answer the survey. 66% of patients did not agree with the Ministry of Health Malaysia's recommendation to postpone fertility treatment. 97.6%, if given a choice, would want to continue with treatment. 75.8% of patients' main concern about delaying treatment would be advancing age and 11.5% cite concerns about reducing ovarian reserve if their treatment was disrupted. Patient's psychological status assessment showed findings of mild, moderate, severe and extremely severe level of psychological disorders in our patients. From multivariate logistic regression, mild level of stress was significant amongst 20-30 years old with p=0.000 (OR 1.3E

Diabetes as a potential compounding factor in COVID-19-mediated male subfertility.

Recent work indicates that male fertility is compromised by SARS-CoV-2 infection. Direct effects derive from the presence of viral entry receptors (ACE2 and/or CD147) on the surface of testicular cells, such as spermatocytes, Sertoli cells, and Leydig cells. Indirect effects on testis and concentrations of male reproductive hormones derive from (1) virus-stimulated inflammation; (2) viral-induced diabetes, and (3) an interaction between diabetes and inflammation that exacerbates the deleterious effect of each perturbation. Reproductive hormones affected include testosterone, luteinizing hormone, and follicle-stimulating hormone. Reduction of male fertility is also observed with other viral infections, but the global pandemic of COVID-19 makes demographic and public health implications of reduced male fertility of major concern, especially if it occurs in the absence of serious symptoms that would otherwise encourage vaccination. Clinical documentation of COVID-19-associated male subfertility is now warranted to obtain quantitative relationships between infection severity and subfertility; mechanistic studies using animal models may reveal ways to mitigate the problem. In the meantime, the possibility of subfertility due to COVID-19 should enter considerations of vaccine hesitancy by reproductive-age males.

Knowledge of Fertility and Perception of Fertility Treatment Among Adults with Sickle Cell Disease (KNOW FERTILITY)

Background Adults with sickle cell disease (SCD) face unique fertility risks due to SCD and use of disease modifying therapies (DMTs). Concerns about compromising fertility may inform patients' therapy choices, but little is known about fertility knowledge in adults with SCD. The Cardiff Fertility Knowledge Scale (CFKS) and Fertility Treatment Perception Survey have been studied in international and national cohorts 1,2. The purpose of this study was to administer these surveys to adults with SCD and compare responses to previously studied populations. Methods Our IRB approved this cross-sectional study of adults with SCD (≥18YO) cared for at our Sickle Cell Center for Adults. Due to the COVID-19 pandemic, eligible subjects were recruited during routine telemedicine clinic visits and by invitation via electronic medical record. We collected demographic information (sex, age (≥/< 31YO), educational attainment, and use of DMTs). The CFKS is a 13-question survey that measures knowledge of causes of reduced fertility, common misconceptions about fertility, and infertility facts. Questions are answered True/False/Don't know and equally weighted;the cumulative score is 0-100%. We compared the mean CFKS scores to the scores from two published cohorts 1,2. The fertility treatment perception survey consists of two positive and four negative statements about fertility treatment with responses given on a five-point Likert scale (1= strongly disagree to 5= strongly agree). Responses are calculated by number of respondents with an agreement score of 4 and/or 5 divided by total number of respondents per sub-group;higher scores indicate stronger agreement. Analysis included summary statistics with means and standard deviations and independent student's T-test to compare the mean fertility knowledge scores. Results We contacted 435 subjects;91 respondents were enrolled (21% response rate). Respondents were 77% female [median age 33 years (IQR 23, 50)]. 51% completed high school or less and 18% used one or more DMTs, with 65% taking hydroxyurea. Table 1 shows the CFKS results. The average CFKS score was 50%, lower than the international cohort (50% vs. 57%, p<0.001) and higher than a cohort of Black women in Atlanta, GA (50% vs. 38%, p<0.001). Respondents with higher educational attainment had a higher score (55% secondary education vs. 44% primary education, p=0.04). The questions most answered correctly addressed the lack of correlation between erectile function and fertility (79%) and smoking's risk to fertility in men (69%) and women (71%). The questions least answered correctly were about classifying infertility (32%) and the impact of age effect (34%), overweight effect (25%), and sexually transmitted infections' effect on fertility (36%). There was no difference in knowledge scores by age, sex, or SCD treatment. Table 2 shows fertility treatment perception survey results. Some respondents (34%) agreed that fertility treatments are safe. Almost half (46%) agreed that fertility treatments are effective. Over 60% of respondents agreed that fertility treatments are scary and/or cause emotional problems, while 48% agreed that fertility treatments may have short-term physical effects. There was no difference in responses by sex, age, or SCD treatment. Conclusion In this study, we identify that higher educational attainment in adults with SCD is associated with better fertility knowledge. All subjects had low knowledge of sexually transmitted infections, weight gain, and older age as infertility risks. Although there is concern that hydroxyurea may compromise fertility, its use was not associated with greater fertility knowledge in this study. Given concerns about fertility in the SCD community, we identify an opportunity to support patients concerned about fertility by contextualizing real or theorized SCD-specific fertility risks within a broader set of established fertility risks. References: 1. Bunting L, Tsibulsky I, Boivin J. Fertility knowledge and beliefs about fertility treatment: findings from the International Fer ility Decision-making Study. Hum Reprod. 2013 Feb;28(2):385-97. doi: 10.1093/humrep/des402. Epub 2012 Nov 25. PMID: 23184181. 2. Wiltshire A, Brayboy LM, Phillips K, et al. Infertility knowledge and treatment beliefs among African American women in an urban community. Contracept Reprod Med. 2019 Sep 24;4:16. doi: 10.1186/s40834-019-0097-x. PMCID: PMC6757383. [Formula presented] Disclosures: Lanzkron: Shire: Research Funding;GBT: Research Funding;Novo Nordisk: Consultancy;CSL Behring: Research Funding;Pfizer: Current holder of individual stocks in a privately-held company;Teva: Current holder of individual stocks in a privately-held company;Novartis: Research Funding;Bluebird Bio: Consultancy;Imara: Research Funding.

Perspectives into the possible effects of the B.1.1.7 variant of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on spermatogenesis.

B.1.1.7 is a recently discovered variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) associated with increased transmissibility. Recent findings indicate that this variant has a propensity to infect adolescents and children at higher rates than adults. The virus gains entry into various body cells utilizing angiotensin-converting enzyme 2 (ACE-2) and basigin (CD147) as receptors. The virus mainly affects type II pneumocytes of lungs, endothelial cells, enterocytes, and renal tubular cells. It is reported to affect testes, causing testicular pain, and producing histopathological changes, as observed in some autopsies. The B.1.1.7 variant can also affect various cells in the testes. This raises a major concern regarding the long-term effects of the viral infection on spermatogenesis and highlights the pressing need for a robust database of serum samples from infected male children.

Exploring experiences of infertility amongst women and men in low-income and middle-income countries: protocol for a qualitative systematic review.

INTRODUCTION: Infertility is increasingly recognised as a global public health issue for women and men that merits further investigation to support policy and programming. While research in high-income settings has examined the consequences of infertility and access to services, there has been limited synthesis of how individuals experience infertility in low-income and middle-income countries (LMICs). This protocol describes a systematic review that will synthesise qualitative evidence on experiences of infertility among women and men in LMICs. METHODS AND ANALYSIS: The review will follow the Enhancing transparency in reporting the synthesis of qualitative research (ENTREQ) guidelines for reporting on qualitative evidence syntheses. The study team will search for published literature in PubMed, CINAHL and Scopus and PsycINFO databases and review available grey literature. Using Covidence software, two independent reviewers will conduct title and abstract screening based on inclusion and exclusion criteria, followed by full-text reviews and extraction by a larger team. Quality will be appraised using an adapted version of the Critical Appraisal Skills Programme guidelines. We will conduct thematic synthesis to characterise individual experiences and related factors at the individual, interpersonal, community and health system levels. We will develop a conceptual framework to describe evidence on experiences of infertility in LMICs and to help inform interventions across settings. ETHICS AND DISSEMINATION: This protocol has been internally approved as exempt by the Institutional Review Board of the Population Council, as it does not involve contact with human subjects or personally identifying data. Results of the review will be published in a peer-reviewed journal and will be used to inform future infertility research and programming in LMICs. PROSPERO REGISTRATION NUMBER: CRD42021227742.

Infertility Management Disruption During the COVID-19 Outbreak in a Middle-Income Country: Patients' Choices, Attitudes, and Concerns.

PURPOSE: This study aims to assess the degree of infertility management service disruption during the pandemic from the patient's point of view, as well as patients' attitudes toward seeking investigations and management, and their thoughts on how appropriate it is for health establishments to continue offering these services during this period while assessing their concerns regarding the risk of COVID-19 infection during treatment or pregnancy. METHODS: This study involved a cross-sectional survey of 213 women who were seeking infertility management in January 2021 in Jordan. An electronic questionnaire was designed and validated, which was then distributed on social media platforms. RESULTS: Over half of the participants had experienced some form of voluntary or involuntary disruption of their infertility management journey. The decision to postpone treatment was significantly associated with fear of infection (p = 0.009) and was more likely if they had undergone two or more previous cycles of in vitro fertilization treatment (p = 0.004). The majority of participants agreed that infertility services should remain available during the pandemic for those who chose not to delay their treatment journey, as the delay may have negative financial and psychological implications and may affect the chance to achieve a successful pregnancy in the future. CONCLUSION: The patients have faced uncertainty regarding the achievability of their long-term fertility goals amidst an atmosphere of general unpredictability for the duration and extent of disruption of their treatment, combined with the fear of infection. Therefore, it is necessary to highlight the need to address how infertility services can be maintained for those who decide to seek treatment during an outbreak while minimizing the risk of contracting COVID-19 in the process.

Comparing the cumulative live birth rate of cleavage-stage versus blastocyst-stage embryo transfers between IVF cycles: a study protocol for a multicentre randomised controlled superiority trial (the ToF trial).

INTRODUCTION: In vitro fertilisation (IVF) has evolved as an intervention of choice to help couples with infertility to conceive. In the last decade, a strategy change in the day of embryo transfer has been developed. Many IVF centres choose nowadays to transfer at later stages of embryo development, for example, transferring embryos at blastocyst stage instead of cleavage stage. However, it still is not known which embryo transfer policy in IVF is more efficient in terms of cumulative live birth rate (cLBR), following a fresh and the subsequent frozen-thawed transfers after one oocyte retrieval. Furthermore, studies reporting on obstetric and neonatal outcomes from both transfer policies are limited. METHODS AND ANALYSIS: We have set up a multicentre randomised superiority trial in the Netherlands, named the Three or Fivetrial. We plan to include 1200 women with an indication for IVF with at least four embryos available on day 2 after the oocyte retrieval. Women are randomly allocated to either (1) control group: embryo transfer on day 3 and cryopreservation of supernumerary good-quality embryos on day 3 or 4, or (2) intervention group: embryo transfer on day 5 and cryopreservation of supernumerary good-quality embryos on day 5 or 6. The primary outcome is the cLBR per oocyte retrieval. Secondary outcomes include LBR following fresh transfer, multiple pregnancy rate and time until pregnancy leading a live birth. We will also assess the obstetric and neonatal outcomes, costs and patients' treatment burden. ETHICS AND DISSEMINATION: The study protocol has been approved by the Central Committee on Research involving Human Subjects in the Netherlands in June 2018 (CCMO NL 64060.000.18). The results of this trial will be submitted for publication in international peer-reviewed and in open access journals. TRIAL REGISTRATION NUMBER: Netherlands Trial Register (NL 6857).

Evaluating the use of telemedicine in gynaecological practice: a systematic review.

OBJECTIVES: The aim of this systematic review is to examine the use of telemedicine in the delivery and teaching of gynaecological clinical practice. To our knowledge, no other systematic review has assessed this broad topic. DESIGN: Systematic review of all studies investigating the use of telemedicine in the provision of gynaecological care and education. The search for eligible studies followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and focused on three online databases: PubMed, Science Direct and SciFinder. ELIGIBILITY CRITERIA: Only studies within gynaecology were considered for this review. Studies covering only obstetrics and with minimal information on gynaecology, or clinical medicine in general were excluded. All English language, peer-reviewed human studies were included. Relevant studies published up to the date of final submission of this review were considered with no restrictions to the publication year. DATA EXTRACTIONS AND SYNTHESIS: Data extracted included author details, year of publication and country of the study, study aim, sample size, methodology, sample characteristics, outcome measures and a summary of findings. Data extraction and qualitative assessment were performed by the first author and crossed checked by the second author. Quality assessment for each study was assessed using the Newcastle-Ottawa scale. RESULTS: A literature search carried out in August 2020 yielded 313 records published between 1992 and 2018. Following a rigorous selection process, only 39 studies were included for this review published between 2000 and 2018. Of these, 19 assessed gynaecological clinical practice, eight assessed gynaecological education, one both, and 11 investigated the feasibility of telemedicine within gynaecological practice. 19 studies were classified as good, 12 fair and eight poor using the Newcastle-Ottawa scale. Telecolposcopy and abortion care were two areas where telemedicine was found to be effective in potentially speeding up diagnosis as well as providing patients with a wide range of management options. Studies focusing on education demonstrated that telementoring could improve teaching in a range of scenarios such as live surgery and international teleconferencing. CONCLUSIONS: The results of this review are promising and demonstrate that telemedicine has a role to play in improving clinical effectiveness and education within gynaecology. Its applications have been shown to be safe and effective in providing remote care and training. In the future, randomised controlled studies involving larger numbers of patients and operators with measurable outcomes are required in order to be able to draw reliable conclusions.