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OBJECTIVE: The objective of this study was to examine the hypothesis that experiences with patient-centered endometriosis care are related to the endometriosis-specific quality of life dimensions "emotional well-being" and "social support." DESIGN: A secondary regression analysis of two cross-sectional studies was conducted. Participants/Materials: In total, data from 300 women were eligible for analysis. The participating women all had surgically proven endometriosis. SETTING: The study was conducted in one secondary and two tertiary endometriosis clinics in the Netherlands. Questionnaires were disseminated between 2011 and 2016. METHODS: Both included studies investigated patient-centeredness of endometriosis care and endometriosis-specific quality of life using, respectively, the ENDOCARE questionnaire (ECQ) and the Endometriosis Health Profile 30 (EHP-30). To increase power, the regression analysis focused on the previously found relation between the ten dimensions of the ECQ and the EHP-30 domains "emotional well-being" and "social support" rather than all five EHP-30 domains. After the Bonferroni correction to limit type 1 errors, the adjusted p value was 0.003 (0.05/20). RESULTS: The participating women had a mean age of 35.7 years and had predominantly been diagnosed with moderate to severe endometriosis. None of the relations between patient-centered endometriosis care and the EHP-30 domain "emotional well-being" were significant. Three dimensions of patient-centered endometriosis care proved to be significantly related to the EHP-30 domain "social support": "information, communication, and education" (p < 0.001, beta = 0.436), "coordination and integration of care" (p = 0.001, beta = 0.307), and "emotional support and alleviation of fear and anxiety" (p = 0.002, beta = 0.259). LIMITATIONS: This cross-sectional study identified relations rather than proving causality between experiencing less patient-centeredness of care and having lower quality of life. Nevertheless, it is very tangible that some causality exists, either directly or indirectly (e.g., through empowerment) and that by improving patient-centeredness, quality of life might be improved as well. CONCLUSION: "Information, communication, and education"; "coordination and integration of care"; and "emotional support and alleviation of fear and anxiety" as dimensions of patient-centered endometriosis care are related to the quality of life domain "social support" of women with endometriosis. Improving the patient-centeredness of endometriosis care was already considered an important goal, but even more so given its relation with women's quality of life, which is increasingly considered the ultimate measure of health care quality. Quality improvement projects focusing on "information, communication, and education" are expected to impact women's quality of life the most.
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Endometriose , Qualidade de Vida , Feminino , Humanos , Adulto , Endometriose/complicações , Estudos Transversais , Ansiedade/etiologia , Inquéritos e Questionários , Assistência Centrada no PacienteRESUMO
This review appraises evidence on the difference between single- and double-embryo transfer (SET, DET) in assisted reproductive technology (ART) regarding the four healthcare quality dimensions most important to fertility patients and doctors. Regarding safety, not only does DET create the uncontested perinatal risks of twin pregnancies, but compelling evidence has added that singleton pregnancies after a vanishing twin also have poorer perinatal outcomes. SET is as effective as DET, as shown by meta-analyses of randomized controlled trials, comparing two cycles of SET versus DET and shown by cumulative live birth rates of entire ART trajectories of up to six cycles. Proposing SET, which is safer than DET and as effective, as the gold standard is not irreconcilable with patient-centred care if patients are thoroughly informed on the reasoning behind the proposition and welcomed to challenge whether it fits their personal values. The cost-efficiency of SET is clearly higher, which has even induced certain countries to start reimbursing ART on the condition that SET is used. In conclusion, SET should be the gold standard offered to all patients. The question is not whether to apply SET but how to apply it in terms of patient selection, patient-centred counselling and coverage of treatment.
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Transferência Embrionária , Medicina Reprodutiva , Feminino , Humanos , Gravidez , Transferência Embrionária/métodos , Fertilização in vitro , Taxa de Gravidez , Qualidade da Assistência à SaúdeRESUMO
RESEARCH QUESTION: How much do patients with severe infertility and their gynaecologists value genetic parenthood relative to other key treatment characteristics? DESIGN: A discrete choice experiment included the following treatment characteristics: genetic parenthood, pregnancy rate, curing infertility, maternal health, child health and costs. The questionnaire was disseminated between 2015 and 2016 among Dutch and Belgian patients with severe infertility and their gynaecologists. RESULTS: The questionnaire was completed by 173 patients and 111 gynaecologists. When choosing between treatments that varied in safety, effectiveness and costs, the treatment's ability to lead to genetic parenthood did not affect the treatment preference of patients with severe infertility (nâ¯=â¯173). Genetic parenthood affected the treatment preference of gynaecologists (nâ¯=â¯111) less than all other treatment characteristics. Patients indicated that they would switch to a treatment that did not enable genetic parenthood in return for a child health risk reduction of 3.6%, a cost reduction of 3500, an ovarian hyperstimulation risk reduction of 4.6%, a maternal cancer risk reduction of 2.7% or a pregnancy rate increase of 18%. Gynaecologists made similar trade-offs. CONCLUSIONS: While awaiting replication of this study in larger populations, these findings challenge the presumed dominant importance of genetic parenthood. This raises questions about whether donor gametes could be presented as a worthy alternative earlier in treatment trajectories and whether investments in novel treatments enabling genetic parenthood, like in-vitro gametogenesis, are proportional to their future clinical effect.
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Patrimônio Genético , Células Germinativas , Padrões de Herança/genética , Relações Pais-Filho , Pais/psicologia , Percepção , Doadores de Tecidos/psicologia , Adulto , Atitude Frente a Saúde , Comportamento de Escolha/fisiologia , Feminino , Doenças Genéticas Inatas/genética , Doenças Genéticas Inatas/psicologia , Humanos , Recém-Nascido , Infertilidade/patologia , Infertilidade/psicologia , Infertilidade/terapia , Masculino , Pessoa de Meia-Idade , Gravidez , Técnicas de Reprodução Assistida/psicologia , Fatores de Risco , Inquéritos e QuestionáriosRESUMO
In this cross-sectional study, we investigated whether patient-centred endometriosis care (PCEC) is associated with health-related quality of life (HRQOL). Dutch-speaking women with endometriosis, treated by laparoscopy in a university clinic between 2009 and 2010, were eligible (n = 194). Endometriosis Health Profile-30 and ENDOCARE questionnaire were used to assess HRQOL and PCEC, respectively. Overall and subscale scores were converted to a scale from 0 (best score) to 100 (worst score). Linear regression analyses were conducted while controlling for confounders. Participants (n = 109) had a mean age of 35.4 years; 79.6% had moderate-severe endometriosis. Mean scores for overall HRQOL and PCEC were 29.3/100 and 38.0/100, respectively. The PCEC-subscale 'continuity' was significantly associated with overall HRQOL (P = 0.029). A significant association was found between overall PCEC and the HRQOL-subscale 'social support' (P = 0.026). The PCEC-subscales 'information' and 'continuity' were significantly associated with the HRQOL-subscales 'emotional wellbeing' and 'social support' (P < 0.05). The PCEC-subscale 'respect' was significantly associated with the HRQOL-subscale 'emotional wellbeing' (P = 0.023). Multivariable regression analyses produced no significant associations, including all subscales of PCEC. Providing PCEC could lead to better HRQOL, especially if paying attention to 'continuity', 'respect' and 'information'. Large-scale longitudinal research is needed.
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Endometriose/terapia , Assistência Centrada no Paciente , Adulto , Estudos Transversais , Endometriose/psicologia , Feminino , Humanos , Qualidade de VidaRESUMO
BACKGROUND: Endometriosis in adolescent girls is often diagnosed after a long delay. This diagnostic delay can be associated with more advanced stages of endometriosis and with a higher likelihood of fertility problems at a later age. MATERIAL AND METHODS: A systematic review of literature and quality assessment was performed in order to identify questionnaires that were developed to identify adult women with endometriosis. Based on these questionnaires, specific questions that had been reported to be predictive for endometriosis were selected and included in a newly composed questionnaire with the aim to identify adolescents at risk of developing endometriosis. RESULTS: Based on the literature, we identified 5 questionnaires developed to identify adult women with endometriosis; this questionnaire contained 6 questions that had been reported to be predictive for adult endometriosis. These questions query age of menarche, cycle duration, dysmenorrhea, pain descriptors, dyschezia and urinary symptoms and were combined into a new self-report questionnaire aimed to identify adolescents at risk to develop endometriosis. CONCLUSION: We developed a self-report questionnaire aimed to identify adolescents at risk to develop endometriosis based on questions from self-report questionnaires that have been reported to identify adult women with endometriosis.
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Endometriose/diagnóstico , Programas de Rastreamento/métodos , Medição de Risco/métodos , Inquéritos e Questionários , Adolescente , Adulto , Fatores Etários , Constipação Intestinal , Diagnóstico Tardio/prevenção & controle , Dismenorreia/complicações , Endometriose/etiologia , Feminino , Humanos , Menarca , Adulto JovemRESUMO
BACKGROUND: Endometriosis is a prevalent condition compromising physical and psychosocial health and thus requiring patient-centered care, which is guided by patients' values. This study aimed to find out what the patient's perspective on endometriosis care is and how the patient-centeredness of endometriosis care can be improved. METHODS: Electronic databases were searched systematically, and study selection was based on eligibility and quality. Study methodology was examined. Specific care aspects valued by patients were organized according to 10 dimensions of patient-centered endometriosis care. Based on patients' assessments of service quality, patient-centered improvement targets and strengths were identified. RESULTS: Twelve of 20 eligible studies had sufficient quality to be included. Endometriosis patients valued all 10 dimensions of patient-centered endometriosis care. Problematic service quality was reported for all dimensions but 'coordination and integration' and 'involvement of significant others'. Two patient-centered strengths and 29 patient-centered improvement targets were identified. The most frequently reported improvement targets on which studies agreed were 'timely diagnosis' and 'being believed and respected by staff'. CONCLUSION: Endometriosis patients value patient-centeredness in addition to effectiveness and safety of care, and its 10 dimensions require attention in clinical practice. Research into the assessment and improvement of patient-centered endometriosis care is required.
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Endometriose/terapia , Assistência Centrada no Paciente , Emoções , Empatia , Endometriose/diagnóstico , Endometriose/psicologia , Feminino , Humanos , MEDLINE , Satisfação do Paciente , Relações Médico-Paciente , Qualidade da Assistência à Saúde , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Gonadotrophin-releasing hormone (GnRH) antagonists reduce ovarian hyperstimulation syndrome (OHSS) at the price of a small reduction in effectiveness compared to GnRH agonists. The aim of this study was to investigate patients' preferences on effectiveness, safety and burden of GnRH analogs. METHODS: A discrete choice experiment (DCE) and a trade-off question were designed. Patients embarking on assisted reproductive technique treatment were asked to choose between two hypothetical medications which differed in effectiveness, safety and burden. RESULTS: A total of 172 questionnaires were analyzed. All attributes of the DCE had a statistically significant impact on the preference of the respondents. Respondents were willing to trade off 0.87 and 0.81% effectiveness for a decrease in OHSS risk and for fewer side effects, respectively. Respondents were not willing to trade off effectiveness for 'importance of compliance' (trade-off 0.40%) or a shorter 'duration of treatment' (trade-off 0.26%). The trade-off questions showed that already at a 2.0% increase in pregnancy rate in favor of the agonists, the majority of the respondents changed their preference from antagonists to agonists (2.0%, 95% CI 1.7-2.1). CONCLUSION: Safety and burden are important to patients, but are not important enough to make up for a small decrease in pregnancy rate.
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Fertilização in vitro/efeitos adversos , Fertilização in vitro/métodos , Hormônio Liberador de Gonadotropina/análogos & derivados , Hormônio Liberador de Gonadotropina/antagonistas & inibidores , Preferência do Paciente , Feminino , Fertilização in vitro/psicologia , Humanos , Países Baixos , Síndrome de Hiperestimulação Ovariana/induzido quimicamente , Síndrome de Hiperestimulação Ovariana/prevenção & controle , Gravidez , Taxa de Gravidez , Inquéritos e Questionários , Resultado do TratamentoRESUMO
STUDY QUESTION: What information and support should be offered to donors, intended parents and donor-conceived people, in general and in consideration of the availability of direct-to-consumer genetic testing and matching services? SUMMARY ANSWER: For donors, intended parents and donor-conceived offspring, recommendations are made that cover information needs and informed consent, psychosocial implications and disclosure. WHAT IS KNOWN ALREADY: Trends indicate that the use of donor-assisted conception is growing and guidance is needed to help these recipients/intended parents, the donors and offspring, navigate the rapidly changing environment in which donor-assisted conception takes place. STUDY DESIGN SIZE DURATION: A working group (WG) collaborated on writing recommendations based, where available, on evidence collected from a literature search and expert opinion. Draft recommendations were published for stakeholder review and adapted where relevant based on the comments received. PARTICIPANTS/MATERIALS SETTING METHODS: Papers retrieved from PUBMED were included from 1 January 2014 up to 31 August 2020, focusing on studies published since direct-to-consumer genetic testing has become more widespread and accessible. The current paper is limited to reproductive donation performed in medically assisted reproduction (MAR) centres (and gamete banks): donation outside the medical context was not considered. MAIN RESULTS AND THE ROLE OF CHANCE: In total, 32 recommendations were made for information provision and support to donors, 32 for intended parents and 27 for donor-conceived offspring requesting information/support. LIMITATIONS REASONS FOR CAUTION: The available evidence in the area of reproductive donation is limited and diverse with regards to the context and types of donation. General conclusions and recommendations are largely based on expert opinion and may need to be adapted in light of future research. WIDER IMPLICATIONS OF THE FINDINGS: These recommendations provide guidance to MAR centres and gamete banks on good practice in information provision and support but should also be considered by regulatory bodies and policymakers at a national and international level to guide regulatory and legislative efforts towards the protection of donors and donor-conceived offspring. STUDY FUNDING/COMPETING INTERESTS: The development of this good practice paper was funded by European Society of Human Reproduction and Embryology (ESHRE), covering expenses associated with the WG meetings, the literature searches and dissemination. The WG members did not receive any payment. The authors have no conflicts of interest to declare. DISCLAIMER: This document represents the views of ESHRE, which are the result of consensus between the relevant ESHRE stakeholders and where relevant based on the scientific evidence available at the time of preparation. The recommendations should be used for informational and educational purposes. They should not be interpreted as setting a standard of care, or be deemed inclusive of all proper methods of care nor exclusive of other methods of care reasonably directed to obtaining the same results. They do not replace the need for application of clinical judgement to each individual presentation, nor variations based on locality and facility type. ESHRE pages content is not externally peer reviewed. The manuscript has been approved by the Executive Committee of ESHRE.
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STUDY QUESTION: What are the experiences and the support and sexual advice needs of subfertile couples continuing to attempt natural conception after the diagnostic fertility work-up? SUMMARY ANSWER: Exploration of the experiences of couples showed that couples would have appreciated fertility clinic staff embedding expectant management into the fertility clinic trajectory, supportive staff with female and male patient interactions and advice on common experiences of peers and on managing their lifestyle, distress and subfertility-related sexual challenges. WHAT IS KNOWN ALREADY: Dutch and British professional guidelines advise newly diagnosed subfertile couples with a 'good prognosis' to continue to attempt natural conception and do not require fertility clinic staff to interact with patients. Fertility clinic staff and subfertile couples struggle to follow these guidelines as they feel an urgent need for action. Subfertile couples might benefit from sexual advice, as subfertility is negatively associated with sexual functioning, which is important for natural conception. STUDY DESIGN SIZE DURATION: Twelve one-time in-depth interviews (2015-2017) were conducted with 10 heterosexual couples and 2 women whose partners did not participate, then the interviews were subjected to inductive content analysis, reaching inductive thematic saturation. PARTICIPANTS/MATERIALS SETTING METHODS: The 22 interviewees had experienced 3-18 months of expectant management after their diagnostic fertility work-up in a Belgian or a Dutch tertiary fertility clinic. The face-to-face in-depth interviews explored positive and negative experiences and unmet needs. The transcribed interviews were subjected to inductive content analysis, by two researchers discussing initial disagreements. MAIN RESULTS AND THE ROLE OF CHANCE: Couples would appreciate fertility clinic staff embedding expectant management in the fertility clinic trajectory, by starting off with reassuring couples that their very thorough diagnostic fertility work-up demonstrated their good chance of natural conception, and by involving couples in deciding on the duration of expectant management and by planning the follow-up appointment after expectant management up front. Couples had encountered sexual challenges during expectant management and had an interest in sexual advice, focused on increasing pleasure and partner bonding and preventing the rise of dysfunctions. The couples agreed that a (secured) website with evidence-based, non-patronizing text and mixed media would be an appropriate format for a novel support programme. Couples were keen for interactions with fertility clinic staff which addressed both partners of subfertile couples. Couples also valued advice on managing their lifestyle and distress and would have liked information on the experiences of their peers. LIMITATIONS REASONS FOR CAUTION: Recall bias is plausible given the retrospective nature of this study. This explorative interview study was not designed for examining country or gender differences in experiences and needs but it did generate new findings on inter-country differences. WIDER IMPLICATIONS OF THE FINDINGS: Rather than simply advising expectant management, fertility clinics are encouraged to offer couples who continue to attempt natural conception after their diagnostic fertility work-up, supportive patient-staff interactions with advice on common experiences of peers and on managing their lifestyle, distress and sexual challenges related to subfertility. STUDY FUNDING/COMPETING INTERESTS: Funded by Flanders Research Foundation and the University of Amsterdam. There are no competing interests. TRIAL REGISTRATION NUMBER: N/A.
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Cycle monitoring via ultrasound and serum-based hormonal assays during medically assisted reproduction (MAR) can provide information on ovarian response and assist in optimizing treatment strategies in addition to reducing complications such as ovarian hyperstimulation syndrome (OHSS). Two surveys conducted in 2019 and 2020, including overall 24 fertility specialists from Europe, Asia and Latin America, confirmed that the majority of fertility practitioners routinely conduct hormone monitoring during MAR. However, blood tests may cause inconvenience to patients. The reported drawbacks of blood tests identified by the survey included the validity of results from different service providers, long waiting times and discomfort to patients due to travelling to clinics for tests and repeated venepunctures. Historically, urine-based assays were used by fertility specialists in clinics but were subsequently replaced by more practical and automated serum-based assays. A remote urine-based hormonal assay could be an alternative to current serum-based testing at clinics, reducing the inconvenience of blood tests and the frequency of appointments, waiting times and patient burden. Here we provide an overview of the current standard of care for cycle monitoring and review the literature to assess the correlation between urine-based hormonal assays and serum-based hormonal assays during MAR. In addition, in this review, we discuss the evidence supporting the introduction of remote urine-based hormonal monitoring as part of a novel digital health solution that includes remote ultrasound and tele-counselling to link clinics and patients at home.
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Síndrome de Hiperestimulação Ovariana , Telemedicina , Feminino , Humanos , Fertilização in vitro/métodos , Reprodução , HormôniosRESUMO
BACKGROUND: High-quality healthcare should be effective, safe and patient-centred. How important patient-centredness is in relation to effectiveness of fertility care has never been investigated. This study aimed to determine and compare the importance of patient-centredness, relative to pregnancy rates, to patients and physicians. METHODS: A discrete choice experiment (DCE) was designed. Participants had to choose between hypothetical fertility clinics differing in following attributes: travel time; pregnancy rate (effectiveness); physicians' attitude; information on treatment; and continuity of physicians (the latter three represent patient-centredness). A total of 1378 patients and 268 physicians from eight Dutch and Belgian fertility clinics received the DCE-questionnaire. The attributes' relative importance was analysed using multinomial logistic regression. Additionally, patients' actual choice behaviour was investigated. RESULTS: In total, 925 patients and 227 physicians participated. Pregnancy rates were relatively more important to physicians. Patients assigned more value to patient-centredness (P < 0.001) and were willing to trade-off a higher pregnancy rate for patient-centredness than physicians recommended them to do (P < 0.05). For example, patients considered pregnancy rates 1.5 times as important as an interested physician's attitude, whereas physicians considered this 2.4 times as important (P < 0.001). The willingness to trade-off pregnancy rate for this attitude was 9.8% for patients and 6.3% for physicians (P < 0.001). A lack of patient-centredness was the most cited non-medical reason for changing fertility clinics. CONCLUSIONS: Patients and physicians put considerable value on pregnancy rates. However, physicians significantly undervalue the importance of patient-centredness to patients. Clinics aiming to optimize the quality of their services should be aware of the substantial importance their patients assign to patient-centredness.
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Atitude do Pessoal de Saúde , Atitude Frente a Saúde , Comportamento de Escolha , Infertilidade/terapia , Assistência Centrada no Paciente , Médicos/psicologia , Técnicas de Reprodução Assistida , Adulto , Idoso , Bélgica , Feminino , Grupos Focais , Humanos , Infertilidade/psicologia , Masculino , Pessoa de Meia-Idade , Países Baixos , Gravidez , Taxa de Gravidez , Serviços de Saúde Reprodutiva , Técnicas de Reprodução Assistida/psicologia , Inquéritos e Questionários , Fatores de Tempo , Adulto JovemRESUMO
INTRODUCTION: Many subfertile couples are diagnosed with (relatively) unexplained subfertility and a good prognosis. National professional guidelines (eg, the Netherlands and UK) advise 'expectant management (EM)' for 6-12 months, in which no interaction with healthcare staff is offered. Underpowered studies indicate that face-to-face sex-counselling increases the ongoing pregnancy rates of these couples. In patients with other conditions, web-based interactive educational programmes have the same effect on sexual functioning as face-to-face sex counselling. The 'Pleasure&Pregnancy randomised controlled trial (RCT)' will examine in couples with unexplained subfertility and a good prognosis whether a new web-based interactive educational programme results in a higher chance of naturally conceiving an ongoing pregnancy within 6 months as compared with EM. METHODS AND ANALYSIS: A multicentre RCT with cost-effectiveness analysis will include heterosexual couples diagnosed with (relatively) unexplained subfertility and a good prognosis in Dutch and Belgian secondary or tertiary fertility clinics. Couples will be randomised between 6 months of EM and 6 months of the Pleasure&Pregnancy-programme. This new web-based interactive educational programme includes eight progressive modules of information (on the biology of conception and pleasurable sex) and sensate focus, couple communication and mindfulness exercises. Couples are offered interaction with their coaches via email and can take part in three moderated chat sessions with peers. The primary outcome of this RCT is the probability of naturally conceiving an ongoing pregnancy within 6 months after randomisation. Secondary outcomes include time-to-pregnancy, live birth rate, costs, sexual functioning and personal and relational well-being. Analysis will be according to intention to treat. ETHICS AND DISSEMINATION: This study has been approved by the Medical Ethical Committees of the Academic Medical Centre (the Netherlands) and the Leuven University Hospital (Belgium). The findings of this RCT will be disseminated through presentations at international scientific meetings and peer-reviewed publications. TRAIL REGISTRATION NUMBER: NTR5709; Pre-results.
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Instrução por Computador , Fertilização/fisiologia , Infertilidade/terapia , Atenção Plena , Aconselhamento Sexual , Conduta Expectante , Adulto , Feminino , Humanos , Infertilidade/fisiopatologia , Masculino , Estudos Multicêntricos como Assunto , Países Baixos/epidemiologia , Educação de Pacientes como Assunto , Participação do Paciente , Prazer/fisiologia , Gravidez , Taxa de Gravidez , Avaliação de Programas e Projetos de Saúde , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Recent progress in the formation of artificial gametes, i.e. gametes generated by manipulation of their progenitors or of somatic cells, has led to scientific and societal discussion about their use in medically assisted reproduction (MAR). Artificial gametes could potentially help infertile men and women but also post-menopausal women and gay couples conceive genetically related children. This systematic review aimed to provide insight in the progress of biological research towards clinical application of artificial gametes. METHODS: The electronic database 'Medline/Pubmed' was systematically searched with medical subject heading (MesH) terms, and reference lists of eligible studies were hand searched. Studies in English between January 1970 and December 2013 were selected based on meeting a priori defined starting- and end-points of gamete development, including gamete formation, fertilization and the birth of offspring. For each biologically plausible method to form artificial gametes, data were extracted on the potential to generate artificial gametes that might be used to achieve fertilization and to result in the birth of offspring in animals and humans. RESULTS: The systematic search yielded 2424 articles, and 70 studies were included after screening. In animals, artificial sperm and artificial oocytes generated from germline stem cells (GSCs), embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs) have resulted in the birth of viable offspring. Also in animals, artificial sperm and artificial oocytes have been generated from somatic cells directly, i.e. without documentation of intermediate stages of stem- or germ cell development or (epi)genetic status. Finally, although the subsequent embryos showed hampered development, haploidization by transplantation of a somatic cell nucleus into an enucleated donor oocyte has led to fertilized artificial oocytes. In humans, artificial sperm has been generated from ESCs and iPSCs. Artificial human oocytes have been generated from GSCs, ESCs and somatic cells (without documentation of intermediate stages of stem- or germ cell development). Fertilization of a human artificial oocyte after haploidization by transplantation of a somatic cell nucleus into an enucleated donor oocyte was also reported. Normal developmental potential, epigenetic and genetic stability and birth of children has not been reported following the use of human artificial gametes. In animals, artificial oocytes from a male have been created and fertilized and artificial sperm from a female has been fertilized and has resulted in the birth of viable offspring. In humans, artificial sperm has been generated from female iPSCs. To date, no study has reported the birth of human offspring from artificial gametes. CONCLUSION: Our systematic review of the literature indicated that in animals live births have already been achieved using artificial gametes of varying (cell type) sources. Although experimental biological research is progressing steadily towards future clinical application, data on functionality, safety and efficiency of (human) artificial gametes are still preliminary. Although defining artificial gametes by start- and end-points limited the number of included studies, the search resulted in a clear overview of the subject. Clinical use of artificial gametes would expand the treatment possibilities of MAR and would have implications for society. Before potential clinical use, the societal and ethical implications of artificial gametes should be reflected on.
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Células-Tronco Embrionárias/citologia , Engenharia Genética/métodos , Infertilidade/terapia , Oócitos/citologia , Espermatozoides/citologia , Animais , Diferenciação Celular , Núcleo Celular/fisiologia , Feminino , Fertilização , Humanos , Masculino , Técnicas de Transferência Nuclear , Oócitos/metabolismo , Células-Tronco Pluripotentes/citologia , Técnicas de Reprodução Assistida , Espermatozoides/metabolismo , Doadores de TecidosRESUMO
BACKGROUND: Recent progress in the formation of artificial gametes, i.e. gametes generated from progenitors or somatic cells, has led to scientific and societal discussion about their use in medically assisted reproduction. In animals, live births have already been achieved using artificial gametes of varying (cell type) sources and biological research seems to be progressing steadily toward clinical application in humans. Artificial gametes could potentially help not only infertile heterosexual couples of reproductive age of which one or both partners lacks functional gametes, but also post-menopausal women and same-sex couples, to conceive a child who will be genetically related to them. But as clinical application of these new technologies may have wider societal consequences, a proactive consideration of the possible impact seems timely and important. This review aims to contribute to this by providing a systematic overview of the potential consequences of clinical application of artificial gametes anticipated by different stakeholders. METHODS: The electronic database 'Medline/Pubmed' was systematically searched with medical subject heading terms (MesH) for articles published in English between January 1970 and December 2013. Articles were selected based on eligibility and reference lists of eligible studies were hand searched. The reported potential consequences of clinical application of artificial gametes were extracted from the articles and were grouped into categories by content analysis. Per category, we noted which stakeholders referred to which potential consequences, based on author affiliations and, if applicable, study participants. RESULTS: The systematic search yielded 2424 articles, and 84 studies were included after screening. Nine positive consequences, 21 specific consequences requiring consideration and 22 recommendations referring to clinical application of artificial gametes were documented. All positive consequences, consequences requiring consideration and recommendations could be categorized under the following eight objectives to be safeguarded during clinical application of artificial gametes: (i) timing the implementation of new treatments correctly, (ii) meeting 'plausible demands of patients', (iii) improving and safeguarding public health, (iv) promoting the progress of medical science in the interest of future patients, (v) providing treatments that are morally acceptable for the general public, (vi) controlling medical practice, (vii) offering treatments that allow acquisition of informed consent and (viii) funding treatments fairly. Professionals specialized in biomedical science, science journalists and professionals specialized in ethics all addressed these eight objectives on artificial gametes, whereas professionals specialized in law or political science addressed seven objectives. Although one study reported on the perspective of parents of under-aged patients on three objectives, the perspectives of patients themselves were not reported by the reviewed literature. CONCLUSION: Of course, clinical introduction of artificial gametes should only be considered on the basis of reassuring outcomes of appropriate preclinical effectiveness and safety studies. In addition, potential users' views on the desirability and acceptability of artificial gametes should be studied before clinical introduction. A societal debate including all stakeholders is needed to determine the relative importance of all arguments in favor of and against the introduction of artificial gametes into clinical practice. More broadly, establishing pre-implementation processes for new medical techniques is relevant for all fields of medicine.
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Engenharia Genética/métodos , Micromanipulação/métodos , Oócitos/citologia , Técnicas de Reprodução Assistida/ética , Espermatozoides/citologia , Células-Tronco Embrionárias/citologia , Humanos , Masculino , Células-Tronco Pluripotentes/citologiaRESUMO
OBJECTIVE: Acute fertility preservation for women is an interdisciplinary treatment that requires adequate information provision and early referral. This quality management project aimed to improve fertility preservation care by using a practical tool: Strengths, Weaknesses, Opportunities and Threats (SWOT) analysis. STUDY DESIGN: Quality management project was executed between May 2011 and July 2013. This project has been executed in a university affiliated IVF-clinic in cooperation with two oncological sites and used a four-step strategy: (1) monitoring baseline referral process, (2) exploring baseline fertility preservation program by Strengths, Weaknesses, Opportunities and Threats' (SWOT)-analysis, (3) setting up a new fertility preservation program and (4) evaluating the new fertility preservation program by means of SWOT-analysis. RESULTS: During the three-months monitoring period, fertility preservation was requested for a total of 126 women. The mean age of the women was 33.8 years old (range 1-42 years old). Most requests came from women who wanted to cryopreserve oocytes because of age-related decline of fertility (n=90; 71%). Most requests for acute fertility preservation concerned women with breast cancer (n=16; 57%). Information leaflets and pre-consultation questionnaires for women improved the quality of first fertility preservation consultation as evaluated by final SWOT-analysis. Collaboration with oncological centres and information about fertility preservation improved the referral process. CONCLUSIONS: SWOT-analysis proved useful for setting up a new fertility preservation-program and can be recommended as a tool to improve the management and organisation of new types of reproductive care.
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Preservação da Fertilidade/métodos , Fertilização in vitro , Adolescente , Adulto , Criança , Pré-Escolar , Criopreservação , Feminino , Humanos , Lactente , Oócitos , Encaminhamento e ConsultaRESUMO
The attitude of patients with reproductive disorders regarding the use of nonhuman primates (NHPs) in preclinical reproductive research and its determinants was examined. A survey was conducted on 299 patients with fertility problems and/or endometriosis in a European fertility center (RR = 80%). The main outcome measure was the attitude toward reproductive research on NHPs. In total, 70.6% accept and 29.4% reject NHP research. Factors significantly positively related to acceptance are confidence in researchers and previous pregnancy. Factors significantly negatively related to acceptance include having a pet, membership of a nature organization, vegetarian, and having lived abroad. To the best of our knowledge, this study is the first on patients' perspective on NHP research. The majority of the patients accept reproductive research on NHPs. Trust in researchers was the most important positively related factor; therefore, researchers are advised to actively try to gain the trust of patients and the public.