Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 3 de 3
Filtrar
Mais filtros











Intervalo de ano de publicação
1.
BMC Pregnancy Childbirth ; 20(1): 333, 2020 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-32473654

RESUMO

BACKGROUND: The effects of endometrial scratching (ES) on embryo implantation have been studied for many years. Several studies have shown better outcomes when performed on patients undergoing intrauterine insemination and in vitro fertilization (IVF) cycles, but many other reports have not been able to find these differences. As far as cycles with donor eggs are concerned, reported evidence is scarce. Our aim in this trial is to determine if ES is useful for those patients undergoing IVF cycles with donor eggs, in order to assure a greater homogeneity in embryo quality and endometrial preparation. METHODS: This single centre randomized controlled trial will include patients undergoing an egg donation cycle, meeting the inclusion criteria and who accept to participate in the study. Once informed consent is signed, patients will be randomly allocated to the study arm (group A) and then receive ES in the luteal phase of the cycle prior to embryo transfer, or the control arm (group B) without any intervention. All cycle data will be collected and analyzed to obtain the clinical pregnancy and the live birth rates in the two groups. DISCUSSION: Several studies have tried to determine the effectiveness of an ES in IVF cycles, but it is still unclear due to the heterogeneity of these reports. The aim of this study is to determine if there are differences in clinical pregnancy rate and live birth rate in egg donor cycles, when comparing an ES performed in the preceding luteal phase versus no intervention, given that embryo quality and endometrial preparation protocols will be comparable. TRIAL REGISTRATION: Ethical approval of version 2.0 of this trial was obtained on the 13th January 2017. It was retrospectively registered on the 5th April 2017 as the ENDOSCRATCH Trial (NCT03108157) in ClinicalTrials.gov.


Assuntos
Coeficiente de Natalidade , Implantação do Embrião , Transferência Embrionária/métodos , Endométrio/patologia , Fertilização in vitro/métodos , Nascido Vivo , Fase Luteal , Adolescente , Adulto , Biópsia , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Gravidez , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto Jovem
2.
Rev. iberoam. fertil. reprod. hum ; 34(1): 64-73, ene.-mar. 2017. tab, graf
Artigo em Inglês | IBECS | ID: ibc-162675

RESUMO

BACKGROUND: Since the 1990s recombinant human FSH (r-hFSH), such as Gonal-f® and Puregon®, have been in widespread use for fertility treatment [1]. More recently Bemfola®, biosimilar to r-hFSH, has been introduced with similar efficacy and safety to Gonal-f® [2], but delivered in a novel, innovative injector pen system (Reddot design award 2011). The Bemfola® pen (BP) is a single-use, disposable pen available in five different presentations (i.e., 75IU, 150IU, 225IU, 300IU and 450IU), each of which provides a range of doses that it can deliver. Non-compliance to hormonal treatment regimens might be a critical issue to reach therapeutic goals. The use of pens by patients is often limited by factors such as fear of injection, but can be also related to the device itself [3-6]. Therefore, easy-to-use devices may also positively influence physicians» hormonal prescribing habits and patient's compliance. Accordingly, this user acceptance study aimed to assess the use of the Bemfola® pen in a population of potential users with regard to the easiness and convenience of handling of the Bemfola® Pen in comparison to the Gonal-f® pen and Puregon® pen. Material and Methods Randomised and single-blind study with three-arm user test. The investigation was conducted in females who considered undergoing hormonal treatment for the first time (naïve) and who were considering to start an IVF or donor egg treatment cycle. A total of 10 centers from Spain participated in this investigation. This study of user acceptance included 460 females qualifying for potential patients considering a therapy with follicle stimulating hormone. Users received the three pens in a randomized, consecutive sequence, completed for each of the pen one questionnaire (same for all 3 pens) and thereafter completed a concluding questionnaire comparing the handling, convenience and indicating their preference among the 3 pens. No self-injections were performed and an application pad for injections was used. Results The Bemfola® pen showed the highest scorings and strong preferences in all pen features assessed and achieved the highest proportion of best choice compared to both the Gonal-f® and Puregon®. pen. Conclusions The results indicated significant preferences of women, who intended to undergo a hormonal treatment, for the Bemfola® pen compared to both the Puregon® pen and the Gonal-f® pen


ANTECEDENTES: Desde la década de los noventa, la hormona foliculoestimulante humana recombinante (hFSH-r) como Gonal-f® y Puregon®, se ha utilizado ampliamente en el tratamiento de la fertilidad [1]. Más recientemente se ha introducido Bemfola®, biosimilar de la hFSH-r con eficacia y seguridad similar a Gonal-f® [2], pero desarrollada con un innovador sistema de pluma inyectora (premio de diseño Reddot, 2011). Bemfola® es una pluma precargada desechable de un solo uso, disponible en cinco presentaciones diferentes (75 UI, 150 UI, 225 UI, 300 UI y 450 UI), cada una de las cuales proporciona un rango de dosis determinado. El no-cumplimiento de las pautas de tratamiento hormonal es un problema fundamental en la consecución de los objetivos terapéuticos. El uso de plumas por las pacientes se ve a menudo limitado por el miedo a la inyección e incluso relacionado con el propio dispositivo [3-6]. Por tanto, los dispositivos de fácil uso pueden influir positivamente tanto en los hábitos de prescripción de terapias hormonales de los médicos como en el cumplimiento del paciente. En consecuencia, el objetivo de este estudio consiste en evaluar el uso de Bemfola® en una población de usuarias potenciales con respecto a la facilidad, y conveniencia en su manejo en comparación con las plumas Gonal-f® y Puregon®. Material y Métodos Estudio aleatorizado y simple ciego de tres ramas de tratamiento. Esta investigación se llevó a cabo en mujeres sin tratamiento previo que estaban considerando bien iniciar un ciclo de FIV o bien ser donantes de ovocitos. En este estudio participaron 10 centros de fertilidad de España. Se incluyeron 460 mujeres cualificadas para ser «pacientes potenciales de terapia hormonal con hormona foliculoestimulante humana recombinante» Las usuarias recibieron las tres plumas (Bemfola®, Gonal-f® y Puregon®) en una secuencia aleatoria y consecutiva, y completaron un cuestionario idéntico por cada una de las plumas, y un cuestionario de conclusión con el fin de comparar el manejo, la comodidad y la preferencia de las tres plumas. En ningún caso se realizaron auto-inyecciones y en su lugar se utilizó una almohadilla de aplicación de inyecciones. Resultados La pluma Bemfola® mostró la mayor puntuación y elevadas preferencias en todas las características evaluadas, y alcanzó la mayor proporción de «mejor» opción en comparación con la pluma Gonal-f® y la pluma Puregon®. Conclusiones Los resultados mostraron preferencias significativas de mujeres que tenían la intención de someterse a un tratamiento hormonal, para la pluma Bemfola® en comparación con las plumas Gonal-f® y Puregon®


Assuntos
Humanos , Feminino , Indução da Ovulação/métodos , Fertilização in vitro , Hormônio Foliculoestimulante/administração & dosagem , Inseminação Artificial Heteróloga , Seleção do Doador , Satisfação do Paciente , Injeções Subcutâneas
3.
Rev. iberoam. fertil. reprod. hum ; 33(3): 42-51, jul.-sept. 2016. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-156072

RESUMO

ANTECEDENTES: Desde la década de los noventa, la hormona foliculoestimulante humana recombinante (hFSH-r) como Gonal-f® y Puregon®, se ha utilizado ampliamente en el tratamiento de la fertilidad [1]. Más recientemente se ha introducido Bemfola®, biosimilar de la hFSH-r con eficacia y seguridad similar a Gonal-f® [2], pero desarrollada con un innovador sistema de pluma inyectora (premio de diseño Reddot, 2011). Bemfola® es una pluma precargada desechable de un solo uso, disponible en cinco presentaciones diferentes (75 UI, 150 UI, 225 UI, 300 UI y 450 UI), cada una de las cuales proporciona un rango de dosis determinado. El no-cumplimiento de las pautas de tratamiento hormonal es un problema fundamental en la consecución de los objetivos terapéuticos. El uso de plumas por las pacientes se ve a menudo limitado por el miedo a la inyección e incluso relacionado con el propio dispositivo [3-6]. Por tanto, los dispositivos de fácil uso pueden influir positivamente tanto en los hábitos de prescripción de terapias hormonales de los médicos como en el cumplimiento del paciente. En consecuencia, el objetivo de este estudio consiste en evaluar el uso de Bemfola® en una población de usuarias potenciales con respecto a la facilidad, y conveniencia en su manejo en comparación con las plumas Gonal-f® y Puregon®. Material y MÉTODOS: Estudio aleatorizado y simple ciego de tres ramas de tratamiento. Esta investigación se llevó a cabo en mujeres sin tratamiento previo que estaban considerando bien iniciar un ciclo de FIV o bien ser donantes de ovocitos. En este estudio participaron 10 centros de fertilidad de España. Se incluyeron 460 mujeres cualificadas para ser «pacientes potenciales de terapia hormonal con hormona foliculoestimulante humana recombinante». Las usuarias recibieron las tres plumas (Bemfola®, Gonal-f® y Puregon®) en una secuencia aleatoria y consecutiva, y completaron un cuestionario idéntico por cada una de las plumas, y un cuestionario de conclusión con el fin de comparar el manejo, la comodidad y la preferencia de las tres plumas. En ningún caso se realizaron auto-inyecciones y en su lugar se utilizó una almohadilla de aplicación de inyecciones. RESULTADOS: La pluma Bemfola® mostró la mayor puntuación y elevadas preferencias en todas las características evaluadas, y alcanzó la mayor proporción de «mejor» opción en comparación con la pluma Gonal-f® y la pluma Puregon®. CONCLUSIONES: Los resultados mostraron preferencias significativas de mujeres que tenían la intención de someterse a un tratamiento hormonal, para la pluma Bemfola® en comparación con las plumas Gonal-f® y Puregon®


BACKGROUND: Since the 1990s recombinant human FSH (r-hFSH), such as Gonal-f® and Puregon®, have been in widespread use for fertility treatment [1]. More recently Bemfola® has been introduced with familiar efficacy and safety to Gonal-f® [2], but delivered in a novel, innovative injector pen system (Reddot design award 2011). The Bemfola® pen (BP) is a singleuse, disposable pen available in five different presentations (i.e., 75IU, 150IU, 225IU, 300IU and 450IU), each of which provides a range of doses that it can deliver. Non-compliance to hormonal treatment regimens might be a critical issue to reach therapeutic goals. The use of pens by patients is often limited by factors such as fear of injection, but can be also related to the device itself [3-6]. Therefore, easy-to-use devices may also positively influence physicians' hormonal prescribing habits and patient's compliance. Accordingly, this user acceptance study aimed to assess the use of the Bemfola® pen in a population of potential users with regard to the easiness and convenience of handling of the Bemfola® Pen in comparison to the Gonal-f® pen and Puregon® pen. Material and methods Randomised and single-blind study with three-arm user test. The investigation was conducted in females who considered undergoing hormonal treatment for the first time (naïve) and who were considering to start an IVF or donor egg treatment cycle. A total of two 10 centres from Spain participated in this investigation. This study of user acceptance included 460 females qualifying for potential patients considering a therapy with follicle stimulating hormone. Users received the three pens in a randomized, consecutive sequence, complete for each of the pen one questionnaire (same for all 3 pens) and thereafter complete a concluding questionnaire comparing the handling, convenience and indicating their preference among the 3 pens. No self-injections were performed and an application pad for injections was used. Results The Bemfola® pen showed the highest scorings and strong preferences in all pen features assessed and achieved the highest proportion of best choice compared to both, the Gonal-f® and Puregon® pen. Conclusions The results indicated significant preferences of women, who intended to undergo a hormonal treatment, for the Bemfola® pen compared to both the Puregon® pen and the Gonal-f® pen


Assuntos
Humanos , Masculino , Feminino , Doação de Oócitos , Recuperação de Oócitos/métodos , Recuperação de Oócitos , Técnicas de Maturação in Vitro de Oócitos/métodos , Hormônio Foliculoestimulante/uso terapêutico , Receptores do FSH/uso terapêutico , Inquéritos e Questionários , Administração Intravenosa , Resultado do Tratamento
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA