Communication With in Vitro Fertilization (IVF) Patients About Risks
Improving Communication With IVF Patients About Risks Such as Multiple Births
The primary objective of this trial is to determine whether written educational materials plus brief education by telephone will help patients better understand and participate in the decision on how many embryos to transfer to the uterus during treatment of infertility with in vitro fertilization (IVF). The main study hypothesis is that women and men who receive the study's educational intervention will experience favorable changes in knowledge and beliefs about benefits, susceptibility and severity of multiple gestation that impact decisions about the number of embryos to transfer. Secondary objectives are to understand patient beliefs, knowledge and information preferences regarding other possible risks of IVF, to compare perception of IVF-related risks to familiar risks that are included in routine preconception health promotion, and during IVF, and to prepare couples to manage IVF-related obstetrical risks when they make the transition to prenatal care after becoming pregnant.
Medical Treatment Coverage: None, this study does not provide any monetary contribution to medical treatment
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The long-term objective of this research is to improve patient understanding of the known and strongly suspected risks from treating infertility with assisted reproductive technologies such as in vitro fertilization (IVF). During IVF, when more embryos are transferred to the uterus, the risk of pregnancy with multiple fetuses increases. In addition, single infants conceived with IVF are at greater risk for low birth weight. This study will promote behaviors that may reduce these risks. One in 3 women who completes a pregnancy conceived with assisted reproductive technologies such as IVF delivers multiples, and these treatments produce over 12,000 multiple birth deliveries annually in the United States. This study will lead to a better understanding of the most effective ways to counsel IVF patients about the embryo transfer decision. This study will also help define how to prepare IVF patients to work most effectively with their prenatal care team to manage IVF-related obstetrical risks.
Medical Treatment Coverage: None, this study does not provide any monetary contribution to medical treatment
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kansas
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Wichita, Kansas, Estados Unidos, 67214
- University of Kansas School of Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- At least 18 years of age
Exclusion Criteria:
- Using a gestational carrier in the current cycle of IVF
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Intervention
Written materials, telephone based education
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4 new written materials, 15-20 minute educational session by telephone
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Otro: Comparison
Written materials
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2 written materials available on public website
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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questionnaire assessing knowledge, risk perception, self efficacy and preferences, interview about risk perception and decision making
Periodo de tiempo: Prior to IVF treatment cycle, 8 weeks
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Prior to IVF treatment cycle, 8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Adoption of healthy preconception behavior, self-efficacy for addressing IVF related obstetrical factors
Periodo de tiempo: Prior to IVF treatment cycle, 8 weeks
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Prior to IVF treatment cycle, 8 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Linda Frazier, MD, University of Kansas School of Medicine-Wichita
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 220060957
- 1R21HD053459-01A1 (Subvención/contrato del NIH de EE. UU.)
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