- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01287273
The Impact of Early Embryos Incubation on Pregnancy Rate in IVF (IVF-2010)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
It has been common practice to cryopreserve surplus embryos achieved during IVF treatment or in other situation that embryos are to be preserved for other situations such as suspected ovarian hyper stimulation syndrome, fertility preservation or patient request.
Embryos are usually frozen on day 2, 3 or day 5-6 at the Blastocyst stage. At the time that thawing is planned, patients' cycle is synchronized and prepared either with hormonal treatment or at the natural cycle.
Not all embryos will always survive the thawing and sometimes they will all degenerate.
Embryos that survive the thawing procedure are assessed and replaced on the day of the thaw or left overnight for better selection and will be replaced only if they continue to divide in vitro.
The advantage of embryo transfer on the day of thaw is that embryo exposure in culture is shortened and embryo selection will be occurring in the womb. On the other hand, overnight incubation may avoid transferring embryos that potentially are not able to divide and are biologically not viable.
Although both attitudes are practiced in different IVF centers, at present there are no prospective randomized studies that have been conducted to advise which intervention is better in terms of pregnancy rates.
The purpose of the present study is to assess which technique will result in better pregnancy rates.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Haifa, Israel, 34362
- Reclutamiento
- Carmel Medical Center
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Contacto:
- Martha Dirnfeld, MD
- Número de teléfono: 9724 8250335
- Correo electrónico: dirnfeld_martha@clalit.org.il
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Contacto:
- Shirly Lahav-Baratz, D.Sc
- Número de teléfono: 9724 8250118
- Correo electrónico: lahav_shirly@clalit.org.il
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Investigador principal:
- Martha Dirnfeld, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
660 IVF patients. patients who are candidates for embryo cryopreservation cycle will be offered to participate in the present prospective randomized study.
After detailed verbal and written explanation on the study protocol they will sign an informed consent and then randomized to 2 groups.
Descripción
Inclusion Criteria:
- IVF patient who have thawed embryo transfer and can read understand and sigh on informed consent
Exclusion Criteria:
- IVF patient who have thawed embryo transfer and can not read understand and sigh on informed consent/ also those whos embryos will not survive freezing- thawing
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Group A
Transfer at the day of embryo thawing
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Group B
Transfer of thawed embryos 24-72 hours post thawing
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pregnancy as measured by blood test for beta hCG
Periodo de tiempo: 12 days following embryos transfer
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as the usual routine, the women come on day 12 or 13 following embryo transfer to pur IVF unit to get blood teat for beta hCG.
When the result show that the beta hCG is above 5 unit/liter we consider it as positive result and the patients is invited for additional blood test 2 days later/
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12 days following embryos transfer
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Delivery of baby
Periodo de tiempo: 9 mounth after embryos transfer
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We are routinely report to the Israeli ministry of health all the children who were born from our treatment.
In this study we will calculate the number of children per thawed embryo transfer.
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9 mounth after embryos transfer
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Martha Dirnfeld, MD, Carmel Medical Center IVF Unit
Publicaciones y enlaces útiles
Publicaciones Generales
- Lahav-Baratz S, Koifman M, Shiloh H, Ishai D, Wiener-Megnazi Z, Dirnfeld M. Analyzing factors affecting the success rate of frozen-thawed embryos. J Assist Reprod Genet. 2003 Nov;20(11):444-8. doi: 10.1023/b:jarg.0000006705.46147.a2.
- Lahav-Baratz S, Shiloh H, Koifman M, Kraiem Z, Wiener-Megnazi Z, Ishai D, Dirnfeld M. Early embryo-endometrial signaling modulates the regulation of matrix metalloproteinase-3. Fertil Steril. 2004 Oct;82 Suppl 3:1029-35. doi: 10.1016/j.fertnstert.2004.06.026.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
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
Otros números de identificación del estudio
- CMC-10-0010-CTIL
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