Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)
1 de febrero de 2022 actualizado por: Organon and Co
Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 38819
To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), in order to estimate the cumulative pregnancy rate for each treatment group.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a follow-up protocol to collect the outcome of frozen-thawed embryo transfer cycles, performed after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), to enable estimation of the cumulative pregnancy rate for each treatment group.
Tipo de estudio
De observación
Inscripción (Actual)
344
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 36 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra de probabilidad
Población de estudio
Women from whom embryos have been cryopreserved in Base Trial P05787 (NCT00696800).
Descripción
Inclusion Criteria:
- Participants from whom embryos have been cryopreserved in Base Trial P05787 (NCT00696800), of which at least one embryo is thawed for use in a subsequent FTET cycle;
- Able and willing to give informed consent.
Exclusion Criteria:
- None
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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150 µg Corifollitropin Alfa
Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa (Org 36286) on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG).
Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm.
On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses.
Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
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En el día 5 de estimulación, se inició una inyección SC diaria de 0,25 mg, que continuó hasta el día de hCG incluido.
Cuando se observaron 3 folículos >= 17 mm por USS, se administró una dosis única de 10.000 UI/USP hCG; o, para aquellas con riesgo de síndrome de hiperestimulación ovárica (OHSS), una dosis más baja de 5000 UI/USP
El día de la OPU, se inició el soporte de la fase lútea mediante la administración de progesterona micronizada de al menos 600 mg/día por vía vaginal, o al menos 50 mg/día por vía intramuscular (IM), que se continuó durante al menos 6 semanas o hasta la menstruación.
On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.
Identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen.
Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.
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200 IU RecFSH
Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG.
Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm.
On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
En el día 5 de estimulación, se inició una inyección SC diaria de 0,25 mg, que continuó hasta el día de hCG incluido.
Cuando se observaron 3 folículos >= 17 mm por USS, se administró una dosis única de 10.000 UI/USP hCG; o, para aquellas con riesgo de síndrome de hiperestimulación ovárica (OHSS), una dosis más baja de 5000 UI/USP
El día de la OPU, se inició el soporte de la fase lútea mediante la administración de progesterona micronizada de al menos 600 mg/día por vía vaginal, o al menos 50 mg/día por vía intramuscular (IM), que se continuó durante al menos 6 semanas o hasta la menstruación.
From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.
Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
Pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa.
On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)
Periodo de tiempo: Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial
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An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed by live birth.The cumulative ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base Trial P05787 (NCT00696800), or after one or more FTET cycles in follow-up Trial P05716 following cryopreservation, divided by the total number of participants that started treatment in base Trial P05787 (NCT00696800).
Participants who did not have cryopreserved embryos, or embryo transfers in the FTET cycle(s), were considered 'not pregnant'.
|
Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy
Periodo de tiempo: After one or more FTET cycles, up to day of miscarriage (up to 1 year)
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Miscarriages were calculated per clinical pregnancy, meaning the presence of at least one gestational sac or confirmed by live birth.
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After one or more FTET cycles, up to day of miscarriage (up to 1 year)
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Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy
Periodo de tiempo: After one or more FTET cycles, up to day of miscarriage (up to 1 year)
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Miscarriages were calculated per vital pregnancy, meaning the presence of at least one fetus with heart activity.
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After one or more FTET cycles, up to day of miscarriage (up to 1 year)
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Percentage of Participants in Follow up Trial With an Ectopic Pregnancy
Periodo de tiempo: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
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An ectopic pregnancy is where the embryo implants outside the uterus.
Ectopic pregnancies were calculated per total number of participants started in FTET.
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After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
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Percentage of Participants in Follow up Trial With a Clinical Pregnancy
Periodo de tiempo: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
|
A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth.
Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.
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After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
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Percentage of Participants in Follow up Trial With a Vital Pregnancy
Periodo de tiempo: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
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A vital pregnancy is the presence of at least one fetus with heart activity.
Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.
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After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
|
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Percentage of Participants in Follow up Trial With an Ongoing Pregnancy
Periodo de tiempo: After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)
|
An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth.
Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.
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After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
19 de abril de 2006
Finalización primaria (Actual)
19 de mayo de 2009
Finalización del estudio (Actual)
31 de mayo de 2009
Fechas de registro del estudio
Enviado por primera vez
18 de junio de 2008
Primero enviado que cumplió con los criterios de control de calidad
19 de junio de 2008
Publicado por primera vez (Estimar)
20 de junio de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de febrero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
1 de febrero de 2022
Última verificación
1 de febrero de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P05716
- 38831 (Otro identificador: Organon)
- 2004-004773-28 (Número EudraCT)
- MK-8962-009 (Otro identificador: Merck)
Plan de datos de participantes individuales (IPD)
Datos del estudio/Documentos
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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