PRP Improves Blastocyst Formation in ICSI Cycles (PRP ICSI SOAT)
5 de mayo de 2026 actualizado por: Binarwan Halim, Stella Maris Women and Children Hospital
Efficacy of Platelet-rich Plasma on Blastocyst Formation in ICSI Cycles Involving Low-quality Sperm: A Randomised Study
The goal of this clinical trial is to learn if platelet rich plasma (PRP) works to improve embryo development rates and embryo quality in IVF cycles, involving male adult patients with severe sperm disorders.
The main questions it aims to answer are:
- Does PRP improve sperm quality of male adult patients undergoing IVF?
- Does PRP improve embryo development and embryo quality of the IVF patients?
Researchers will compare embryos from IVF patients treated with PRP to those not treated with PRP to see if PRP improves embryo development and embryo quality.
Participants will:
- Provide semen sample for IVF
- Provide blood sample for PRP preparation
- Have PRP obtained from their blood added to their sperm sample
Descripción general del estudio
Estado
Terminado
Condiciones
- Desarrollo embrionario
- Blastocisto
- Plasma rico en plaquetas
- Calidad del esperma
- Calidad embrionaria
- Plasma Rico en Plaquetas (PRP)
- Parámetros espermáticos en hombres fértiles e infértiles
- Trastornos de los espermatozoides
- Blastocistos
- Parámetros embriológicos
- Blastocyst FIV
- Calidad del Blastocisto
- Severe Oligoasthenoteratozoospermia
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
66
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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North Sumatra
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Medan, North Sumatra, Indonesia, 20152
- Halim Fertility Center, RSIA Stella Maris lantai 5, Jl. Samanhudi No.20, J A T I, Kec. Medan Maimun, Kota Medan, Sumatera Utara 20152
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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
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- sperm concentration of less than five million/mL;
- total sperm motility < 42%;
- sperm normal morphology of less than four percent;
- provided informed consent to participate in the study
Exclusion Criteria:
- leukospermia;
- a history of HIV, hepatitis, or other reproductive tract infections;
- a history of utilising drugs or therapies within the past three months, such as antibiotics, radiotherapy, chemotherapy, psychiatric medications, or anabolic steroids;
- a history of fever within the past three months;
- a history of testicular carcinoma;
- using a second ejaculate sample for ICSI;
- using a cryopreserved semen sample for ICSI;
- a history of retrograde ejaculation;
- a history of coagulopathy
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
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: PPR
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Platelet-rich plasma (PRP) will be prepared from autologous blood collected from each participant.
The blood sample will undergo centrifugation at 1400 rpm for 15 minutes to separate and concentrate the platelet-rich fraction.
The resulting PRP will then be isolated and added to the participant's sperm sample for use in the IVF procedure.
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Sin intervención: Non-PRP
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Blastocyst formation rate (%)
Periodo de tiempo: From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Blastocyst formation rate is defined as the proportion of fertilised oocytes that successfully develop into blastocysts by Day 5 of embryo culture.
It is calculated as the number of embryos reaching the blastocyst stage on Day 5 divided by the total number of normally fertilised oocytes (2 pronuclei, 2PN), expressed as a percentage.
Embryo development is assessed using standard morphological criteria under microscopy, and only embryos meeting established blastocyst-stage characteristics are included in the numerator.
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From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fertilisation rate (%)
Periodo de tiempo: From enrollment to fertilisation of the embryo (day 1). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Fertilisation rate refers to the percentage of mature eggs that are successfully fertilised after being combined with sperm in the laboratory.
It is calculated by dividing the number of eggs that show normal signs of fertilisation by the total number of mature eggs used for insemination, then multiplying by 100.
Normal fertilisation is identified by the presence of two distinct structures inside the egg when examined under a microscope approximately 16-18 hours after insemination.
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From enrollment to fertilisation of the embryo (day 1). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Cleavage rate (%)
Periodo de tiempo: From enrollment to cleavage development (day 3). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Cleavage rate refers to the percentage of fertilised eggs that undergo early cell division during the first 3 days of embryo development.
It is calculated by dividing the number of fertilised eggs that successfully divide into two or more cells by the total number of normally fertilised eggs, then multiplying by 100.
Embryos are observed under a microscope to confirm cell division and early development.
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From enrollment to cleavage development (day 3). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Good-quality blastocyst (%)
Periodo de tiempo: From enrollment to blastocyst development (days 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Good quality blastocyst refers to the proportion of embryos that develop into blastocysts by Day 5 and meet predefined criteria for high quality based on their appearance under a microscope.
It is calculated by dividing the number of blastocysts classified as good quality by the total number of blastocysts formed, then multiplying by 100.
Blastocyst quality is assessed using standard grading systems that evaluate the degree of expansion, the appearance of the inner cell mass and the outer cell layer.
Only blastocysts meeting the predefined criteria for good quality are included.
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From enrollment to blastocyst development (days 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Fair-quality blastocyst (%)
Periodo de tiempo: From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Fair quality blastocyst refers to the proportion of embryos that develop into blastocysts by Day 5 and meet predefined criteria for intermediate (fair) quality based on their appearance under a microscope.
It is calculated by dividing the number of blastocysts classified as fair quality by the total number of blastocysts formed, then multiplying by 100.
Blastocyst quality is assessed using standard grading systems that evaluate how expanded the blastocyst is, the appearance of its inner cell mass and outer cell layer.
Only blastocysts meeting the predefined criteria for fair quality are included.
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From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Poor-quality blastocyst (%)
Periodo de tiempo: From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Poor quality blastocyst refers to the proportion of embryos that develop into blastocysts by Day 5 but are classified as low quality based on their appearance under a microscope.
It is calculated by dividing the number of blastocysts assessed as poor quality by the total number of blastocysts formed, then multiplying by 100.
Blastocyst quality is evaluated using standard grading criteria that consider the degree of expansion, the appearance of the inner cell mass and the outer cell layer.
Blastocysts that show limited expansion or irregular or poorly defined structures are classified as poor quality.
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From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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)
1 de enero de 2023
Finalización primaria (Actual)
30 de agosto de 2023
Finalización del estudio (Actual)
30 de diciembre de 2023
Fechas de registro del estudio
Enviado por primera vez
5 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de mayo de 2026
Publicado por primera vez (Actual)
12 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de mayo de 2026
Última verificación
1 de enero de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 608.1/Dir/RSIA.SM/XII/2022
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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