PRP Improves Blastocyst Formation in ICSI Cycles (PRP ICSI SOAT)
5 de maio de 2026 atualizado 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
Visão geral do estudo
Status
Concluído
Condições
- Desenvolvimento do embrião
- Blastocisto
- Plasma rico em plaquetas
- Qualidade do esperma
- Qualidade do embrião
- Plasma rico em plaquetas (PRP)
- Parâmetros do esperma em homens férteis e inférteis
- Distúrbios do Espermatazoa
- Blastocistos
- Parâmetros Embriológicos
- BLASTOCISTA FIV
- Qualidade do Blastocisto
- Severe Oligoasthenoteratozoospermia
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
66
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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North Sumatra
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Medan, North Sumatra, Indonésia, 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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: PRP
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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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Sem intervenção: Non-PRP
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Blastocyst formation rate (%)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Fertilisation rate (%)
Prazo: 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 (%)
Prazo: 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 (%)
Prazo: 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 (%)
Prazo: From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
|
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 (%)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de janeiro de 2023
Conclusão Primária (Real)
30 de agosto de 2023
Conclusão do estudo (Real)
30 de dezembro de 2023
Datas de inscrição no estudo
Enviado pela primeira vez
5 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de maio de 2026
Primeira postagem (Real)
12 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de maio de 2026
Última verificação
1 de janeiro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 608.1/Dir/RSIA.SM/XII/2022
Informações sobre medicamentos e dispositivos, documentos de estudo
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