- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07929779
Differential Granulosa Cell Transcriptome Profiling as a Predictive Tool of Ongoing Pregnancy (GRANULOMIC)
Fertility problems are increasingly common in industrialized countries. It is estimated that 15-20% of couples of reproductive age have problems conceiving children naturally and the use of assisted reproductive treatment accounts for 1-3% of annual births. Among the causes of infertility, the female factor is responsible for approximately 40% of cases. The growing problem of infertility and the decline in the birth rate in Spain make absolutely necessary the improvement of assisted reproductive technology (ART). Actually, one of the main problems of ART is the election of the oocyte, as there is no method to select the best embryos for subsequent transfer. The average number of oocytes obtained from one woman in each cycle is 10-11, so the finding of a (some) biomarker(s) would have a great impact at a social and economic level and would commensurately reduce the economic cost of each cycle. Novel embryo assessment strategies are currently being developed and can be used alone or in combination with morphologic criteria. These include non-invasive methodologies as artificial intelligence using morphokinetic databases and the OMICS, like transcriptomic, proteomic and metabolomic. Among others, the transcriptome of the cumulus cells is a potentially valuable non-invasive biomarker. Indeed, it is already known that granulosa cells play a crucial role in the regulation of female fertility. The bi-directional communication between the oocyte and the surrounding cumulus cells is essential for the maturation of a developmentally competent oocyte, ovulation and fertilization, processes which are necessary for initiating and sustaining embryo development. Our work hypothesis is that the cumulus cell transcriptome would be directly related and give an essential information about oocyte maturation and fertilization ability.
Unfortunately, even though several studies on granulosa cell transcriptome analysis have been performed, the obtained data are still inconclusive. The main reason for this should be found in the study design which, in most cases, are performed in a small number of patients and presented a heterogeneous population.
Among others, there are great variations in the patients' age and physical characteristics, type of treatment, diagnosis, hormonal levels and endometrial receptivity. The main objective of this project is to find new unknown biomarker(s) of ongoing pregnancy by analyzing the whole transcriptome of the two granulosa cell layers surrounding the oocytes (cumulus cells and corona radiata). Specifically, the study aims to find a biomarker of oocyte maturity, of fertilization, of embryo quality, of euploid embryos, of pregnancy, early miscarriage or ongoing pregnancy, and finally, to find a correlation between these biomarkers and the morphokinetic of the embryos. An additional advantage of our project is the use of material that is obtained at the time of transvaginal ultrasound-guided oocyte retrieval but that is considered a waste and is usually discarded in Assisted Reproduction Centers. Therefore, the analysis of these cells does not suppose any change or bother for the women, in relation to the treatments of assisted reproduction.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Sevilla
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Seville, Sevilla, Espanha, 41092
- Recrutamento
- Vida Recoletas Sevilla
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Contato:
- Clara Palacio de Marco, MSc
- Número de telefone: 56661 0034954286274
- E-mail: vida.investiga@gruporecoletas.com
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Contato:
- Esther Santamaría López, MSc
- Número de telefone: 56739 0034954286274
- E-mail: vida.investiga@gruporecoletas.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Women from 18 to 50 years of age attending VIDA Sevilla clinic for oocyte donation or reproductive treatment
Descrição
INCLUSION CRITERIA:
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Advanced maternal age patients:
- Between 40 and 45 years old, both inclusive
- Patient at VIDA Sevilla
- IVF cycle with own oocytes (fresh)
- PGT-A cycle
- Consent to perform embryo culture in Embryoscope
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Oocyte donors:
- Between 18 and 35 years old
- Being an oocyte donor accepted by VIDA Sevilla according to standard donor selection criteria at this clinic
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Oocyte recipients:
- Patient at VIDA Sevilla
- Younger than 51 years old
- IVF cycle with fresh donor oocytes
- Consent to perform embryo culture in Embryoscope
- Matched donor already included in the study
EXCLUSION CRITERIA:
- Abnormal karyotype
- Reproductive tract anomalies
- Radio and chemotherapy treatments
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: OTHER
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
|---|
|
AMA
Female IVF patients aged 40 or older, undergoing ICSI + PGT-A treatment with own oocytes |
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FOD
Fresh oocyte donation cycle patients (donor and recipient) |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Identify predicitve biomarkers for ongoing pregnancy
Prazo: From enrollment to the end of follow-up at 8 weeks of gestational age.
|
Ongoing pregnancy is defined by the detection of a fetal heartbeat in a pregnancy. |
From enrollment to the end of follow-up at 8 weeks of gestational age.
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2209-SEV-126-MF
- 25/1188 (Número de outro subsídio/financiamento: Corporación Tecnológica de Andalucía)
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