Differential Granulosa Cell Transcriptome Profiling as a Predictive Tool of Ongoing Pregnancy

De qué trata este estudio

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Tipo de estudio

Observacional

Fase

No aplica / no indicada

Rango de edad

18 años - 50 años

Sexo admitido

Femenino

Voluntarios sanos

No aceptados

Participantes

100 Estimado

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Acerca de la investigación

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.

¿Quién podría participar?

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INCLUSION CRITERIA:

• 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
• 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
• 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

Población del estudio

Women from 18 to 50 years of age attending VIDA Sevilla clinic for oocyte donation or reproductive treatment

Tratamiento, grupos y participación

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Asignación

No informado

Enmascaramiento

No informado

Qué evalúan los investigadores

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Medidas principales

Centros de investigación (1)

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1 centros

Equipo y fechas

Patrocinador principal

Vida Recoletas Sevilla

Inicio del estudio

10 dic 2025 Real

Finalización primaria

2028-02 Estimado

Finalización del estudio

2028-07 Estimado

Primera publicación

10 nov 2026 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.