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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - 50 years

Sex eligible

Female

Healthy volunteers

Not accepted

Participants

100 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Study population

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Vida Recoletas Sevilla

Study start

Dec 10, 2025 Actual

Primary completion

2028-02 Estimated

Study completion

2028-07 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.