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

November 4, 2026 updated by: Vida Recoletas Sevilla

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: OTHER
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
AMA

Female IVF patients aged 40 or older, undergoing ICSI + PGT-A treatment with own oocytes
FOD

Fresh oocyte donation cycle patients (donor and recipient)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify predicitve biomarkers for ongoing pregnancy
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vida Recoletas Sevilla

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

November 4, 2026

First Submitted That Met QC Criteria

November 4, 2026

First Posted (Actual)

November 10, 2026

Study Record Updates

Last Update Posted (Actual)

November 10, 2026

Last Update Submitted That Met QC Criteria

November 4, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2209-SEV-126-MF
  • 25/1188 (Other Grant/Funding Number: Corporación Tecnológica de Andalucía)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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