Follicular Fluid microRNAs in Ovarian Aging and Reproduction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Interventions.
- Who it may be relevant to
- Registry conditions: Ovarian Aging, In Vitro Fertilisation (IVF) Treatment, InVitro Fertilization, In Vitro Fertilization Outcome. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigating the Role of Follicular Fluid microRNAs in Ovarian Aging and Assisted Reproductive Success
Overview
The purpose of this study is to investigate the role of exosomal microRNAs (miRNAs) in follicular fluid (FF) as biomarkers of ovarian aging and predictors of in vitro fertilization (IVF) outcomes. The goal is to identify noninvasive molecular markers that correlate with oocyte quality and reproductive potential, particularly in women of advanced maternal age.
Detailed description
There is a substantial gap in understanding how these miRNAs operate in humans, especially in a non-invasive or minimally invasive context.
Specifically:
* The role of exosomal miRNAs in follicular fluid (FF) in human ovarian aging is not well defined. * Few studies have directly compared miRNA expression profiles in FF across age groups using high-throughput sequencing. * There is limited evidence linking specific FF miRNAs to oocyte quality or IVF success rates. * No validated non-invasive biomarkers based on FF exosomal miRNA currently exist for predicting IVF outcomes, especially in women of advanced reproductive age.
This study seeks to address these knowledge gaps by identifying and validating exosomal miRNA signatures in FF that are associated with maternal age and IVF outcomes. The most relevant preliminary data come from preclinical rodent studies performed by our research team:
* miRNA profiling in aged vs. young mouse ovarian tissues demonstrated clear age-associated changes in miRNA expression. * Gene target analyses revealed that these miRNAs are likely to regulate critical signaling pathways involved in ovarian aging (e.g., FoxO, mTOR, PI3k/Akt). * These results support the biological plausibility that similar miRNA changes could occur in human follicular environments and impact oocyte competence.
Although direct human data from FF is not yet available, the team has validated methods for exosome isolation from biofluids, miRNA sequencing, and in vitro assays. These tools are now being applied to the human FF samples collected during IVF cycles, making this study a logical and feasible extension of our previous work.
Interventions
- Other No Interventions
No interventions for participants
Primary outcome measures
- Identify exosomal miRNAs using RNA sequencing [Time frame: 1 year]
- Validate and assess miRNA for IVF [Time frame: 1 year]
- Determine molecular pathways regulated by age [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Women undergoing IVF treatment due to male factor infertility or nonovarian causes.
- Age groups: younger women <31 years and older women >38 years.
- Regular menstrual cycles.
- Willing and able to provide informed consent.
Exclusion criteria
- Minors (under 18 years) and women aged 32-37 years
- Diagnosis of polycystic ovarian syndrome (PCOS).
- History of recurrent pregnancy loss.
- Presence of endometriosis.
- Diagnosis of ovarian insufficiency.
- Metabolic disorders (e.g., diabetes).
- History of ovarian surgery or chemotherapy.
- Any condition that might impact follicular fluid quality or IVF outcomes.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- University of Central Florida — Orlando
Identifiers
NCT: NCT07214246 · STUDY00008057