Follicular fluid microRNAs and ovarian aging linked to IVF outcomes
Investigating the Role of Follicular Fluid microRNAs in Ovarian Aging and Assisted Reproductive Success
This project will test whether tiny RNA molecules (exosomal microRNAs) in the fluid around eggs can indicate egg quality and predict IVF success for women under 31 or over 38 undergoing IVF.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Central Florida Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT07214246 on ClinicalTrials.gov |
What this trial studies
This is an observational study that will collect follicular fluid during IVF cycles and isolate exosomal microRNAs for high-throughput sequencing. Researchers will compare miRNA expression profiles between younger (<31) and older (>38) women and correlate identified signatures with oocyte quality and IVF outcomes. Validated exosome isolation and sequencing methods will be used, followed by gene-target and pathway analyses to interpret biological relevance. Findings will be compared with existing preclinical data and may be validated in additional samples.
Who should consider this trial
Good fit: Women undergoing IVF for male-factor or other nonovarian reasons who are younger than 31 or older than 38, have regular menstrual cycles, and can provide informed consent are ideal candidates.
Not a fit: Women aged 32–37 and those with PCOS, endometriosis, ovarian insufficiency, metabolic disorders, prior ovarian surgery or chemotherapy, or other conditions affecting follicular fluid are excluded and unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this could enable a noninvasive molecular test using follicular fluid miRNA patterns to better predict which eggs are most likely to lead to a successful IVF pregnancy, especially for older women.
How similar studies have performed: Direct human studies of follicular fluid exosomal miRNAs are limited, though the investigators' rodent studies show clear age-associated miRNA changes that support biological plausibility.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Orlando, Florida
- University of Central Florida — Orlando, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Michal Masternak, PhD — University of Central Florida
- Study coordinator: Amoy Fraser, PhD, CCRP, PMP
- Email: Amoy.Fraser@ucf.edu
- Phone: 4072668742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.