Follicular Fluid microRNAs in Ovarian Aging and Reproduction

NCT07214246 | Recruiting

• 1 other identifier: STUDY00008057
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Aging; In Vitro Fertilisation (IVF) Treatment; InVitro Fertilization; In Vitro Fertilization Outcome

Keywords

IVF; In vitro fertilization; Follicular fluid

Outcome Measures

Primary Outcomes (3)

• Identify exosomal miRNAs using RNA sequencing

  Identify differentially expressed exosomal miRNAs in the follicular fluid of younger (\<31 years) versus older (\>38 years) women undergoing IVF using small RNA sequencing.

  1 year

• Validate and assess miRNA for IVF

  Validate the expression of selected miRNAs in an independent sample set and assess their correlation with clinical IVF parameters, including oocyte maturity, fertilization, and embryo development.

  1 year

• Determine molecular pathways regulated by age

  Use bioinformatic analysis and in vitro functional assays to determine the molecular pathways regulated by age associated miRNAs, particularly those involved in follicular development, hormone signaling, and cellular aging.

  1 year

Interventions

No Interventions OTHER

No interventions for participants

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women undergoing IVF treatments.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be screened and identified during their initial consultation and scheduling for IVF treatment at The IVF Center. Medical records and patient history will be reviewed to screen for eligibility based on inclusion and exclusion criteria. Women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate and consented for the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Central Florida: lead
• The IVF Center at Winter Park: collaborator

Study Sites (1)

University of Central Florida

Orlando, Florida, 32827, United States

RECRUITING

Study Officials

• Michal Masternak, PhD

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amoy Fraser, PhD, CCRP, PMP

CONTACT

4072668742; Amoy.Fraser@ucf.edu

Britney-Ann Wray, BS, CTBS, CCRP

CONTACT

4072668742; britney-ann.wray@ucf.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 9, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

US (1)