Recruiting

Exosomal miRNAs

Sponsor:

University of Central Florida

Code:

NCT07214246

Conditions

Ovarian Aging

In Vitro Fertilisation (IVF) Treatment

InVitro Fertilization

In Vitro Fertilization Outcome

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

No Interventions

Study Details

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

Study ID

NCT07214246

Start date

Sep 22, 2025

Status verified date

Oct, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

No Interventions

No interventions for participants

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Amoy Fraser, PhD, CCRP, PMP

4072668742Amoy.Fraser@ucf.edu

Britney-Ann Wray, BS, CTBS, CCRP

4072668742britney-ann.wray@ucf.edu

Locations

University of Central Florida

Recruiting

Orlando, Florida, United States, 32827

Contacts

Amoy Fraser, PhD, CCRP, PMP

4072668742Amoy.Fraser@ucf.edu

Britney-Ann Wray, BS, CCRP, CTBS

4072668742britney-ann.wray@ucf.edu

Principal Investigator:

Michal Masternak, PhD

More Information

Sponsor

University of Central Florida

Last update posted

Oct 9, 2025

Last verified

Oct, 2025

Keywords

  • IVF
  • In vitro fertilization
  • Follicular fluid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Central Florida on 2025-10-09.