Ovarian AgingNCT07214246
Follicular Fluid microRNAs in Ovarian Aging and Reproduction
An observational study of Ovarian Aging and In Vitro Fertilisation (IVF) Treatment, run by University of Central Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Aging, In Vitro Fertilisation (IVF) Treatment, InVitro Fertilization
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2025to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Central Florida
Orlando, Florida, 32827
Amoy Fraser, PhD, CCRP, PMP, 4072668742, Amoy.Fraser@ucf.edu
Britney-Ann Wray, BS, CCRP, CTBS, 4072668742, britney-ann.wray@ucf.edu
About this study
Official title: Investigating the Role of Follicular Fluid microRNAs in Ovarian Aging and Assisted Reproductive Success
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.
Read the 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.
- Conditions
- Ovarian Aging, In Vitro Fertilisation (IVF) Treatment, InVitro Fertilization, In Vitro Fertilization Outcome
- Being tested
- No Interventions
- Keywords
- IVF, In vitro fertilization, Follicular fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
No interventions for participants
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start22 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- The IVF Center at Winter Park
- Responsible party
- Sponsor
- Investigators
- Michal Masternak, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214246
- Sponsor's protocol ID
- STUDY00008057
- Status last verified
- Oct 2025
- First submitted
- 8 Oct 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of Follicular Fluid microRNAs in Ovarian Aging and Assisted Reproductive Success
- ClinicalTrials.gov ID
- NCT07214246
- Acronym / sponsor ID
- STUDY00008057
- Conditions
- Ovarian Aging, In Vitro Fertilisation (IVF) Treatment, InVitro Fertilization, In Vitro Fertilization Outcome
- Keywords
- IVF, In vitro fertilization, Follicular fluid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- The IVF Center at Winter Park
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionsNo interventions for participants | Other | – |
Primary outcome
Identify exosomal miRNAs using RNA sequencing
Time frame: 1 year
Identify differentially expressed exosomal miRNAs in the follicular fluid of younger (<31 years) versus older (>38 years) women undergoing IVF using small RNA sequencing.
Validate and assess miRNA for IVF
Time frame: 1 year
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.
Determine molecular pathways regulated by age
Time frame: 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
Related trials for Ovarian Aging
Enrolling by invitationObservational study
The Longitudinal Evaluation of Ovarian Aging and Cardiovascular Risk
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The Bone and hEArt Health Consequences of Ovarian agiNg (BEACON) Study
Ovarian Aging, Adverse Pregnancy Outcomes
RecruitingObservational study
The ROAR Study: Reactive Oxygen Species and Reproduction
Ovarian Aging, IVF Outcome
Active, not recruiting
Ovarian Function Following Intraovarian Injection of PRP
Diminished Ovarian Reserve, Diminished Ovarian Reserve Due to Advanced Maternal Age
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Effect of Rapamycin in Ovarian Aging
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michal Masternak, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Aging and In Vitro Fertilisation (IVF) Treatment, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amoy Fraser, PhD, CCRP, PMP (4072668742, Amoy.Fraser@ucf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify exosomal miRNAs using RNA sequencing (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.