Extracellular VesiclesNCT06952751
Optimization of the Isolation Protocol for Extracellular Vesicles (EVs) From Human Follicular Fluid
A study testing Differential ultracentrifugation, OptiPrep™ density gradient ultracentrifugation and Size-exclusion chromatography in people with Extracellular Vesicles, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Background: Extracellular vesicles (EVs) are membrane-bound vesicles found in all biological fluids, containing various regulatory molecules, including microRNAs (miRNAs). It has been suggested that the EVs in human follicular fluid (the fluid surrounding the oocyte within the ovary) play a crucial role in oocyte… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Extracellular Vesicles
- What is being tested?
- Differential ultracentrifugation, OptiPrep™ density gradient ultracentrifugation and Size-exclusion chromatography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Jul 2025to Dec 2029
- Phase
- Interventional
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients planned for an oocyte retrieval at Ghent University Hospital.
Who cannot join
- Diagnosis of endometriosis/adenomyosis
- Diagnosis of PCOS (Polycystic Ovary Syndrome)
- Macroscopic blood contamination at oocyte retrieval
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Eva Decroos, MD, +3293326756, eva.decroos@uzgent.be
Kathleen Wijnant, MSc, +3293323442, arg.studies@uzgent.be
About this study
Background: Extracellular vesicles (EVs) are membrane-bound vesicles found in all biological fluids, containing various regulatory molecules, including microRNAs (miRNAs). It has been suggested that the EVs in human follicular fluid (the fluid surrounding the oocyte within the ovary) play a crucial role in oocyte development through these miRNAs. However, several methods exist for isolating these EVs from follicular fluid. Before further research can be conducted on the pathophysiology and potential diagnostic and therapeutic applications of these EVs and their content, the optimal isolation technique must be determined for future studies.
Each method has its advantages and disadvantages, and the purity and efficiency may vary between species and different biological fluids. There are only a limited number of studies comparing the various techniques for application in human follicular fluid.
Read more
Objective: This study will compare the three most commonly used techniques for isolating EVs: size-based, sedimentation-based (differential ultracentrifugation), and buoyancy-based isolation techniques.
Methodology:
In this prospective study, follicular fluid will be collected from four patients undergoing transvaginal oocyte retrieval following ovarian stimulation at Ghent University Hospital. Patients over 40 years of age or with endometriosis, adenomyosis, or PCOS (polycystic ovarian syndrome) will not be included in this study. During the oocyte retrieval procedure, follicular fluid will be collected from 2-4 oocytes per patient. Since follicular fluid is not used in the patient's treatment (residual material), it does not affect the treatment.
After collection, the three isolation techniques will be applied to each sample. The techniques will be compared in terms of purity (absence of contamination) and efficiency (EV concentration) using transmission electron microscopy, nanoparticle tracking analysis, and proteomic analyses.
- Conditions
- Extracellular Vesicles
- Being tested
- Differential ultracentrifugation, OptiPrep™ density gradient ultracentrifugation, Size-exclusion chromatography, Combined techniques
- Keywords
- Extracellular vesicles, Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Differential ultracentrifugationOther
Differential ultracentrifugation
OptiPrep™ density gradient ultracentrifugationOther
OptiPrep™ density gradient ultracentrifugation
Size-exclusion chromatographyOther
Size-exclusion chromatography
Combined techniquesOther
Combined techniques
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group Receives: Other: Differential ultracentrifugation; Other: OptiPrep™ density gradient ultracentrifugation; Other: Size-exclusion chromatography; Other: Combined techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Purety
Purety of EV isolation
Measured: 3 months
Secondary outcomes (2)
Efficiency
Efficiency in terms of number of particles
Measured: 3 months
RNA efficiency
Efficiency in terms of RIN scoring
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start22 Jul 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracellular VesiclesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All collections of follicular fluid will be divided to test all three isolation methods under investigation.
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952751
- Sponsor's protocol ID
- ONZ-2024-0419
- Other IDs
- G096624N
- Status last verified
- Aug 2026
- First submitted
- 23 Apr 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Isolation Protocol for Extracellular Vesicles (EVs) From Human Follicular Fluid
- ClinicalTrials.gov ID
- NCT06952751
- Acronym / sponsor ID
- ONZ-2024-0419
- Conditions
- Extracellular Vesicles
- Keywords
- Extracellular vesicles, Isolation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 1 May 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.
Background: Extracellular vesicles (EVs) are membrane-bound vesicles found in all biological fluids, containing various regulatory molecules, including microRNAs (miRNAs). It has been suggested that the EVs in human follicular fluid (the fluid surrounding the oocyte within the ovary) play a crucial role in oocyte development through these miRNAs. However, several methods exist for isolating these EVs from follicular fluid. Before further research can be conducted on the pathophysiology and potential diagnostic and therapeutic applications of these EVs and their content, the optimal isolation technique must be determined for future studies.
Each method has its advantages and disadvantages, and the purity and efficiency may vary between species and different biological fluids. There are only a limited number of studies comparing the various techniques for application in human follicular fluid.
Objective: This study will compare the three most commonly used techniques for isolating EVs: size-based, sedimentation-based (differential ultracentrifugation), and buoyancy-based isolation techniques.
Methodology:
In this prospective study, follicular fluid will be collected from four patients undergoing transvaginal oocyte retrieval following ovarian stimulation at Ghent University Hospital. Patients over 40 years of age or with endometriosis, adenomyosis, or PCOS (polycystic ovarian syndrome) will not be included in this study. During the oocyte retrieval procedure, follicular fluid will be collected from 2-4 oocytes per patient. Since follicular fluid is not used in the patient's treatment (residual material), it does not affect the treatment.
After collection, the three isolation techniques will be applied to each sample. The techniques will be compared in terms of purity (absence of contamination) and efficiency (EV concentration) using transmission electron microscopy, nanoparticle tracking analysis, and proteomic analyses.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All collections of follicular fluid will be divided to test all three isolation methods under investigation.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Differential ultracentrifugation, Other: OptiPrep™ density gradient ultracentrifugation, Other: Size-exclusion chromatography, Other: Combined techniquesIntervention group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients planned for an oocyte retrieval at Ghent University Hospital.
Key exclusion criteria (3 listed)
- Diagnosis of endometriosis/adenomyosis
- Diagnosis of PCOS (Polycystic Ovary Syndrome)
- Macroscopic blood contamination at oocyte retrieval
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 |
|---|---|---|
| Differential ultracentrifugationDifferential ultracentrifugation | Other | Intervention group |
| OptiPrep™ density gradient ultracentrifugationOptiPrep™ density gradient ultracentrifugation | Other | Intervention group |
| Size-exclusion chromatographySize-exclusion chromatography | Other | Intervention group |
| Combined techniquesCombined techniques | Other | Intervention group |
Primary outcome
Purety
Time frame: 3 months
Purety of EV isolation
2 secondary outcomes
Efficiency
Time frame: 3 months
RNA efficiency
Time frame: 6 months
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 1 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Differential ultracentrifugation, OptiPrep™ density gradient ultracentrifugation and Size-exclusion chromatography in people with Extracellular Vesicles, run by University Hospital, Ghent at 1 site in Belgium.
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 1 inclusion and 3 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 1 Sep 2026. 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 Belgium. 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 Dominic Stoop, Prof. dr. (+ 329 332 34 42, arg.studies@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Purety (time frame: 3 months). 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 1 Sep 2026.