NCT06952751 Optimization of the Isolation Protocol for Extracellular Vesicles (EVs) From Human Follicular Fluid
| NCT ID | NCT06952751 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Extracellular Vesicles |
| Study Type | INTERVENTIONAL |
| Enrollment | 4 participants |
| Start Date | 2025-07-22 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4 participants in total. It began in 2025-07-22 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * Patients planned for an oocyte retrieval at Ghent University Hospital. Exclusion Criteria: * Diagnosis of endometriosis/adenomyosis * Diagnosis of PCOS (Polycystic Ovary Syndrome) * Macroscopic blood contamination at oocyte retrieval
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06952751 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Extracellular Vesicles. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06952751 currently recruiting?
Yes, NCT06952751 is actively recruiting participants. Contact the research team at arg.studies@uzgent.be for enrollment information.
Where is the NCT06952751 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT06952751 clinical trial?
NCT06952751 is sponsored by University Hospital, Ghent. The trial plans to enroll 4 participants.