Extracellular VesiclesNCT07148284
Characterization of EVs (Extracellular Vesicles)/miRNAs (microRNAs) From Human Follicular Fluid
A study testing Isolation of EVs + RNA sequencing 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. They contain various regulatory molecules, including microRNAs (miRNAs). It is hypothesized that 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 45 years, women only
- Conditions the study is for
- Extracellular Vesicles
- What is being tested?
- Isolation of EVs + RNA sequencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2025to Dec 2025
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent.
- Oocyte retrieval planned for an coPGT-M ICSI trajectory at Ghent University Hospital.
- BMI 18,5-30 kg/m2.
- Normal karyotype of patient and partner.
- Ovarian stimulation protocol: PPOS (progestin-primed ovarian stimulation) with recombinant gonadotropins and GnRH agonist trigger.
- A minimum of 5 growing follicles during ovarian stimulation.
Who cannot join
- Diagnosis of endometriosis
- Diagnosis of PCOS according to Rotterdam criteria
- Poor ovarian responders according to Bologna criteria
- Severe male subfertility: semen concentration < 5 million/ml or TESE
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
Ghent University Hospital
Ghent, 9000
Eva Decroos, Dr., +3293323442, arg.studies@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. They contain various regulatory molecules, including microRNAs (miRNAs). It is hypothesized that EVs in human follicular fluid (the fluid surrounding the oocyte within the ovary) play a crucial role in oocyte development through these miRNAs.
- Research Question Is there a difference in miRNA expression in EVs in human follicular fluid based on the patient's age, the maturation stage of the corresponding oocyte, and/or the ploidy status of the resulting embryo (euploid in the case of a normal chromosome count vs. aneuploid in the case of an abnormal chromosome count)?
- Methodology This prospective study will include patients in two age groups (≥ 38 years vs. ≤ 32 years; 7 patients per group) undergoing an ICSI treatment (intracytoplasmic sperm injection) in combination with a coPGT-M treatment at Ghent University Hospital. PGT-M (pre-implantation genetic testing for monogenic disorders) is an IVF/ICSI procedure in which an embryo biopsy is performed on day 5 or 6 of embryo development to test for known genetic disorders that could be inherited from one or both parents. With the coPGT-M technology or comprehensive PGT-M, in addition to detecting known genetic defects, any additional chromosomal abnormalities in the embryo are also identified. An embryo is considered aneuploid if its chromosome number is abnormal.
For the participating patients, follicular fluid and plasma will be collected, and consent will be requested to store non-developing oocytes and embryos from the ICSI treatment.
Read more
Inclusion will take place on day 10 of ovarian stimulation if the patient meets the inclusion and exclusion criteria and at least 5 follicles are confirmed to be growing.
- Follicular Fluid (residual material): After oocyte retrieval, follicular fluid will be collected from 2-10 follicles per patient. EV isolation from this follicular fluid will be performed using the optimal technique determined in a preceding experiment (ID 18220, see 'Relations', comparison of 3 existing techniques to determine the optimal EV isolation technique from human follicular fluid). RNA extraction followed by miRNA sequencing will be used to assess differences in miRNA expression based on age (≤ 32 years vs. ≥ 38 years), oocyte maturation stage (mature vs. immature), and the ploidy status of the resulting embryo (euploid vs. aneuploid). In addition, the following hormone concentrations will be determined in the follicular fluid: estradiol, progesterone, follicle-stimulating hormone (FSH), and luteinizing hormone (LH).
- Plasma: For participating patients, an additional blood tube will be taken during each blood sample/infusion placement within the standard-of-care IVF/ICSI treatment from day 10 of ovarian stimulation until the day of oocyte retrieval. EV isolation and RNA extraction will be performed on plasma samples of the ovulation trigger day and oocyte retrieval day. MiRNA sequencing of these samples will be correlated with the miRNA expression of EVs in follicular fluid.
- Conditions
- Extracellular Vesicles
- Being tested
- Isolation of EVs + RNA sequencing
- Keywords
- Extracellular vesicles, RNA sequencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolation of EVs + RNA sequencingOther
Isolation of EVs + RNA sequencing
| Study group | Role | What they receive |
|---|---|---|
| ≤ 32 years | Active comparator | Not described Receives: Other: Isolation of EVs + RNA sequencing |
| ≥ 38 years | Active comparator | Not described Receives: Other: Isolation of EVs + RNA sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential miRNA expression based on the ploidy status of the resulting embryo
Measured: 6 months
Secondary outcomes (2)
Differential miRNA expression based on the patient's age
Measured: 6 months
Differential miRNA expression based on the maturation stage of the corresponding oocyte
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 posted29 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (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.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148284
- Sponsor's protocol ID
- ONZ-2024-0499
- Other IDs
- G096624N
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 29 Aug 2025
- 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 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of EVs (Extracellular Vesicles)/miRNAs (microRNAs) From Human Follicular Fluid
- ClinicalTrials.gov ID
- NCT07148284
- Acronym / sponsor ID
- ONZ-2024-0499
- Conditions
- Extracellular Vesicles
- Keywords
- Extracellular vesicles, RNA sequencing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Aug 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. They contain various regulatory molecules, including microRNAs (miRNAs). It is hypothesized that EVs in human follicular fluid (the fluid surrounding the oocyte within the ovary) play a crucial role in oocyte development through these miRNAs.
- Research Question Is there a difference in miRNA expression in EVs in human follicular fluid based on the patient's age, the maturation stage of the corresponding oocyte, and/or the ploidy status of the resulting embryo (euploid in the case of a normal chromosome count vs. aneuploid in the case of an abnormal chromosome count)?
- Methodology This prospective study will include patients in two age groups (≥ 38 years vs. ≤ 32 years; 7 patients per group) undergoing an ICSI treatment (intracytoplasmic sperm injection) in combination with a coPGT-M treatment at Ghent University Hospital. PGT-M (pre-implantation genetic testing for monogenic disorders) is an IVF/ICSI procedure in which an embryo biopsy is performed on day 5 or 6 of embryo development to test for known genetic disorders that could be inherited from one or both parents. With the coPGT-M technology or comprehensive PGT-M, in addition to detecting known genetic defects, any additional chromosomal abnormalities in the embryo are also identified. An embryo is considered aneuploid if its chromosome number is abnormal.
For the participating patients, follicular fluid and plasma will be collected, and consent will be requested to store non-developing oocytes and embryos from the ICSI treatment.
Inclusion will take place on day 10 of ovarian stimulation if the patient meets the inclusion and exclusion criteria and at least 5 follicles are confirmed to be growing.
- Follicular Fluid (residual material): After oocyte retrieval, follicular fluid will be collected from 2-10 follicles per patient. EV isolation from this follicular fluid will be performed using the optimal technique determined in a preceding experiment (ID 18220, see 'Relations', comparison of 3 existing techniques to determine the optimal EV isolation technique from human follicular fluid). RNA extraction followed by miRNA sequencing will be used to assess differences in miRNA expression based on age (≤ 32 years vs. ≥ 38 years), oocyte maturation stage (mature vs. immature), and the ploidy status of the resulting embryo (euploid vs. aneuploid). In addition, the following hormone concentrations will be determined in the follicular fluid: estradiol, progesterone, follicle-stimulating hormone (FSH), and luteinizing hormone (LH).
- Plasma: For participating patients, an additional blood tube will be taken during each blood sample/infusion placement within the standard-of-care IVF/ICSI treatment from day 10 of ovarian stimulation until the day of oocyte retrieval. EV isolation and RNA extraction will be performed on plasma samples of the ovulation trigger day and oocyte retrieval day. MiRNA sequencing of these samples will be correlated with the miRNA expression of EVs in follicular fluid.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ≤ 32 years | Active comparator | Other: Isolation of EVs + RNA sequencing |
| ≥ 38 years | Active comparator | Other: Isolation of EVs + RNA sequencing |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed informed consent.
- Oocyte retrieval planned for an coPGT-M ICSI trajectory at Ghent University Hospital.
- BMI 18,5-30 kg/m2.
- Normal karyotype of patient and partner.
- Ovarian stimulation protocol: PPOS (progestin-primed ovarian stimulation) with recombinant gonadotropins and GnRH agonist trigger.
Key exclusion criteria (4 listed)
- Diagnosis of endometriosis
- Diagnosis of PCOS according to Rotterdam criteria
- Poor ovarian responders according to Bologna criteria
- Severe male subfertility: semen concentration < 5 million/ml or TESE
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 |
|---|---|---|
| Isolation of EVs + RNA sequencingIsolation of EVs + RNA sequencing | Other | ≤ 32 years, ≥ 38 years |
Primary outcome
Differential miRNA expression based on the ploidy status of the resulting embryo
Time frame: 6 months
2 secondary outcomes
Differential miRNA expression based on the patient's age
Time frame: 6 months
Differential miRNA expression based on the maturation stage of the corresponding oocyte
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 29 Aug 2025.
- 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 Isolation of EVs + RNA sequencing 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 29 Aug 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 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?
Differential miRNA expression based on the ploidy status of the resulting embryo (time frame: 6 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 29 Aug 2025.