Extracellular VesiclesNCT02797834
Isolation and Characterization of the Extracellular Vesicles Secreted by the Human Endometrium
An observational study of Extracellular Vesicles, run by Igenomix at 1 site in Spain.
Trial summary
The main aim of this study is to describe the morphology, size distributions and specific markers of the different vesicles populations present in the human endometrial fluid. To further characterize the vesicles populations, contents of these membrane compartments (i.e.: DNA, RNA, proteins, lipids and other small… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Extracellular Vesicles
- What is being tested?
- Endometrial fluid collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Analysis in this study will be done using endometrial fluid samples retrieved from healthy, fertile, normal-cycling women which meet the inclusion/exclusion criteria. These patients will be recruited in a single national centre: IVI Valencia. Their recruitment will be done during the routine clinical practice by the research group in the previously mentioned centre. The research group will be in charge of checking patients' medical reports and getting in contact with those patients that meet the selection criteria and are willing to participate in the study.
Who may be able to join
- Healthy women in natural cycles.
- Age: 18 to 35 years (both included).
- Normal karyotype.
- Negative serological results for HIV, HBV, HBC, RPR.
- BMI: 18-30 Kg/m2 (both included).
- Regular menstrual cycle (3-4/28-30 days).
Who cannot join
- Patients who had carried a IUD device in the previous 3 months.
- Patients who had taken hormonal contraceptives in the previous 2 months.
- Adnexal or uterine pathologies.
- Polycystic ovary syndrome.
- Patients suffering from serious or uncontrolled bacterial, fungal or viral infectious diseases that could potentially interfere with the participation of the patient or with the results of the study (evaluated by the principal researcher of the research team).
- Any unstable disease or medical condition that could interfere with the study or put in risk the health of the patient (evaluated by the principal researcher of the research team).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
IVI Valencia
Valencia, Valencia, 46015
Carlos Simon, MD PhD, +34963050900, carlos.simon@ivi.es
About this study
Official title: Isolation and Characterization of the Extracellular Vesicles Secreted by the Human Endometrium to the Endometrial Fluid
The main aim of this study is to describe the morphology, size distributions and specific markers of the different vesicles populations present in the human endometrial fluid. To further characterize the vesicles populations, contents of these membrane compartments (i.e.: DNA, RNA, proteins, lipids and other small metabolites) will be assessed by using mass spectrometry and next generation sequencing techniques. The objective here is to relate a specific vesicles composition to the moment of the cycle, to a normal physiological endometrial function and to the transmission of functionalities from the mother to the embryo.
Read the detailed description
In the last decades, the emission of membrane enclosed compartments, more commonly regarded as extracellular vesicles, has been established as a new mechanism of communication either between cells of a complex organism, between unicellular organisms or between unicellular organism and host. These vesicles have been described in all body fluids and are currently classified into three types according to the mechanism by which they are formed: exosomes, with sizes ranging from 30 to 150 nm (formed intracellularly); microvesicles, between 100 and 1000 nm (formed from the cell membrane) and apoptotic bodies, with sizes greater than 1 µm (produced by cells undergoing programmed cell death).
Endometrial fluid is a viscous liquid present in the uterine cavity originating from the different cell types that form the uterus and serum exudates. It offers a precise view of the context in which the embryo implants and can be retrieved by a minimally invasive technique.
The main objective of this pilot study is to isolate and characterize the extracellular vesicles secreted by the endometrium to the endometrial fluid, being this the first time that this fact is being described. It is intended to standardize a method for the isolation of the different vesicles populations present within the endometrial fluid (i.e.: apoptotic bodies, microvesicles and exosomes), based on serial differential centrifugations and filtration. Morphological characterization of the isolated vesicles will be done at three levels: study of the external morphology by transmission electron microscopy, characterization of the different vesicles populations surface markers by Western Blot and analysis of the vesicles populations size distributions by Nanoparticle Tracking Analysis.
The second part of the study is directed to assess the content of the extracellular vesicles throughout the menstrual cycle. For this purpose, a canonical menstrual cycle of 28 to 30 days has been classified in 5 phases: phase I (days 0-8), phase II (days 9-14), phase III (days 15-18), phase IV (days 19-24) and phase V (25 to 30). The experimental design for vesicles contents description consists of two levels of comparison: (1) analysis of differential contents of the different populations of vesicles in the same phase of the menstrual cycle and for each of the phases and (2) analysis of differential contents of the same population of vesicles in each phase of the cycle and for each of the vesicular populations. This characterization of the vesicular contents will be made using mass spectrometry techniques to analyze the protein, lipid and other small metabolites composition. Their presence aims to be related both to the moment of the cycle and to a normal physiological function of the endometrium. On the other hand, analysis of DNA and RNA contents of these vesicular populations by massive sequencing will be performed. The objective here is to analyze the transmission of functionalities to target cells as well as the potential predictive usefulness of these molecules to determine the moment of the menstrual cycle.
- Conditions
- Extracellular Vesicles
- Being tested
- Endometrial fluid collection
- Keywords
- Extracellular vesicles, Endometrial fluid, Menstrual cycle, Exosomes, Microvesicles, Apoptotic bodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial fluid collectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients Endometrial Fluid | Endometrial fluid samples from healthy and fertile women in their natural cycles, with ages ranging from 18 to 35 years, normal karyotype, negative for HIV, HBV, HCV and RPR, BMI ranging from 18 to 30 Kg/m2 (both included) and regular menstrual cycle (3-4/28-30 days).
This unique assignment group will be divided into 5 subgroups attending to the moment of the menstrual cycle in which the patient could be classified: phase I (days 0-8), phase II (days 9-14), phase III (days 15-18), phase IV (days 19-24) and phase V (days 25-30). Receives: Procedure: Endometrial fluid collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphological characterization of the extracellular vesicles
Assessment of the morphology of the extracellular vesicles using transmision electron microscopy by either ultrathin cuts and positive staining or deposition and positive staining techniques.
The aim is to differentiate between vesicle populations thanks to their external aspects and size.
Measured: 3 months
Size distribution profiles characterization of the extracellular vesicles
Analysis of the size distribution of the vesicles contained in the different extracellular vesicles populations by using two Nanoparticle Tracking Analysis techniques: ZetaSizer Nano and NanoSight300.
The expected outcome is a set of graphs with size range data of the vesicles in the different populations and vesicle concentration data when using NanoSight300.
Measured: 45 days
Characterization of extracellular vesicles populations by specific markers
Analysis of population-specific markers by Western Blot in order to further differentiate endometrial fluid vesicles populations.
The aim is to differentiate populations based on the presence or absence of these markers.
Measured: 45 days
Secondary outcomes (1)
Qualitative (names) and quantitative (expression levels) information about the different biomolecules that could be present in the samples: DNA, RNA, proteins, lipids and other small metabolites.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2019 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Igenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Felip Vilella, Igenomix
- Investigators
- Felipe Vilella, BSc PhD, Principal investigator, Igenomix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797834
- Sponsor's protocol ID
- 1603-IGX-017-FV
- Status last verified
- Jun 2016
- First submitted
- 2 Jun 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolation and Characterization of the Extracellular Vesicles Secreted by the Human Endometrium to the Endometrial Fluid
- ClinicalTrials.gov ID
- NCT02797834
- Acronym / sponsor ID
- 1603-IGX-017-FV
- Conditions
- Extracellular Vesicles
- Keywords
- Extracellular vesicles, Endometrial fluid, Menstrual cycle, Exosomes, Microvesicles, Apoptotic bodies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IgenomixIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 14 Jun 2016 (estimated)
- 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 main aim of this study is to describe the morphology, size distributions and specific markers of the different vesicles populations present in the human endometrial fluid. To further characterize the vesicles populations, contents of these membrane compartments (i.e.: DNA, RNA, proteins, lipids and other small metabolites) will be assessed by using mass spectrometry and next generation sequencing techniques. The objective here is to relate a specific vesicles composition to the moment of the cycle, to a normal physiological endometrial function and to the transmission of functionalities from the mother to the embryo.
Detailed description
In the last decades, the emission of membrane enclosed compartments, more commonly regarded as extracellular vesicles, has been established as a new mechanism of communication either between cells of a complex organism, between unicellular organisms or between unicellular organism and host. These vesicles have been described in all body fluids and are currently classified into three types according to the mechanism by which they are formed: exosomes, with sizes ranging from 30 to 150 nm (formed intracellularly); microvesicles, between 100 and 1000 nm (formed from the cell membrane) and apoptotic bodies, with sizes greater than 1 µm (produced by cells undergoing programmed cell death).
Endometrial fluid is a viscous liquid present in the uterine cavity originating from the different cell types that form the uterus and serum exudates. It offers a precise view of the context in which the embryo implants and can be retrieved by a minimally invasive technique.
The main objective of this pilot study is to isolate and characterize the extracellular vesicles secreted by the endometrium to the endometrial fluid, being this the first time that this fact is being described. It is intended to standardize a method for the isolation of the different vesicles populations present within the endometrial fluid (i.e.: apoptotic bodies, microvesicles and exosomes), based on serial differential centrifugations and filtration. Morphological characterization of the isolated vesicles will be done at three levels: study of the external morphology by transmission electron microscopy, characterization of the different vesicles populations surface markers by Western Blot and analysis of the vesicles populations size distributions by Nanoparticle Tracking Analysis.
The second part of the study is directed to assess the content of the extracellular vesicles throughout the menstrual cycle. For this purpose, a canonical menstrual cycle of 28 to 30 days has been classified in 5 phases: phase I (days 0-8), phase II (days 9-14), phase III (days 15-18), phase IV (days 19-24) and phase V (25 to 30). The experimental design for vesicles contents description consists of two levels of comparison: (1) analysis of differential contents of the different populations of vesicles in the same phase of the menstrual cycle and for each of the phases and (2) analysis of differential contents of the same population of vesicles in each phase of the cycle and for each of the vesicular populations. This characterization of the vesicular contents will be made using mass spectrometry techniques to analyze the protein, lipid and other small metabolites composition. Their presence aims to be related both to the moment of the cycle and to a normal physiological function of the endometrium. On the other hand, analysis of DNA and RNA contents of these vesicular populations by massive sequencing will be performed. The objective here is to analyze the transmission of functionalities to target cells as well as the potential predictive usefulness of these molecules to determine the moment of the menstrual cycle.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Endometrial Fluid | – | Procedure: Endometrial fluid collectionEndometrial fluid samples from healthy and fertile women in their natural cycles, with ages ranging from 18 to 35 years, normal karyotype, negative for HIV, HBV, HCV and RPR, BMI ranging from 18 to 30 Kg/m2 (both included) and regular menstrual cycle (3-4/28-30 days). This unique assignment group will be divided into 5 subgroups attending to the moment of the menstrual cycle in which the patient could be classified: phase I (days 0-8), phase II (days 9-14), phase III (days 15-18), phase IV (days 19-24) and phase V (days 25-30). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Analysis in this study will be done using endometrial fluid samples retrieved from healthy, fertile, normal-cycling women which meet the inclusion/exclusion criteria. These patients will be recruited in a single national centre: IVI Valencia. Their recruitment will be done during the routine clinical practice by the research group in the previously mentioned centre. The research group will be in charge of checking patients' medical reports and getting in contact with those patients that meet the selection criteria and are willing to participate in the study.
Key inclusion criteria (6 listed)
- Healthy women in natural cycles.
- Age: 18 to 35 years (both included).
- Normal karyotype.
- Negative serological results for HIV, HBV, HBC, RPR.
- BMI: 18-30 Kg/m2 (both included).
Key exclusion criteria (6 listed)
- Patients who had carried a IUD device in the previous 3 months.
- Patients who had taken hormonal contraceptives in the previous 2 months.
- Adnexal or uterine pathologies.
- Polycystic ovary syndrome.
- Patients suffering from serious or uncontrolled bacterial, fungal or viral infectious diseases that could potentially interfere with the participation of the patient or with the results of the study (evaluated by the principal researcher of the research team).
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 |
|---|---|---|
| Endometrial fluid collection | Procedure or surgery | Patients Endometrial Fluid |
Primary outcome
Morphological characterization of the extracellular vesicles
Time frame: 3 months
Assessment of the morphology of the extracellular vesicles using transmision electron microscopy by either ultrathin cuts and positive staining or deposition and positive staining techniques. The aim is to differentiate between vesicle populations thanks to their external aspects and size.
Size distribution profiles characterization of the extracellular vesicles
Time frame: 45 days
Analysis of the size distribution of the vesicles contained in the different extracellular vesicles populations by using two Nanoparticle Tracking Analysis techniques: ZetaSizer Nano and NanoSight300. The expected outcome is a set of graphs with size range data of the vesicles in the different populations and vesicle concentration data when using NanoSight300.
Characterization of extracellular vesicles populations by specific markers
Time frame: 45 days
Analysis of population-specific markers by Western Blot in order to further differentiate endometrial fluid vesicles populations. The aim is to differentiate populations based on the presence or absence of these markers.
1 secondary outcome
Qualitative (names) and quantitative (expression levels) information about the different biomolecules that could be present in the samples: DNA, RNA, proteins, lipids and other small metabolites.
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- 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. This study is not recruiting at the moment.
Felipe Vilella, BSc PhD principal investigator
Igenomix
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 Extracellular Vesicles, run by Igenomix at 1 site in Spain.
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 6 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: status not confirmed, as of the sponsor's last update on 21 Jun 2016. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Gomez, BSc MSc (+34963905310, carlos.gomez@igenomix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphological characterization of the extracellular vesicles (time frame: 3 months). 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 21 Jun 2016.