Isolation and Characterization of the Extracellular Vesicles Secreted by the Human Endometrium

NCT02797834 | Unknown

• 1 other identifier: 1603-IGX-017-FV
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Extracellular Vesicles

Keywords

Extracellular vesicles; Endometrial fluid; Menstrual cycle; Exosomes; Microvesicles; Apoptotic bodies

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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.

  three years

Study Arms (1)

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).

Procedure: Endometrial fluid collection

Interventions

Endometrial fluid collection PROCEDURE

Patients Endometrial Fluid

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Igenomix: lead

Study Sites (1)

IVI Valencia

Valencia, Valencia, 46015, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA, RNA, proteins, lipids and other metabolits will be analyzed in the different samples of the endometrial fluid. These samples will be completely exhausted during the analysis.

Study Officials

• Felipe Vilella, BSc PhD

  Igenomix

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Gomez, BSc MSc

CONTACT

+34963905310; carlos.gomez@igenomix.com

Diana Valbuena, MD PhD

CONTACT

+34963905310; diana.valbuena@igenomix.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 14, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2019
• Last Updated: June 21, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)