Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06356753 |
| Other study ID # |
RC19_0203 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2019 |
| Est. completion date |
March 31, 2021 |
Study information
| Verified date |
April 2024 |
| Source |
Nantes University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
For several years, the effects of environmental pollution on human health have been a growing
concern for the scientific community and public authorities. Among the many known chemical
contaminants, persistent organic pollutants (POPs) are of particular concern because of their
properties as endocrine disrupters, bioaccumulation and biomagnification. The associations
between environmental pollutants, endometriosis and infertility remains poorly understood.
The objective of this exploratory non interventional monocentric study conducted in the
University Hospital of Nantes, is to identify endogenous molecular profiles associated with
endometriosis and related infertility. This project implements an exploratory approach
combining exposure and metabolomics approaches based on high-resolution mass spectrometry to
identify exposure and metabolomics profiles associated with infertility, and biomarkers for
potential prognostic application.
Description:
LABERCA, a national reference laboratory for chemical pollutants and a labelled metabolomics
platform, has developed a new integrative exposure-metabolomics approach based on
high-resolution mass spectrometry technologies allowing the exploration of endogenous and
exogenous chemical space within biological matrices, coupled with advanced biostatistical
methods to promote the identification of biomarkers in health studies (Cano-Sancho et al.,
2019). This approach is of great interest both for fundamental research of an etiological and
mechanistic nature on complex multifactorial diseases, but also for translational research,
which accelerates the application of scientific innovations for better patient care.
Ultimately, the objective is to produce pilot data on the imputability of POPs in infertility
and in the pathophysiology of endometriosis in order to reflect on the implementation of
preventive measures in infertile women. Identifying exposures to chemical substances and
their physiopathological role can help to control their risks and lead to a reflection on the
implementation of preventive measures. In case of convincing results, a metabolomic approach
will be carried out in order to study the underlying pathogenic mechanisms but also to
identify clinical biomarkers. The objective of this project is an integrative multi-omic
approach with the ambition to reveal mechanistic associations as well as possible biomarkers
of effect on the theme of endometriosis and associated infertility.
This is an observational monocentric non-interventional prospective exploratory study on
matched case-control questionnaire and biocollection, in the Reproductive Biology department
and in the Gynaecology department of the University Hospital of Nantes.
The biocollection "Obstetrics, Gynaecology and Reproduction", was submitted to the CPP and
the CNIL and declared to the Ministry of Research, as well as the informed consent proposed
to patients included in our study.
The recruitment of participants is carried out in parallel by the gynaecology department for
Groups 1 and 2, and the Reproductive Medicine department for Groups 3, 4 and 5.
The analyses will be carried out by LABERCA. The concentration levels of contaminants will be
analyzed by the usual techniques of the LABERCA Laboratory and described in pg or ng per gram
of lipid (pg or ng g-1 l w) according to the conventions in force in this field of
measurement of lipophilic contaminants, but also in pg or ng per gram of tissue (pg or ng -1
fw) to take into account a mode of expression of the results bearing a complementary level of
information The conformity of the analyzed sample and the measurement will be validated by
the LABERCA. Measurements of chemical contaminants in the samples from the study will be
carried out blindly, and randomly. The analytical methods used by LABERCA to measure the
different families of environmental contaminants targeted in this study (historical
contaminants such as dioxins, PCBs, PFAS, organochlorine pesticides, or more emerging such as
brominated flame retardants, phthalates or bisphenols), are based on high-resolution mass
spectrometry-chromatography (GC-HRMS, GC-MS/MS or LC-MS/MS) and isotopic dilution
quantification (internal calibration with 13C-labelled compounds), which represents the
highest current standard in this field.
The chemical analysis of metabolomic and lipidomic profiles will be performed on the LABERCA
metabolomic platform. The platform has developed liquid chromatography methods coupled with
high resolution mass spectrometry (LC-HRMS) for non-target profiling from various biological
matrices. The analyses will be carried out within an accredited quality management system
(ISO 9001 and IBISA)
