NCT06356753|Completed
EndoxOmics : Exposome, Endometriosis and Fertility
EndoxOmics
Association Between Chemical Exposome, Endometriosis and Infertility by an Integrative Approach
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EndoxOmics
Association Between Chemical Exposome, Endometriosis and Infertility by an Integrative Approach
Sponsor study identifier
observational
87
1 country
1
Study Start
September 1, 2019
Actual (reported)Primary Completion
March 31, 2021
Actual (reported)Study Completion
March 31, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2019
Actual (reported)March 31, 2021
Actual (reported)March 31, 2021
Actual (reported)March 29, 2024
Actual (reported)April 10, 2024
Actual (reported)Identify endogenous molecular profiles of patients with infertile endometriosis
Statistical associations between exposomics and presence of deep endometriosis with infertility
baseline
Characterize the internal chemical exposure profiles and metabolomic profiles in the different groups.
baseline
Compare the distribution of contaminant concentration levels and metabolomic profiles according to the media measured.
baseline
Group recruited from the gynaecology/obstetrics department : Women without deep endometriosis benefiting surgery. * Caucasian women, aged 18 to 45 years undergoing gynaecological surgery, for example: benign laparoscopy (example: tubal ligation), benign ovarian surgeries or benign uterine procedures (fibroma, ovarian cyst) or genital prolapse. * Non-interventional access to parietal and epiploic adipose tissue as part of routine care * No clinical-biological criteria in favour of a diagnosis of endometriotic disease, nor any radiological evidence (ultrasound or MRI) suggestive of endometriosis.
Group recruited from the gynaecology/obstetrics department : Women with endometriosis benefiting surgery. * Caucasian women aged 18 to 45 * Severe and deep endometriotic pathology, with or without endometriomas, with surgical indication (clinical examination, imaging examinations, intraoperative observation), * Access to epiploid and/or parietal adipose tissue as part of routine care.
Group recruited from the Reproductive Medicine Department : Infertile Women with deep endometriosis benefiting from IVF. * Women with IVF or ICSI for infertility with deep endometriosis diagnosed in routine care (clinical examination, imaging examinations +/- surgical findings). They will be classified into 2 subgroups: 1) deep endometriosis without endometrioma and 2) deep endometriosis associated with endometriomas. * Access to follicular fluid as part of routine care during oocyte retrieval and access to serum as part of routine care during gonadotropin follicular stimulation.
Women recruited in the Gynaecology-Obstetrics and Reproductive Medicine Departments
Nantes University Hospital
Nantes, Loire-Atlantique, 44093, France
87 participants (actual enrollment reported by the registry).
First Submitted
March 29, 2024
First Posted
April 10, 2024
Study Start
September 1, 2019
Actual (reported)ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Group recruited from the Reproductive Medicine Department : Infertile women without endometriosis receiving IVF+/-ICSI. * Women, aged 18-43 receiving IVF± ICSI for female infertility * No history of endometriosis or suggestive clinical-biological or radiological signs. * The etiology of infertility will be determined in reproductive medicine. Women will be divided into 2 groups of patients: 1. PCOS (Polycystic Ovary Syndrome). PCOS will be diagnosed in routine care (interrogation, clinical examination, hormone test and pelvic ultrasound) according to the criteria of the Rotterdam Consensus Conference reviewed in 2018. 2. IOD (Early Ovarian Failure). IOD will be diagnosed in routine care (clinical examination, hormonal and ultrasound check-up) according to the following criteria: AMH\<0.8ng/ml and/or CFA \<6 * Access to follicular fluid as part of routine care during oocyte retrieval and access to serum as part of routine care during gonadotropin follicular stimulation
Group recruited from the Reproductive Medicine Department : Fertile women without endometriosis receiving IVF-ICSI as oocyte donors. * Women receiving IVF± ICSI as oocyte donors * No history of endometriosis or clinical-biological or radiological signs suggestive of endometriosis. * Access to follicular fluid will be part of the standard care for oocyte puncture and access to serum will be part of the standard care for gonadotropin follicular stimulation.
Contact the study team to confirm eligibility.
Primary Completion
March 31, 2021
Actual (reported)Study Completion
March 31, 2021
Actual (reported)Last Updated
April 10, 2024
Record last verified: 2024-04
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