EndoxOmics : Exposome, Endometriosis and Fertility

NCT06356753 | Completed

• 1 other identifier: RC19_0203
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis; Infertility, Female

Keywords

Exposome; Endometriosis; Infertility

Outcome Measures

Primary Outcomes (1)

• Identify endogenous molecular profiles of patients with infertile endometriosis

  Statistical associations between exposomics and presence of deep endometriosis with infertility

  baseline

Secondary Outcomes (2)

• 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

Study Arms (5)

1-Women without deep endometriosis benefiting surgery

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.

2-Women with endometriosis benefiting surgery

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.

3-Infertile Women with deep endometriosis benefiting from IVF

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.

4-Infertile Women w/o endometriosis receiving IVF+/-ICSI

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

5-Fertile W. w/o endometriosis receiving IVF-ICSI as oocyte

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women recruited in the Gynaecology-Obstetrics and Reproductive Medicine Departments

You may qualify if:

• Women aged 18 to 45 years benefiting from surgery in the Gynaecology-Obstetrics department or IVF± ICSI (In Vitro Fertilization+/- Intracytoplasmic Injection of Spermatozoid) in the Medicine and Reproductive Biology department of the University Hospital of Nantes.
• No objection to participate in the study
• Collection of consent for the Gynaecology-Obstetrics Bio-collection
• Group 1 - 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 2 - 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 3 - 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.
• Group 4 - Infertile women without endometriosis receiving IVF+/-ICSI :

You may not qualify if:

• Opposition from the patient.
• Intercurrent diagnosis of pregnancy incompatible with surgery or IVF+/-ICSI
• Clinical or radiological signs suggestive of endometriosis
• Opposition from the patient.
• Intercurrent diagnosis of pregnancy incompatible with surgery or IVF+/-ICSI

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

MeSH Terms

Conditions

Endometriosis; Infertility, Female; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 10, 2024
• Study Start: September 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)