Endometriosis and Brominated Flame Retardant (ENDOTOX Study)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Endometriosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02651077

RC13_0380

Details and patient eligibility

About

The investigators wish to highlight, in a Case-Control design, if there is an increased concentration of BFRs in omental adipose tissue of cases ( women with severe endometriosis with surgical indication ) versus bioaccumulation recorded in a control cohort ( women recruited in obstetrics and gynecology or visceral surgery showing no sign of endometriosis ) . Pairing will be operate on Age (+/- 5 years compared to the case ) , BMI ( BMI 5 Classes described by the HAS) and previous breastfeeding experience (yes / no , opposite the release expected bioaccumulate contaminants in breast adipose tissue , when the lactation ) .

Enrollment: 76 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criterion for de cases :

• Age : 18-45 years old
• Deep endometriosis with or without endometriomas that need surgery (clinical examination, MRI, surgery)
• Accessing to the omental and/or parietal adipose tissue
• Non opposition of the patients for the samples collection and consent for the present study.

Inclusion criterion for the controls :

• Patients without any history of endometriosis and without suggestive symptomatology. Often patients operated for cesarean section.
• Possible access to the adipose tissue of the omentum or abdominal wall

Exclusion criterion for the cases :

• Pregnancy
• Death

Exclusion criterion for controls :

• Pregnancy
• Death

Trial design

76 participants in 2 patient groups

Case Group

Description:

38 women with severe and deep endometriosis, aged 18 to 45 years old and hospitalized at Nantes University Hospital for surgical indication of endometriosis lesions ablation.

Control Group

Description:

38 women aged 18 to 45 years old without suggestive signs of endometriosis