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Completed

NCT Number: NCT02651077

Endometriosis and Brominated Flame Retardant (ENDOTOX Study)

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 ) .

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Concentrations of brominated flame retardant (BFR) in adipose tissue and serum

    Time frame: baseline

Secondary outcomes

  1. Concentrations of dioxins in adipose tissue and serum

    Time frame: baseline

  2. Concentrations of polychlorinated biphenyls (PCBs),

    Time frame: baseline

  3. Concentrations of organochlorine pesticides (OCPs) in adipose tissue and serum

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • ONIRIS

Registry information

Official study title

Looking for a Link Between Endometriosis and Exposure to Lipophilic Environmental Chemicals Like Brominated Flame Retardant (ENDOTOX Study)

Acronym: ENDOTOX

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 8, 2016
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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