Pilot Study to Characterize the Endometriosis Steroidome and Its Link to Endocrine Disruptors and Vaginal Dysbiosis
Recruiting · NCT06820450 · Observational (researchers observe without assigning treatment) · Lead sponsor: Nantes University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Blood testurine samplevaginal sample
What this trial is about
Endometriosis is a systemic, steroid-dependent, inflammatory disease characterized by the growth of endometrial-like tissue outside the uterus, affecting approximately 10 % of women of childbearing age. The etiology and pathophysiology of endometriosis is not completely understood to support effective treatment and prevention strategies. Despite the steroid dependency, little is known concerning the underlying metabolism of estrogen and other tightly related steroids. Moreover, shortening the long diagnostic delays is a major priority in endometriosis research.
Who can take part
Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Women aged 18 to 45
- Free, informed and written consent from the patient to participate in the study
- Good understanding of the French language
- Patient affiliated to or benefiting from a social security or similar scheme
- Specific inclusion criteria for each group:
- Group 1. Controls.
- Women with no laparoscopically confirmed signs suggestive of deep endometriosis.
- No clinico-biological criteria in favour of a diagnosis of endometriotic disease, nor any radiological signs (ultrasound or MRI) suggestive of endometriosis.
- Group 2. Cases of deep endometriosis.
- Newly diagnosed women (less than 12 months).
- Severe, deep endometriotic pathology with surgical indication (clinical examination, imaging tests, pre-operative findings).
Exclusion criteria
- Intercurrent diagnosis of pregnancy.
- Presence of other hormone-dependent pathologies (e.g. breast cancer, PCOS).
- Acute infection.
Where it is running
1 location listed.
- CHU de Nantes - Nantes, France