Pilot Study to Characterize the Endometriosis Steroidome and Its Link to Endocrine Disruptors and Vaginal Dysbiosis

ConditionEndometriosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Intercurrent diagnosis of pregnancy.

Presence of other hormone-dependent pathologies (e.g. breast cancer, PCOS).

Acute infection.

Trial population

The STERONLINE study population will be made up of women aged between 18 years and 45 years * 45 patients with endometrioma * 45 patients without endometrioma

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Blood test

    Other intervention

    A blood test (2 x 5 ml dry tubes) will be taken to analyze steroid profiles

  • urine sample

    Other intervention

    a 20 ml urine sample will be taken to analyze steroid profiles

  • vaginal sample

    Other intervention

    to characterize the microbiota.

Treatment groups

135 Participants
are divided into 2 treatment groups
Group A: Group 1. Controls (n=45)3 interventions
Group B: Group 2. Deep endometriosis (n = 90)3 interventions

Trial outcomes

Primary outcomes

1

Identify steroid profiles associated with endometriosis

Statistical associations between steroids and the presence of endometriosis.

Time frame
Sampling at inclusion visit

Secondary outcomes

1

Identify biomarkers of environmental chemical exposure associated with endometriosis and steroid profiles.

Statistical difference between environmental chemical and steroid exposure profiles between subgroups of the study populations.

Time frame
Sampling at inclusion visit
2

Identify the role of vaginal microbiota dysbiosis on hormonal alteration in endometriosis

Presence of a specific bacterial community in the vaginal microbiota

Time frame
Sampling at inclusion visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.