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Clinical Trials in France / NCT06245512
Recruiting Observational

Diagnostic and Prognostic Markers of Endometriosis in Menstrual Blood

NCT06245512 · tracked via the Priya Life Science France tracker
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Phase
Observational
Started
2024-07-31
Last updated
2026-04-16

Condition(s) studied

Endometriosis

Study summary

The goal of this observational study is to identify diagnostic and prognostic biomarkers for endometriosis using menstrual blood, an easily accessible yet overlooked biological fluid in women of reproductive age, affected or not by endometriosis

The main questions it aims to answer are:

* are there relevant differences in the menstrual blood of women affected by endometriosis compared to women without endometriosis?
* do some of these differences disappear or lessen when the disease is treated by surgery? Participants will answer questions relevant to endometriosis and provide menstrual blood 1 to 3 times (self-collected with a menstrual cup). A subgroup of participants affected by endometriosis that will undergo surgery for their regular care will provide menstrual blood before and after their surgery.

Researchers will compare the menstrual blood of women with and without endometriosis, and before and after surgery to see if they can identify significant differences.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria: For all participants: Women 18-45 of age who * Have their period * Have given their written consent * Have already used a menstrual cup as a method of hygienic protection * Residing or working in Ile de France (Paris Metropolitan area, France) For participants with endometriosis: * diagnosis of endometriosis established by surgery or imaging (ultrasound and/or MRI) * presence of one or more painful symptoms \> 3 on a visual scale (dysmenorrhea and/or dyspareunia and/or chronic pelvic pain) and/or infertility * for the surgery subgroup: planned surgery in the next 3 months For participants without endometriosis: * painful symptoms \< or equal to 3 on a visual scale (for dysmenorrhea and dyspareunia and chronic pelvic pain), * absence of intense period pain in adolescence (leading to taking pills to control this pain and/or peri-menstrual school absenteeism) Exclusion Criteria: For all participants: * Autoimmune diseases * Chronic diseases other than endometriosis (diabetes, hypertension) * A person who is the subject of a judicial safeguard measure (by declaration) * Infectious diseases (HIV, HBV, if known) * History of menstrual toxic shock syndrome For patients with endometriosis: * endometriosis surgery within the last 3 months.

Primary outcome measure(s)

  • Diagnostic and prognostic score — 3 years and 8 months
    Score based on candidate biomarkers that will be selected for their quantitative differences between patients with or without endometriosis and for their prognostic potential in the context of response to surgical treatment (significant quantitative difference between before and after surgery). Biomarkers that are both significantly quantitatively different between women with and without endometriosis and before versus after surgery will constitute the final set and this set will be measured by targeted approach in all the participants. This score, associated or not with clinical characteristics (such as for example the intensity of pain, the association of different types of pain), will make it possible to differentiate women with and without endometriosis with a specificity greater than or equal to 79% and a sensitivity greater than or equal to 94%.

Trial sites (1)

FacilityCityRegionStatus
Hopital Cochin Paris France Recruiting

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Other trials for the same condition

Impact of Surgery for Deep Posterior Endometriosis on Ovarian Reserve (ENDORO) Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06245512 on ClinicalTrials.gov ↗ ← All trials in France