NCT06245512 Diagnostic and Prognostic Markers of Endometriosis in Menstrual Blood
| NCT ID | NCT06245512 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
| Condition | Endometriosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-07-31 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2024-07-31 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Louis Marcellin
PRINCIPAL INVESTIGATOR
Institut National de la Santé Et de la Recherche Médicale, France
Frequently Asked Questions
Who can join the NCT06245512 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06245512 currently recruiting?
Yes, NCT06245512 is actively recruiting participants. Contact the research team at ludivine.doridot@inserm.fr for enrollment information.
Where is the NCT06245512 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06245512 clinical trial?
NCT06245512 is sponsored by Institut National de la Santé Et de la Recherche Médicale, France. The principal investigator is Louis Marcellin at Institut National de la Santé Et de la Recherche Médicale, France. The trial plans to enroll 250 participants.