Identifying biomarkers for endometriosis using menstrual blood
RECHERCHE DE MARQUEURS DIAGNOSTIQUES ET PRONOSTIQUES DE L'ENDOMETRIOSE DANS LE SANG DES REGLES CHEZ LES FEMMES EN AGE DE PROCREER
This study is trying to find markers in menstrual blood that can help diagnose and understand endometriosis in women aged 18-45, both those with the condition and those without.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 1 site (Paris) |
| Trial ID | NCT06245512 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify diagnostic and prognostic biomarkers for endometriosis by analyzing menstrual blood, a readily accessible biological fluid. Women aged 18-45, both with and without endometriosis, will provide menstrual blood samples using a menstrual cup, with some participants also undergoing surgery for their condition. The study will compare the menstrual blood of women affected by endometriosis to those without the condition, as well as before and after surgical treatment, to identify significant differences that could aid in diagnosis and prognosis.
Who should consider this trial
Good fit: Ideal candidates include women aged 18-45 who have their period and reside or work in the Ile de France area, with some having a diagnosis of endometriosis.
Not a fit: Patients with autoimmune diseases or chronic conditions other than endometriosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for endometriosis, allowing for earlier and more accurate identification of the condition.
How similar studies have performed: While the approach of using menstrual blood for biomarker identification is relatively novel, similar studies have shown promise in identifying biomarkers for other conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Paris
- Hopital Cochin — Paris, France (Recruiting)
Study contacts
- Principal investigator: Louis Marcellin — Institut National de la Santé Et de la Recherche Médicale, France
- Study coordinator: Ludivine Doridot
- Email: ludivine.doridot@inserm.fr
- Phone: 33(0)1 40 51 64 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.