Diagnostic and Prognostic Markers of Endometriosis in Menstrual Blood
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
RECHERCHE DE MARQUEURS DIAGNOSTIQUES ET PRONOSTIQUES DE L'ENDOMETRIOSE DANS LE SANG DES REGLES CHEZ LES FEMMES EN AGE DE PROCREER
Overview
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.
Primary outcome measures
- Diagnostic and prognostic score [Time frame: 3 years and 8 months]
Secondary outcome measures (3)
- Diagnostic score [Time frame: 3 years and 8 months]
- Prognostic candidate score [Time frame: 3 years and 8 months]
- Diagnostic score for a specific subtype of endometriosis [Time frame: 3 years and 8 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- Hopital Cochin — Paris
Identifiers
NCT: NCT06245512 · C22-75 · 2023-A01857-38