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NCT Number: NCT06245512

Diagnostic and Prognostic Markers of Endometriosis in Menstrual Blood

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.

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Key information

Conditions

Endometriosis Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Hopital Cochin

Paris, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Diagnostic and prognostic score

    Time frame: 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%.

Secondary outcomes

  1. Diagnostic score

    Time frame: 3 years and 8 months

    Score based on candidate biomarkers that will be selected for their quantitative differences between patients with or without endometriosis.

  2. Prognostic candidate score

    Time frame: 3 years and 8 months

    Score based on candidate biomarkers that will be selected for their significant quantitative differences between before and after surgery. This score will have to be validated in a bigger cohort in a subsequent clinical study to assess its specificity and sensitivity to differentiate women for who the surgery is effective from women for who the surgery is not or only partially effective, or women with a recurrence of the disease.

  3. Diagnostic score for a specific subtype of endometriosis

    Time frame: 3 years and 8 months

    Score based on candidate biomarkers that will be selected for their quantitative differences between the patients with different subtypes of endometriosis. 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 a specific subtype of endometriosis with a specificity greater than or equal to 79% and a sensitivity greater than or equal to 94%.

Study contacts

Contact information is provided by the study sponsor or research team.

Ludivine Doridot

CONTACT

[email protected]

33(0)1 40 51 64 33

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

RECHERCHE DE MARQUEURS DIAGNOSTIQUES ET PRONOSTIQUES DE L'ENDOMETRIOSE DANS LE SANG DES REGLES CHEZ LES FEMMES EN AGE DE PROCREER

Acronym: MultiMENDo

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 7, 2024
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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