Interaction Between Decidual Cells and NK Cells in Endometriosis
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
- The protocol lists: Biological Sample Collection.
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: from 18 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
Interaction Between Decidual Cells and Natural Killer Cells in Endometriosis: A Prospective Pilot Case-Control Study
Overview
Endometriosis is a chronic gynecological disease characterized by the presence of endometrial-like tissue outside the uterus and is frequently associated with pelvic pain and infertility. Increasing evidence suggests that immune dysfunction may contribute to the development and persistence of the disease. The purpose of this prospective case-control study is to compare immune cell characteristics in women with deep endometriosis and women without endometriosis during the secretory phase of the menstrual cycle. Participants will undergo collection of clinical data, blood samples, endometrial samples, and vaginal microbiota samples. For participants undergoing clinically indicated pelvic surgery, additional biological samples may be collected during the procedure. The study aims to improve understanding of the immune mechanisms involved in endometriosis and to identify potential biomarkers associated with the disease.
Detailed description
Endometriosis affects approximately 10-15% of women of reproductive age and represents a major public health concern. Despite its high prevalence, the pathophysiological mechanisms underlying the disease remain incompletely understood. Increasing evidence suggests that alterations in the immune environment of the endometrium may contribute to the establishment and progression of endometriosis. In particular, uterine immune cells may play a role in regulating local inflammation and tissue homeostasis. Characterizing these immune mechanisms may improve understanding of disease development and identify potential biomarkers associated with endometriosis.
PAINLESS is a prospective, single-center, pilot case-control study conducted at Foch Hospital (Suresnes, France). The study will enroll 50 adult women, including 25 participants with confirmed deep endometriosis and 25 control participants without endometriosis.
Biological samples will be collected during the secretory phase of the menstrual cycle (days 16-24). Depending on clinical management, study procedures may include:
* Collection of demographic and clinical data * Assessment of symptoms and quality of life * Blood sampling * Endometrial sampling * Vaginal microbiota sampling * Collection of additional biological specimens during clinically indicated pelvic surgery.
Biological samples will be analyzed to characterize immune cell populations, evaluate soluble immune mediators, investigate associations with hormonal and clinical parameters, and explore biological mechanisms involved in endometriosis.The primary objective is to compare the expression of immune-related markers in endometrial and peritoneal samples obtained from women with endometriosis and controls. Secondary objectives include characterization of immune cell phenotypes and functions, evaluation of immune-related soluble factors, investigation of interactions between immune and endometrial cells, assessment of correlations with hormonal and clinical data, exploratory genetic analyses, and creation of a vaginal microbiota biobank. Results from this pilot study are expected to provide preliminary data for future research aimed at improving the understanding, diagnosis, and management of endometriosis.
Interventions
- Procedure Biological Sample Collection
Collection of blood samples, endometrial samples, vaginal microbiota samples, and surgical specimens when clinically indicated for immunological and biomarker analyses.
Primary outcome measures
- CD39 Expression on Natural Killer Cells in Endometrial and Peritoneal Samples [Time frame: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)]
Secondary outcome measures (6)
- NK Cell Cytotoxic Function [Time frame: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)]
- Endometrial and NK Cell Interactions [Time frame: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)]
- Ex Vivo Modulation of NK Cell Function [Time frame: Following sample collection, up to study completion (16 months)]
- Association Between Hormonal Levels and NK Cell Profile [Time frame: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)]
- Association Between Clinical Characteristics and Immune Markers [Time frame: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)]
- Genetic Biomarker Associations [Time frame: At sample collection and laboratory analysis up to study completion (16 months)]
Eligibility criteria
Inclusion criteria
- Endometriosis Group
- Female participant aged 18 years or older.
- Confirmed diagnosis of deep endometriosis by imaging or surgery.
- Pelvic pain and/or severe dysmenorrhea (Visual Analog Scale > 4).
- Premenopausal.
- No contraceptive or hormonal treatment during the study menstrual cycle.
- Affiliated with a health insurance system.
- Able and willing to provide written informed consent.
- Control Group
- Female participant aged 18 years or older.
- No diagnosis of endometriosis.
- Premenopausal.
- No contraceptive or hormonal treatment during the study menstrual cycle.
- No chronic pelvic pain or severe dysmenorrhea (Visual Analog Scale < 4).
- Affiliated with a health insurance system.
- Able and willing to provide written informed consent.
Exclusion criteria
- Current infection.
- Active cancer.
- Active autoimmune disease.
- Concomitant hormonal treatment.
- Pregnancy.
- Participant under guardianship or legal protection.
- Participant deprived of liberty.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Hôpital Foch — Suresnes
Identifiers
NCT: NCT07652593 · 2024_0074