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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
50
Collection of blood samples, endometrial samples, vaginal microbiota samples, and surgical specimens when clinically indicated for immunological and biomarker analyses.
Hôpital Foch
Suresnes, France
CD39 Expression on Natural Killer Cells in Endometrial and Peritoneal Samples
Comparison of CD39 expression on natural killer (NK) cells in endometrial and peritoneal samples collected from women with deep endometriosis and women without endometriosis.
Time frame: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
NK Cell Cytotoxic Function
Assessment of NK cell cytotoxic activity through degranulation markers and cytokine production in biological samples.
Time frame: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
Endometrial and NK Cell Interactions
Evaluation of interactions between endometrial cells and NK cells using tissue-based analyses.
Time frame: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
Ex Vivo Modulation of NK Cell Function
Evaluation of the effects of cytokine stimulation on NK cell function and endometrial cell responses in laboratory assays.
Time frame: Following sample collection, up to study completion (16 months)
Association Between Hormonal Levels and NK Cell Profile
Correlation of estrogen and progesterone levels with NK cell characteristics and immune markers.
Time frame: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
Association Between Clinical Characteristics and Immune Markers
Correlation between clinical features of endometriosis and immunological findings.
Time frame: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
Genetic Biomarker Associations
Assessment of associations between genetic markers and immunological findings.
Time frame: At sample collection and laboratory analysis up to study completion (16 months)
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