Hôpital Foch
Suresnes, 92150, France
NCT Number: NCT07652593
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
Suresnes, 92150, France
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Collection of blood samples, endometrial samples, vaginal microbiota samples, and surgical specimens when clinically indicated for immunological and biomarker analyses.
Time frame: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
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)
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)
Evaluation of interactions between endometrial cells and NK cells using tissue-based analyses.
Time frame: Following sample collection, up to study completion (16 months)
Evaluation of the effects of cytokine stimulation on NK cell function and endometrial cell responses in laboratory assays.
Time frame: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
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)
Correlation between clinical features of endometriosis and immunological findings.
Time frame: At sample collection and laboratory analysis up to study completion (16 months)
Assessment of associations between genetic markers and immunological findings.
Contact information is provided by the study sponsor or research team.
Hopital Foch
Other
Interaction Between Decidual Cells and Natural Killer Cells in Endometriosis: A Prospective Pilot Case-Control Study
Acronym: PAINLESS
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