Interaction Between Decidual Cells and NK Cells in Endometriosis
ConditionEndometriosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHopital Foch
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Current infection.
Active cancer.
Active autoimmune disease.
Concomitant hormonal treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
Biological Sample Collection
Procedure/SurgeryCollection of blood samples, endometrial samples, vaginal microbiota samples, and surgical specimens when clinically indicated for immunological and biomarker analyses.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Endometriosis GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: