Understanding Neural Immune Mechanisms and Genetic Influences on Chronic Pelvic Pain in Women with Endometriosis
This study aims to observe and understand the menstrual dynamics of systemic cytokine expression in endometriosis, focusing on measuring the expression of pro-inflammatory cytokines, stem cells, immunologic activity, and neurotransmitters in endometriosis lesions and the endometrium in women with chronic pelvic pain.
Data Collection
Collected from today forward - ProspectiveUrogenital Diseases+3
+ Genital Diseases
+ Endometriosis
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: April 22, 2004
Actual date on which the first participant was enrolled.Endometriosis, a condition where endometrial tissue grows outside the uterus, often leads to chronic pelvic pain in women during their reproductive years. This study aims to deepen our understanding of this pain and discover new treatment methods. Not all women with endometriosis experience pain, and some feel pain in areas not related to the disease location. Current treatments, which involve altering hormone levels or surgically removing endometriosis tissue, only provide temporary relief. This suggests that the current approach to classifying and treating pain may not be sufficient. The study will explore how sex hormones, pain processing, immune system substances, and pain-related genes interact to cause chronic pelvic pain in women with endometriosis. Participants in this observational study will undergo various assessments. The study will measure changes in hormonal and immune substances in the blood, endometriosis lesions, and normal endometrial tissue. It will also evaluate the role of the nerve, muscle, and skeletal systems in pelvic pain through a comprehensive pain assessment. Additionally, the study will investigate how stress hormones may contribute to chronic pain. The primary outcome includes evaluating menstrual cycle variation in systemic secretion of inflammatory mediators (IL-6) and hormones, estradiol and progesterone. The study will also measure the expression of pro-inflammatory cytokines, stem cells, immunologic activity, and neurotransmitters in endometriosis lesions and the endometrium.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.78 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center
Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps