Analysis of Vitamin D and VDR Expression in Endometriosis: A Case-Control Study (NCT06289257) | Clinical Trial Compass
CompletedNot Applicable
Analysis of Vitamin D and VDR Expression in Endometriosis: A Case-Control Study
Thailand108 participantsStarted 2024-05-06
Plain-language summary
The goal of this cross-sectional prospective matching study is to evaluate whether serum vitamin D levels and vitamin D receptor (VDR) expression are associated with the presence and severity of endometriosis in women of reproductive age.
The main questions it aims to answer are:
* Is there a difference in serum 25-hydroxyvitamin D \[25(OH)D\] levels between women with endometriosis and healthy controls?
* Is there a correlation between serum vitamin D levels and VDR expression in endometriotic tissues?
* Is there an association between vitamin D status and the severity of endometriosis based on the revised American Society for Reproductive Medicine (rASRM) staging?
Researchers will compare participants with endometriosis to matched healthy controls (1:2 ratio).
Participants will:
* Provide blood samples for serum 25(OH)D measurement.
* Undergo surgical tissue sampling (for the endometriosis group) to assess VDR expression using immunohistochemistry staining.
* Complete structured questionnaires regarding sun exposure, lifestyle, and clinical characteristics.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria Endometriosis Group:
* Women diagnosed with ectopic endometriotic tissue:
* Have a scheduled surgery appointment at Sri Nakarin Hospital.
* Are aged 18 years or older.
Inclusion Criteria Control Group:
* Women undergoing examination at the outpatient department of Sri Nakarin Hospital.
* No history of gynecological diseases or previous treatment for gynecological conditions associated with lower abdominal pain, infections, or abdominal masses at present.
* Have undergone a gynecological examination within the past year, or if examined during the current visit, the results were normal.
* Have undergone an ultrasound examination within the past year, or if examined during the current visit, the ultrasound results were normal.
Exclusion Criteria:
* Received vitamin D supplements within the past 3 months prior to volunteering.
* History of chronic infectious diseases.
* Previously treated for autoimmune diseases.
* History of polycystic ovarian.
* History of bone disorders or receiving medications affecting bones.
* Irregular menstrual cycles or absence of menstruation for more than 3 months up to 1 year.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.