Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-24 @ 7:04 PM
NCT ID:
NCT06289257
Brief 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.
Detailed Description:
This cross-sectional study aims to investigate the association between serum vitamin D levels and endometriosis, and to further explore the expression of vitamin D receptor (VDR) in endometriotic tissues using immunohistochemistry.
The study enrolled reproductive-aged women diagnosed with endometriosis who underwent laparoscopic surgery and compared them with matched healthy controls based on age and BMI.
Serum levels of 25-hydroxyvitamin D \[25(OH)D\] were measured using a standardized laboratory assay. Endometriotic tissue samples obtained during surgery were analyzed for VDR expression, qualitative-quantified using the H-score method in both stroma and epithelial compartments. Clinical data, including revised American Society for Reproductive Medicine (rASRM) staging, were used to assess disease severity. Additional data were collected via structured interviews covering sun exposure, reproductive history, lifestyle, and hormonal treatment.
Tissue staining and scoring were reviewed by two blinded pathologists to ensure reproducibility. Data entry validation was performed by cross-checking case report forms with original clinical records, and double data entry methods were used to minimize errors.
Sample size was determined based on prior effect size estimates from published literature, aiming to achieve a power of 80% and significance level of 5%. The study population was sufficient to detect a clinically meaningful difference in vitamin D status between cases and controls.
Missing data were managed using complete case analysis and sensitivity checks. For secondary outcomes, subgroup analyses were conducted based on categorized vitamin D levels (normal, insufficiency, deficiency, severe deficiency).
Statistical analysis included:
* Descriptive statistics for demographic and clinical characteristics.
* Conditional logistic regression or non-parametric equivalents for between-group comparisons.
* Logistic regression models to estimate the odds ratios for severe endometriosis by vitamin D status.
* Correlation analyses between serum vitamin D levels, VDR expression (H-scores), and rASRM scores.
All analyses were performed using STATA version 18.5. The findings aim to clarify the potential role of vitamin D and its receptor in endometriosis pathogenesis and to inform future interventional studies and clinical practice.
Study:
NCT06289257
Study Brief:
Protocol Section:
NCT06289257