Effect of preoperative cabergoline therapy on peritoneal fluid inflammatory markers in women undergoing endometriosis surgery, a pilot study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The mean difference in the concentration of Vascular Endothelial Growth Factor (VEGF) in peritoneal fluid (pg/mL) and Tumor Necrosis Factor-alpha (TNF-alpha) between the intervention and control groups at the time of surgery.
研究概览
简要总结
This is a pilot study at AIIMS, New Delhi, investigating the effect of preoperative Cabergoline on women with endometriosis related infertility.
Design: 90 women will be divided into three groups
Group A (Intervention): 30 endometriosis patients taking Cabergoline 0.5mg biweekly for 4 months before surgery.
Group B (Disease Control): 30 endometriosis patients receiving no pre-operative drugs.
Group C (Non-Disease Control): 30 women without endometriosis undergoing surgery for other reasons(benign ovarian cyst, tubal ligation)
Primary Goal: To compare the levels of a key protein VEGF(Vascular endothelial growth factor) and TNF alpha (Tumor Necrosis Factor Alpha) in peritoneal fluid between the groups after the intervention.
The study will measure various blood and pain markers before and after the 4-month period. During surgery, peritoneal fluid will be collected to analyze inflammatory markers, with the lab staff blinded to the group assignments.
Statistical tests will determine if the differences in outcomes between the groups are significant.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged 18–40 years.
- •Diagnosed with endometriosis
- •Scheduled for elective endometriosis surgery.
排除标准
- •Prior hormonal or immunomodulatory therapy in the last 3 months.
- •Known pituitary or hypothalamic disorders.
- •Significant hepatic or renal impairment.
- •Pregnancy or lactation.
- •Known allergy to Cabergoline.
结局指标
主要结局
The mean difference in the concentration of Vascular Endothelial Growth Factor (VEGF) in peritoneal fluid (pg/mL) and Tumor Necrosis Factor-alpha (TNF-alpha) between the intervention and control groups at the time of surgery.
时间窗: 1. At Enrollment | 2. Pre-operative(after 4months of intervention drug) | 3. Intraoperative
次要结局
- Cytokine Comparison:(Mean difference in Interleukin-6 (IL-6) concentration (pg/mL).)
- For Hematological Comparison:(Mean difference in hs-CRP)
- For Disease Severity Correlation:(Correlation coefficient between the level of each cytokine and the revised American Association of Gynecologic Laparoscopists (AAGL) stage for endometriosis.)
- For Ovarian Reserve Impact:(The absolute change in serum Anti-Müllerian Hormone (AMH) level (ng/mL) from baseline to 4 month preoperative)
- For Surgical Feasibility(Total operative time (minutes).)
- For Symptom Response:(The absolute change in patient-reported pelvic pain VAS score (0-10) from baseline to the day of surgery.)
研究者
Bhupinder Deep Kaur
AIIMS, New Delhi