Health Condition 1: N809- Endometriosis, unspecified
Conditions
Interventions
Intervention1: Endometriosis group with Tab Cabergoline.: Tab Cabergoline 0.5mg twice a week for 4 months
Control Intervention1: Endometriosis group without intervention: NIL
Sponsors
AIIMS new delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women aged 18 40 years. 2. Diagnosed with endometriosis 3. Scheduled for elective endometriosis surgery.
Exclusion criteria
Exclusion criteria: 1. Prior hormonal or immunomodulatory therapy in the last 3 months. 2. Known pituitary or hypothalamic disorders. 3. Significant hepatic or renal impairment. 4. Pregnancy or lactation. 5. Known allergy to Cabergoline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 1. At Enrollment 2. Pre-operative(after 4months of intervention drug) 3. Intraoperative | — |
Secondary
| Measure | Time frame |
|---|---|
| Cytokine Comparison: Mean difference in Interleukin-6 (IL-6) concentration (pg/mL). Mean difference in Interleukin-8 (IL-8) concentration (pg/mL). in peritoneal fluid between the study groups.Timepoint: Intra-operative;For Hematological Comparison: Mean difference in hs-CRP Mean difference in S. Ferritin Mean difference in CA-125 Timepoint: Enrollment Preoperative (after 4 month intervention);For Disease Severity Correlation: Correlation coefficient between the level of each cytokine and the revised American Association of Gynecologic Laparoscopists (AAGL) stage for endometriosis.Timepoint: Intraoperative;For Ovarian Reserve Impact: The absolute change in serum Anti-M llerian Hormone (AMH) level (ng/mL) from baseline to 4 month preoperativeTimepoint: Enrollment Preoperative (after 4 month intervention);For Surgical Feasibility Total operative time (minutes). Intra-operative estimated blood loss (mL). Surgeons Visual Analog Scale (VAS) score for ease of dissection (0-10)Timepoint: Intraoperative;For Symptom Response: The absolute change in patient-reported pelvic pain VAS score (0-10) from baseline to the day of surgery.Timepoint: Enrollment Preoperative (after 4month of intervention) | — |
Countries
India
Contacts
Public ContactBhupinder Deep Kaur
AIIMS, New Delhi
Outcome results
None listed