| CTRI Number |
CTRI/2026/01/100253 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying if tablet cabergoline, taken before surgery, can lower inflammatory markers in endometriosis. |
|
Scientific Title of Study
|
Effect of preoperative cabergoline therapy on peritoneal fluid inflammatory markers in women undergoing endometriosis surgery, a pilot study |
| Trial Acronym |
CAB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhupinder Deep Kaur |
| Designation |
Fellow Minimally Invasive Gynaecological Surgery |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Obst. and Gynae., Mother and Child Block, AIIMS
South West
DELHI
110029
India |
| Phone |
9463438040 |
| Fax |
|
| Email |
dr.bhupinderdeepkaur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhupinder Deep Kaur |
| Designation |
Fellow Minimally Invasive Gynaecological Surgery |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Obst. and Gynae., Mother and Child Block, AIIMS
South West
DELHI
110029
India |
| Phone |
9463438040 |
| Fax |
|
| Email |
dr.bhupinderdeepkaur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhupinder Deep Kaur |
| Designation |
Fellow Minimally Invasive Gynaecological Surgery |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Obst. and Gynae., Mother and Child Block
South West
DELHI
110029
India |
| Phone |
9463438040 |
| Fax |
|
| Email |
dr.bhupinderdeepkaur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of obstetrics and gynaecology, AIIMS, New delhi, pincode 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS new delhi |
| Address |
Department of obstetrics and gynaecology, mother and child block, AIIMS , Ansari Nagar, new delhi, pin 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bhupinder Deep Kaur |
AIIMS, New delhi |
OPD Room 3, Department of obstetrics and gynaecology , mother and child block, AIIMS, Ansari nagar, pin 110029
New Delhi
DELHI |
9463438040
dr.bhupinderdeepkaur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N809||Endometriosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endometriosis group with Tab Cabergoline. |
Tab Cabergoline 0.5mg twice a week for 4 months |
| Comparator Agent |
Endometriosis group without intervention |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Women aged 18–40 years.
2. Diagnosed with endometriosis
3. Scheduled for elective endometriosis surgery.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
1. At Enrollment
2. Pre-operative(after 4months of intervention drug)
3. Intraoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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. |
Intra-operative |
For Hematological Comparison:
Mean difference in hs-CRP
Mean difference in S. Ferritin
Mean difference in CA-125
|
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. |
Intraoperative |
For Ovarian Reserve Impact:
The absolute change in serum Anti-Müllerian Hormone (AMH) level (ng/mL) from baseline to 4 month preoperative |
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) |
Intraoperative |
For Symptom Response:
The absolute change in patient-reported pelvic pain VAS score (0-10) from baseline to the day of surgery. |
Enrollment
Preoperative (after 4month of intervention) |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
13/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |