| CTRI Number |
CTRI/2024/03/063714 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Cabergoline as an Adjunct to Ovulation Induction in Infertile Women with Endometriosis |
|
Scientific Title of Study
|
Cabergoline as an Adjunct to Ovulation Induction in Infertile Women with Endometriosis: An Open-label Randomized Study |
| Trial Acronym |
ENDOCAB001 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Garima Kachhawa |
| Designation |
PROFESSOR |
| Affiliation |
AIIMS |
| Address |
Room 701, 7th Floor, Mother and Child Block, Gate 6B, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868246702 |
| Fax |
911126588641 |
| Email |
garimakachhawa2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Garima Kachhawa |
| Designation |
PROFESSOR |
| Affiliation |
AIIMS |
| Address |
Room 701, 7th Floor, Mother and Child Block, Gate 6B, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868246702 |
| Fax |
911126588641 |
| Email |
garimakachhawa2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krutika Dave |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
706, 7th Floor, Hostel 19 (Patanjali), AIIMS, NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9974326920 |
| Fax |
|
| Email |
krutikadave1512@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Ansari Nagar, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Dr Garima Kachhawa |
AIIMS, NEW DELHI |
Room number - 701, 7th Floor, Department of Obstetrics and Gynaecology, Mother and Child Block, AIIMS, Ansari Nagar, New Delhi
New Delhi
DELHI |
9868246702
garimakachhawa2012@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 |
| Comparator Agent |
Letrozole |
5mg Once a day for 5 Days |
| Intervention |
Tablet Cabergoline with Tablet Letrozole |
Tab. Cabergoline (0.5 MG) 1 Tablet Twice a week with Tab. Letrozole (5 MG) Once a day for 5 Days |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
Infertile women with clinically diagnosed endometriosis, with patent tubes, AMH level more than 1.5, AFC count more than 6, husband semen analysis within normal limits |
|
| ExclusionCriteria |
| Details |
BMI more than 35, compromised tubal function or bilateral tubal block, moderate to severe male factor infertility, grade 3,4 endometriosis, chronic inflammatory disorders, history of allergy to any study drugs, patients with decreased ovarian reserve |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ovulation rate |
1, 2, 3, 4 cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cummulative pregnancy rate |
4 months |
| endometrial thickness |
1,2,3,4 |
| pretreatment im]nflammatory markers with ovulation and pregnancy rate |
1,4 |
| incidence of dysmenorrhea and dyspareunia by visual analog scale |
1,2,3,4 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/03/2024 |
| 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
|
Endometriosis is a chronic inflammatory disease associated with infertility in upto 50% patients. The standard therapy for these patients is ovulation induction, which has success rate of around 50%. Cabergoline is antiangiogenic drug used to improve ovulation in women with hyperprolactinoma and PCOS. IT also reduces the level of inflammatory markers in peritoneum. therefore, our proposed approach involves utilizing cabergoline as an adjunct to ovulation induction plus intrauterine insemination cycles for infertility in endometriosis patients. This strategy aims to reduce peritoneal inflammation and progression of endometriosis without adversely affecting ovulation. |