| CTRI Number |
CTRI/2024/05/066913 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the effect of endometrioma on ovarian reserve |
|
Scientific Title of Study
|
Comparison of serum anti müllerian hormone (AMH)levels as a marker of ovarian reserve in reproductive age women with and without endometrioma - A Cross-sectional analytical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijithaa M P |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry |
| Address |
Department of Obstetrics and Gynaecology
JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9659626257 |
| Fax |
|
| Email |
mpvijithaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujatha V |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry |
| Address |
Department of Obstetrics and Gynaecology
JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7598500890 |
| Fax |
|
| Email |
drsujatharaman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujatha V |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry |
| Address |
Department of Obstetrics and Gynaecology
JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7598500890 |
| Fax |
|
| Email |
drsujatharaman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural research funds, Jawaharlal Institute of Postgraduate Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
JIPMER campus road,Gorimedu,Dhanvantri Nagar, Puducherry 605006 |
| 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 |
| Dr Vijithaa M P |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of Obstetrics and Gynaecology, WCH,JIPMER campus road, Gorimedu,Dhanvantri Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY |
9659626257
mpvijithaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Observational studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N801||Endometriosis of ovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Female |
| Details |
Women between 18-39 years of age
Women with regular menstrual cycles |
|
| ExclusionCriteria |
| Details |
Known case of endometrima underwent cystectomy or surgeries
Women diagnosed with pcos
Women underwent chemotherapy or radiotherapy
Women on hormonal therapy irrespective of indications |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare serum AMH levels between patients with and without endometrioma |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation between size of endometrioma and AMH levels
Correlation between USG pattern of endometrioma and AMH levels |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="192"
Sample Size from India="192"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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
|
Following PGRMC, Institutional ethics committee approval, subjects are being recruited. Detailed history regarding medical, obstetric, treatment history are noted. Detailed Gynaecological examination is done. Subjected to ultrasound examination to look for presence of endometrioma. If found it’s number,size, location, vascularity are noted.serum AMH levels are also estimated and will be compared with age matched patients without ovarian endometriosis |