| CTRI Number |
CTRI/2025/07/091162 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on clinical features , hormonal levels and genetic causes in individuals with atypical genitalia |
|
Scientific Title of Study
|
Clinical,Biochemical,genetic profile and gender identity pattern in Disorders of sex development |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aravind kumar |
| Designation |
Post Graduate in DM Endocrinology |
| Affiliation |
Madurai Medical college |
| Address |
9,Machendra bhavanam, Maruthupandiar 1st street, Pasumpon nagar,Palanganatham,Madurai
Madurai
TAMIL NADU
625003
India |
| Phone |
09384337260 |
| Fax |
|
| Email |
aravindkumar1175@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.S.SRIDHAR |
| Designation |
Professor and HOD ,Department of Endocrinology |
| Affiliation |
Madurai Medical college |
| Address |
Department of Endocrinology,Madurai Medical College and Government Rajaji Hospital,Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
9789720246 |
| Fax |
|
| Email |
drsridharjipmer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aravind kumar |
| Designation |
Post Graduate in DM Endocrinology |
| Affiliation |
Madurai Medical college |
| Address |
9,Machendra bhavanam, Maruthupandiar 1st street, Pasumpon nagar,Palanganatham,Madurai
Madurai
TAMIL NADU
625003
India |
| Phone |
09384337260 |
| Fax |
|
| Email |
aravindkumar1175@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Endocrinology,Madurai Medical College,Government Rajaji Hospital,Madurai -625020 |
|
|
Primary Sponsor
|
| Name |
Department Of Endocrinology |
| Address |
Madurai Medical College,MADURAI,TAMILNADU,India-625020 |
| Type of Sponsor |
Government medical college |
|
|
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 Aravind kumar |
DEPARTMENT OF ENDOCRINOLOGY,GOVERNMENT RAJAJI HOSPITAL MADURAI.OP NO -18 |
Panagal road,Gorpalayam,Madurai-625002
Madurai
TAMIL NADU |
09384337260
aravindkumar1175@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,MADURAI MEDICAL COLLEGE,MADURAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E349||Endocrine disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
46 XX and 46 XY DSD with genital ambiguity,proximal or midshaft hypospadias,Apparent female genitalia with clitoromegaly,Female phenotype with primary amenorrhoea,Children with inguinal or labial mass,Posterior labial fusion and common urogenital sinus |
|
| ExclusionCriteria |
| Details |
Sex chromosomal DSD like Turner syndrome and Klinefelter syndrome.
Ambiguous genitalia due to maternal androgen exposure ,maternal virilizing ovarian or adrenal tumour |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify proportion of patients in whom a pathogenic or likely pathogennic variant is idenitfied explaining the DSD phenotype |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find any discrepancy in assigned gender at birth & gender identity pattern in adolescense
|
Baseline |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
28/07/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
To study clinical and biochemical parameters in patients with Disorders of sex development and correlate them with genetic analysis and find discrepancies if any.This could help in more accurate diagnosis and gender assignment . Early appropriate diagnosis would aid in future therapies and genetic counselling . |