| CTRI Number |
CTRI/2025/12/099138 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
14/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Link between MUSA signs of adenomyosis and patient symptoms |
|
Scientific Title of Study
|
Correlation of MUSA criteria of adenomyosis with clinical characteristics |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Palak Gupta |
| Designation |
Junior Resident |
| Affiliation |
MAHE |
| Address |
Department of Obstetrics and Gynecology
Kasturba Medical College
MAHE
Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9760671919 |
| Fax |
|
| Email |
palakgpt02.pg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyamala G |
| Designation |
Professor and Head of the department |
| Affiliation |
MAHE |
| Address |
Department of Obstetrics and Gynecology
Kasturba Medical College
MAHE
Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9844551037 |
| Fax |
|
| Email |
Shyamala.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Palak Gupta |
| Designation |
Junior Resident |
| Affiliation |
MAHE |
| Address |
Department of Obstetrics and Gynecology
Kasturba Medical College
MAHE
Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9760671919 |
| Fax |
|
| Email |
palakgpt02.pg@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
MAHE
Manipal
Udupi
Karnataka
576104 |
| Type of Sponsor |
Private 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 |
| Palak gupta |
Kasturba Medical College and Hospital |
Department of Obstetrics and Gynecology
Kasturba Medical College
MAHE
Manipal
Udupi
KARNATAKA |
9760671919
palakgpt02.pg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 18 to 55 years undergoing Transvaginal/ Transabdominal sonography for clinical features of adenomyosis and diagnosed with adenomyosis on scan |
|
| ExclusionCriteria |
| Details |
Women with uterine fibroids, uterine anomalies, or postmenopausal status. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Identification of specific Ultrasound markers strongly associated with clinical symptoms
-Improved diagnostic accuracy for adenomyosis using sonographic assessment
-Better patient stratification for management based on sonographic severity |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improved diagnostic accuracy for adenomyosis using sonographic assessment
-Better patient stratification for management based on sonographic severity |
1 day |
|
|
Target Sample Size
|
Total Sample Size="182"
Sample Size from India="182"
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)
|
29/12/2025 |
| 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="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 prospective observational study will be conducted in the Department of Obstetrics and Gynecology, Kasturba Hospital, Manipal. Women of reproductive age presenting with symptoms suggestive of adenomyosis (e.g., dysmenorrhea, menorrhagia, pelvic pain, or infertility) will be recruited after obtaining written informed consent. Participants will undergo a thorough clinical evaluation, including menstrual and obstetric history, symptom severity assessment using VAS and PBAC, and general and pelvic examination. Transvaginal ultrasound (TVUS) will then be performed using MUSA criteria. This includes assessment of direct features (myometrial cysts, hyperechoic islands, echogenic subendometrial lines or buds) and indirect features (asymmetrical myometrial thickening, globular uterus, fan-shaped shadowing, translesional vascularity, irregular junctional zone). All findings will be documented and correlated with clinical symptoms to assess the relationship between ultrasound features and symptom severity. Data will be collected using a standardized format and analyzed using appropriate statistical tools. Ethical approval will be obtained, and confidentiality will be strictly maintained. |