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CTRI Number  CTRI/2026/02/103456 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 03/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparing health outcomes of a hormone releasing intra uterine device versus surgical removal of uterus for treating abnormal uterine bleeding. 
Scientific Title of Study   Clinical outcomes with levonorgestrel releasing intrauterine system versus laparoscopic hysterectomy in AUB 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shambhavi Singh 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  2,Baker street opposite IVRI gate no.2, Izatnagar, Bareilly.

Bareilly
UTTAR PRADESH
243122
India 
Phone  7619447972  
Fax    
Email  shambhavisingh071998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jyothi Shetty 
Designation  Professor and unit head 4 
Affiliation  Kasturba Medical College, Manipal 
Address  Women and child block Kasturba Hospital, Manipal
Kasturba Hospital
Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  jyothi.shetty@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Jyothi Shetty 
Designation  Professor and unit head 4 
Affiliation  Kasturba Medical College, Manipal 
Address  Women and child block Kasturba Hospital
Kasturba Hospital
Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  jyothi.shetty@manipal.edu  
 
Source of Monetary or Material Support  
Department of obstetrics and Gynecology, Kasturba Medical College, Manipal , Udupi , Karnataka, India. pin code -576104 
 
Primary Sponsor  
Name  KASTURBA MEDICAL COLLEGE MANIPAL 
Address  Department of Obstetrics and gynecology , Women and child block, Kasturba Medical College, Manipal, Udupi, Karnataka , India -576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shambhavi Singh  Kasturba Medical College, Manipal  Department of Obstetrics and gynaecology, Women and child block.
Udupi
KARNATAKA 
7619447972

shambhavisingh071998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  AUB-A (Adenomyosis),P (POLYP), AUB-L (Leiomyoma less than , equal to 16 weeks size) 
 
ExclusionCriteria 
Details  AUB-L (leiomyoma more than 16 weeks size), AUB-C (Coagulopathy), AUB-I (Iatrogenic), AUB-N (Neoplasia), AV malformations 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Efficacy, quality of life, sexual health, emotional health, physical and general health, and psychological health  before procedure, 6 months and 1 year after procedure 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in haemoglobin levels to asess correction of anemia, changes in endometrial thickness (in the LNG-IUS group), patient satisfaction, changes in menstrual patterns, duration of hospital stay, time taken to resume normal activities  before procedure, 6 months and 1 year post procedure 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   16/02/2026 
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="0"
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  

Abnormal uterine bleeding or AUB is a common condition that significantly affects women’s quality of life and is classified using the FIGO PALM COEIN system. Although hysterectomy has traditionally been the definitive treatment, it carries surgical and psychological risks. The levonorgestrel-releasing intrauterine system has emerged as an effective, conservative alternative that reduces menstrual blood loss, improves haemoglobin levels, and enhances quality of life. Multiple studies have shown high satisfaction rates and significant symptom improvement with LNG-IUS. Comparative research indicates that while hysterectomy offers higher satisfaction for some women, LNG-IUS is associated with fewer complications and is cost-effective. Indian studies similarly demonstrate the strong efficacy and acceptability of LNG-IUS. Despite growing evidence supporting both treatments, no standardised guideline exists to guide choice between LNG-IUS and hysterectomy, highlighting the need for further comparative studies to inform clinical decision-making and improve patient counselling.

 
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