| 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
|
|
|
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
|
|
|
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. |