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CTRI Number  CTRI/2025/12/099381 [Registered on: 18/12/2025] Trial Registered Prospectively
Last Modified On: 18/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective cohort study 
Study Design  Single Arm Study 
Public Title of Study   Comparing Three Ultrasound Methods to Predict Pregnancy Success After Embryo Transfer 
Scientific Title of Study   Comparative evaluation of Applebaum score, Modified Applebaum score and external layer thickness (ELT) for predicting clinical pregnancy after embryo transfer: a prospective cohort 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  DrThamaraiselvi  
Designation  Fellowship Doctor  
Affiliation  A4 Hospitals and Fertility centre Pvt Ltd  
Address  Room no: 2 31, Grand Southern Trunk Rd, West Tambaram, Irumbuliyur, Chennai, Tamil Nadu

Chennai
TAMIL NADU
600045
India 
Phone  9443638493  
Fax    
Email  thamaraikirubakaran@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrThamaraiselvi  
Designation  Consultant  
Affiliation  A4 Hospitals and Fertility centre Pvt Ltd  
Address  Room no: 2 31, Grand Southern Trunk Rd, West Tambaram, Irumbuliyur, Chennai, Tamil Nadu


TAMIL NADU
600045
India 
Phone  9443638493  
Fax    
Email  thamaraikirubakaran@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrThamaraiselvi  
Designation  Fellowship Doctor  
Affiliation  A4 Hospitals and Fertility centre Pvt Ltd  
Address  Room no: 2 31, Grand Southern Trunk Rd, West Tambaram, Irumbuliyur, Chennai, Tamil Nadu


TAMIL NADU
600045
India 
Phone  9443638493  
Fax    
Email  thamaraikirubakaran@gmail.com  
 
Source of Monetary or Material Support  
A4 Hospitals and Fertility centre Pvt Ld,Chennai, 600092 
 
Primary Sponsor  
Name  DrThamaraiselvi  
Address  31, Grand Southern Trunk Rd, West Tambaram, Irumbuliyur, Chennai, Tamil Nadu 600045 
Type of Sponsor  Private hospital/clinic 
 
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 
DrThamaraiselvi  A4 Hospital and Fertility centre Pvt Ltd  Room no: 2 31, Grand Southern Trunk Rd, West Tambaram, Irumbuliyur, Chennai, Tamil Nadu
Chennai
TAMIL NADU 
09443638493

thamaraikirubakaran@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
A4 Hospital - instituitional ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N972||Female infertility of uterine origin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  42.00 Year(s)
Gender  Female 
Details  Women undergoing embryo transfer in ICSI cycles
BMI from 19 to 35
All protocols
 
 
ExclusionCriteria 
Details  Presence of known intrauterine pathology not corrected before ET, submucosal fibroid, large polyp greater than 1.5cm, unless surgically corrected.
Hydrosalpinx not treated.
Uterine anomalies.
Ashermans with severe scarring
Adenomyosis
Surrogacy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical pregnancy rate   7 weeks of pregnancy  
 
Secondary Outcome  
Outcome  TimePoints 
Biochemical pregnancy rate   14 days  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   31/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/12/2025 
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  

This prospective cohort study aims to compare three ultrasound based methods Applebaum score Modified Applebaum score and External Layer Thickness ELT to determine which best predicts endometrial receptivity and clinical pregnancy after frozen embryo transfer FET

The study evaluates women aged 22 to 42 undergoing single or double embryo transfer with at least one good quality embryo 

Applebaum and Modified Applebaum scores assess multiple endometrial parameters while ELT is a simpler quantitative measure describing the outer hyperechoic layer

Although widely used comparative prospective data on these scoring systems are limited

The primary objective is to identify which scoring system most accurately predicts clinical pregnancy

Secondary analyses include diagnostic accuracy sensitivity specificity positive predictive value negative predictive value association with early pregnancy loss and odds of pregnancy across high and low score groups. Ultrasound assessments are performed on the day of progesterone start and outcomes are measured through beta hCG and clinical pregnancy confirmation

Statistical analysis will involve ROC curve comparison regression models and appropriate inferential tests. Ethical approval informed consent and secure data handling will be ensured

This study may help determine whether a complex score a modified system or a single ELT measurement provides the most reliable tool for clinical decision making and improving FET outcomes.

 
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