| 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
|
|
|
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
|
|
|
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. |