| CTRI Number |
CTRI/2024/10/075117 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
An ultrasound based scoring system to assess the success in patients
of Frozen Embryo Transfer cycles |
|
Scientific Title of Study
|
An ultrasound based uterine scoring system to assess the success in patients
undergoing Frozen Embryo Transfer cycles |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ayushi Agarwal |
| Designation |
MCh senior resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Reproductive Medicine and Surgery Kasturba Medical College Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9455273959 |
| Fax |
|
| Email |
ayushibrettlee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anjali Suneel |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Reproductive Medicine and Surgery Kasturba Medical College Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9455273959 |
| Fax |
|
| Email |
anjali.suneel@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayushi Agarwal |
| Designation |
MCh senior resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Reproductive Medicine and Surgery Kasturba Medical College Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9455273959 |
| Fax |
|
| Email |
ayushibrettlee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Manipal, Karnataka, India. pin code- 576104 |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 AYUSHI AGARWAL |
KASTURBA MEDICAL COLLEGE MANIPAL |
Department of Reproductive Medicine and Surgery, Kasturba Medical College, Manipal
Udupi
KARNATAKA |
9455273959
ayushibrettlee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound |
ultrasound to be performed on the day of embryo transfer to check for endometrial volume, thickness, morphology, blood flow and peristalsis |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing frozen embryo transfer cycles
Age 21-50 years |
|
| ExclusionCriteria |
| Details |
1.Patients with congenital uterine anomalies
2. Patients with acquired uterine pathologies like polyp, submucous myoma, intra uterine adhesions |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical Pregnancy rate |
6 weeks after embryo transfer |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Embryological outcome |
6 weeks after embryo transfer |
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
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)
|
20/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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
|
To analyze the association of various ultrasound parameters like endometrial thickness, echogenicity of central layer of endometrium, endometrial volume, peristalsis, endometrial blood flow and uterine artery doppler flow (PI), with clinical pregnancy rates in the frozen-thawed embryo transfer cycle To formulate an ultrasound based scoring system to assess the endometrial receptivity by evaluating the above |