| CTRI Number |
CTRI/2024/04/065999 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Pregnancy prediction in IVF cases by Ultrasound |
|
Scientific Title of Study
|
Ultrasound based predictive model for pregnancy prediction in IVF 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 Snehal Naphade |
| Designation |
IVF Fellow |
| Affiliation |
Datta Meghe Institute Of Higher Education |
| Address |
Wardha Test Tube Baby Centre ,
1st Floor, AVBRH Building, DMIHER Campus, Sawangi, Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
9822461725 |
| Fax |
|
| Email |
snehun20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepti Shrivastava |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education |
| Address |
Wardha Test Tube Baby Centre ,
1st Floor, AVBRH Building, DMIHER Campus, Sawangi, Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
8830818640 |
| Fax |
|
| Email |
deepti_shrivastava69@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepti Shrivastava |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education |
| Address |
Wardha Test Tube Baby Centre ,
1st Floor, AVBRH Building, DMIHER Campus, Sawangi, Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
8830818640 |
| Fax |
|
| Email |
deepti_shrivastava69@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education |
| Address |
Sawangi Meghe Wardha, Maharashtra 442004 |
| 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 Snehal Naphade |
Jawaharlal Nehru Medical College |
Wardha Test Tube Baby Centre,
1st Floor, AVBRH campus,Sawangi,
Wardha
Wardha
MAHARASHTRA |
9822461725
snehun20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute Of Higher Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Age less than 35years
AMH more than 1.2 ng/ml
AFC more than 5
BMI less 30kg/m2
Primary infertility
|
|
| ExclusionCriteria |
| Details |
History of myomectomy
Uterine malformation
PCOS patients
Endometriosis
Adenomyosis
History of tuberculosis
Uterine malformation
– P4 level more than 1 on day 10 of cycle.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prediction model for IVF pregnancy occurring after IVF frozen embryo transfer |
Data will be assessed after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
10/07/2024 |
| 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
|
Introduction: . The global prevalence of Infertility is 15% (1). Currently, there are no reliable and consistent conclusions regarding ultrasound assessment of endometrial receptivity and in predicting clinical pregnancy outcomes in IVF- ET(1). Material and Methodology: It will be a prospective observational study which will be conducted in the IVF lab of Wardha Test Tube Baby Centre. 45 patients undergoing frozen embryo transfer will be studied over a period of 6 months. We will measure the parameters like endometrial thickness, pattern, peristalsis, myometrial echogenicity, uterine artery blood flow, endometrial and myometrial blood flow and endometrial volume on the day of embryo transfer. Beta hCG will be done on day 14 of embryo transfer and confirmation of cardiac activity will be done at 7 weeks of gestation by ultrasonography. To establish a prediction model, total score method and logistic regression analysis methods will be used. |