| CTRI Number |
CTRI/2025/08/092870 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Custom embryo transfer after doing tests in to improve IVF outcome |
|
Scientific Title of Study
|
Personalized Embryo transfer(ET) after combination of available modalities CD138,Preimplantation Genetic Diseases (PGD),Endometrial Receptivity Array (ERA)to improve in-vitro fertilization(IVF) success. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
H s Deeksha |
| Designation |
MS OBGY |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY , IVF LAB , ROOOM 1 .DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, JAWAHARLAL NEHRU MEDICAL COLLEGE,SAWANGI MEGHE,WARDHA
AVBRH Hospital,Wardha test tube baby centre ,sawangi meghe,wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7204976562 |
| Fax |
|
| Email |
deekshaaradhya19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamlesh Choudhry |
| Designation |
Professor, Obgy department |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, JAWAHARLAL NEHRU MEDICAL COLLEGE,SAWANGI MEGHE,WARDHA
AVBRH Hospital ,Wardha test tube baby centre, Sawangi Meghe.
MAHARASHTRA
442001
India |
| Phone |
932568673 |
| Fax |
|
| Email |
dr.kamleshchaudhari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
H s Deeksha |
| Designation |
MS OBGY |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, JAWAHARLAL NEHRU MEDICAL COLLEGE,SAWANGI MEGHE,WARDHA
Department of ob stetrics and gynaecology ,Room no-1 .
MAHARASHTRA
442001
India |
| Phone |
7204976562 |
| Fax |
|
| Email |
deekshaaradhya19@gmail.com |
|
|
Source of Monetary or Material Support
|
| AVBRH Hospital, Datta meghe institute of health education and research ,Sawange,wardha |
|
|
Primary Sponsor
|
| Name |
Individual |
| Address |
AVBRH ,Datta meghe institute of medical education and resarch ,sawangi meghe, wardha |
| Type of Sponsor |
Research institution and hospital |
|
|
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 H s Deeksha |
AVBRH Hospital,Wardha |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, JAWAHARLAL NEHRU MEDICAL COLLEGE,Department of Obstetrics and gynaecology,Room no-1 ,SAWANGI MEGHE,WARDHA
Wardha
MAHARASHTRA |
07204976562
deekshaaradhya19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher education and ReaseachInstitutional 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 |
| Comparator Agent |
Patients with conventional IVF |
Patients with conventional IVf [who have not undergone any other extra tests like my cases] |
| Intervention |
Pregentic testing on the Embryos and ERA and CD138 testing |
Pregentic testing is done on Blastocyst of mebryos and asses the aneuploidy and Endometrial sample is taken to Assess the receptivity assay ,Cd 138 sample is sent |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
female aged 21 to 50 years.
women with subfertility
history of implantation failure,recurrent miscarriage.
those willing to get enrolled in vitro fertilization and give consent for the study |
|
| ExclusionCriteria |
| Details |
Male factor subfertility
Age over 50
poor ovarian reserve
severe endometrial abnormalities like polyp,fibroids.
known genetic disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| combining CD138,Pregenetic diagnosis, Endometrial receptivity array in personalized embryo transfer will improve the outcome |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Personalized embryo transfer (ET)
is a modern approach in in-vitro fertilization (IVF) that seeks to improve the
chances of successful pregnancy by tailoring the treatment to the patient’s
unique genetic and uterine profile. Preimplantation genetic testing
(PGT) is a diagnostic procedure that examines embryos in their early
development, allowing for the selection and transfer of healthy embryos into
the maternal uterus, which reduces the risk of genetic disorders and enhances
the chances of a successful pregnancy. Endometrial Receptivity Array (ERA)
is a diagnostic test that evaluates the molecular profile of the endometrium
(uterine lining) to determine the optimal window for embryo implantation,
helping to identify the most favorable timing for embryo transfer and improve the chances of a successful
pregnancy in IVF treatments .CD138, or syndecan-1, is a cell
surface protein involved in cell adhesion, migration, and signaling, and is used in reproductive
medicine as a marker for assessing endometrial receptivity, crucial for
successful embryo implantation during IVF. Its expression in the endometrium
helps determine if the uterine lining is properly prepared for embryo attachment,
impacting embryo transfer success .This
study aims to explore the benefits and feasibility of combining these
technologies, CD138, and PGD, and to improve embryo selection, optimize
endometrial receptivity, and ultimately enhance pregnancy success rates.
|