| CTRI Number |
CTRI/2023/01/049129 [Registered on: 20/01/2023] Trial Registered Prospectively |
| Last Modified On: |
22/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Influence of secreted factors by gametes on cells of uterus |
|
Scientific Title of Study
|
In vitro modulation of endometrial cells by embryonic secretome using IVF and ICSI derived embryos |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ameya Jijo |
| Designation |
Integrated PhD |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Reproductive Science, Division of Clinical Embryology, Kasturba Medical College, Manipal
Central Research Lab, Near MIS office, Kasturba Medical college, Manipal, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9656772987 |
| Fax |
|
| Email |
ameya.jijo@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satish Kumar Adiga |
| Designation |
HOD and Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Reproductive Science, Division of Clinical Embryology, Kasturba Medical College, Manipal
Central Research Lab, Near MIS office, Kasturba Medical college, Manipal, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945671115 |
| Fax |
|
| Email |
satish.adiga@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satish Kumar Adiga |
| Designation |
HOD and Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Reproductive Science, Division of Clinical Embryology, Kasturba Medical College, Manipal
Central Research Lab, Near MIS office, Kasturba Medical college, Manipal, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945671115 |
| Fax |
|
| Email |
satish.adiga@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Manipal |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education,Manipal |
| Address |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Madhav nagar, Manipal Udupi KARNATAKA |
| 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 |
| Ameya Jijo |
Kasturba Medical College, Manipal |
Room No: 19 Division
of Clinical Embryology,
Department of
Reproductive Science,
Manipal Academy of
Higher Education,
Manipal Udupi
KARNATAKA
Udupi
KARNATAKA
Udupi
KARNATAKA |
9656772987
ameya.jijo@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N399||Disorder of urinary system, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Male: Infertile males with age more than 22 years and less than 50 years
Female: Infertile females with age more than 22
years and less than 35 years
|
|
| ExclusionCriteria |
| Details |
Male: Infertile males with less than 22 years and more than 50 years
Female: Infertile females with less than 22 years and more than 35
years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will help us to understand the influence of embryonic secreted factors on the modulation of endometrial cells. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will help to develop a biomarker to predict the embryo with highest implantation potential from various fertilization techniques |
1 year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/01/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Nation-wide, infertile couples (~20% of married-couples) experience enormous emotional,
socioeconomic and cultural burden due to their childlessness-state and the attached social-stigma
(Freeman et al., 1987; Guerra et al., 1998). To overcome this, they seek ART, as promising
infertility therapy option (other than child adoption). Conservative estimate shows that there are
approximately 385 nationally (ICMR) registered ART centers (~900 un-registered) which
provide paid-services. Unfortunately, the success rates of clinical pregnancy (~25%) and live
births (<15%) have continued to be poor. Among other factors, the loss of biological viability of
cultured 2-4-cell embryos or blastocysts contributes to the substantial post-ET embryonic loss.
Besides, in ART-based pregnancies, obstetrical complications due to doublet/triples are higher
(Alfarawati et al. 2011; Sandalinas et al., 2001). To mitigate these issues, there is an urgent
unmet need to develop new (novel) cost-effective, non-invasive, point-of-care (PoC), molecular
diagnostics to accurately predict potential biological viability and to select such viable-embryos
for ET. The success rate can also improve by selecting competent gametes and enhancing the
implantation process of embryos. |