| CTRI Number |
CTRI/2025/08/092706 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate efficacy of an immunomodulator thymosin alpha 1 in women with previous IVF failure at rural setup |
|
Scientific Title of Study
|
to evaluate efficacy of an immunomodulator thymosin alpha 1 in women with previous IVF failure A Randomised controlled trial |
| 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 Deepika Dhundi |
| Designation |
infertility fellow |
| Affiliation |
Datta Meghe institute of higher education and research |
| Address |
ground floor ,wardha test tube baby centre ,acharya vinoba bhave rural hospital , datta meghe institute of higher education and research
Datta meghe university of higher education and research ,sawangi meghe , Wardha 442107
Wardha
MAHARASHTRA
445001
India |
| Phone |
7387149509 |
| Fax |
|
| Email |
deepikadhundi51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamlesh Chaudhari |
| Designation |
professor |
| Affiliation |
Datta Meghe institute of higher education and research |
| Address |
department of obstetrics and gynaecology , acharya vinoba bhave rural hospital , datta meghe institute of higher education and research sawangi wardha
Datta meghe university of higher education and research ,sawangi meghe , Wardha 442107
Wardha
MAHARASHTRA
445001
India |
| Phone |
9320568673 |
| Fax |
|
| Email |
dr.kamleshchaudhari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika Dhundi |
| Designation |
infertility fellow |
| Affiliation |
Datta Meghe institute of higher education and research |
| Address |
wardha test tube baby centre , acharya vinoba bhave rural hospital, datta meghe institute of higher education and research sawangi wardha
Datta meghe university of higher education and research ,sawangi meghe , Wardha 442107
Wardha
MAHARASHTRA
445001
India |
| Phone |
7387149509 |
| Fax |
|
| Email |
deepikadhundi51@gmail.com |
|
|
Source of Monetary or Material Support
|
| datta meghe institute of higher education and research , sawangi meghe wardha 442107
maharashtra india |
|
|
Primary Sponsor
|
| Name |
wardha test tube baby centre |
| Address |
acharya vinoba bhave rural hospital ,Datta meghe institute of higher education and research ,sawangi Meghe , wardha |
| 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 Deepti Shrivastava |
Acharya vinoba bhave rural hospital sawangi meghe wardha |
Wardha test tube baby centre Acharya vinoba bhave rural hospital , datta meghe institute of higher education and research , sawangi meghe , Wardha
Wardha
MAHARASHTRA |
8830818640
deepti_shrivastava69@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCHINSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
hormone replacement treatment in patients of IVF |
regular hormone replacement therapy of IVF |
| Intervention |
Immunomodulator in patients with previous IVF failure |
thymosin alpha 1 injection 1.6 mg two injections alternate day subcutaneously in embryo transfer preparation phase of 21 days uptill 48 hours prior to embryo transfer |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
patients of IVF with previous 1 IVF failure with informed consent |
|
| ExclusionCriteria |
| Details |
known systemic autoimmune condition or known chromosomal abnormalities |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate efficacy of thymosin alpha 1 as an add on tretment to basic hormone therapy in frozen embryo transfer patients |
positive pregnancy outcome with urine pregnancy test at 4 weeks and ultrasonography at 6 weeks for fetal cardiac activity will be evaluated |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate changes in clinical pregnancy rates following thymosin alpha 1 administration |
to check urine pregnacy positivity & ultrasonography at 6 weeks for clinical pregnancy positive rate with thymosin alpha 1 injections |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [deepikadhundi51@gmail.com].
- For how long will this data be available start date provided 02-03-2026 and end date provided 02-03-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A randomised controlled trial will be conducted to evaluate efficacy of immunomodulator thymosin alpha1 in patients with more than 1 previous IVF failure patients at wardha test tube baby centre at acharya vinoba bhave rural hospital ,datta meghe institute of higher education and research with inclusion criteria of patients giving informed consent to enroll in study aged 25 to 45 years old with history of more than1 previous IVF failure and exclusion criteria will be patients with other systemic autoimmune disorders or any chromosomal abnormality |