| CTRI Number |
CTRI/2025/02/080835 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Thymosin in Patient with Recurrent miscarriages |
|
Scientific Title of Study
|
An Interventional pilot study to assess the efficacy of Thymosin therapy in patients with recurrent pregnancy loss with immune dysregulation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aruna R |
| Designation |
Clinical Director and Senior Fertility consultant |
| Affiliation |
A4 Hospital and Fertility centre |
| Address |
Room no : 3
Deparment of Reproductive medicine
A4 Hospital and Fertility centre,
Virugambakkam
Chennai
Chennai
TAMIL NADU
600092
India |
| Phone |
09841269578 |
| Fax |
|
| Email |
aruna@a4fertility.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aruna R |
| Designation |
Clinical Director and Senior Fertility consultant |
| Affiliation |
A4 Hospital and Fertility centre |
| Address |
Room no : 3
Department of reproductive medicine
A4 Hospital and Fertility centre,
Virugambakkam
Chennai
Chennai
TAMIL NADU
600092
India |
| Phone |
09841269578 |
| Fax |
|
| Email |
aruna@a4fertility.com |
|
Details of Contact Person
Public Query
|
| Name |
Aruna R |
| Designation |
Clinical Director and Senior Fertility consultant |
| Affiliation |
A4 Hospital and Fertility centre |
| Address |
oom no : 3
Deparment of Reproductive medicine
A4 Hospital and Fertility centre,
Virugambakkam
Chennai
Chennai
TAMIL NADU
600092
India |
| Phone |
09841269578 |
| Fax |
|
| Email |
aruna@a4fertility.com |
|
|
Source of Monetary or Material Support
|
| A4 Hospital and Fertility centre
Virugambakkam , Chennai 600092 |
|
|
Primary Sponsor
|
| Name |
Aruna R |
| Address |
A4 Hospital and Fertility centre Virugambakkam Chennai 600092 |
| Type of Sponsor |
Other [Aruna R] |
|
|
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 |
| Aruna R |
A4 Hospital and Fertility centre |
A4 Hospital and Fertility centre,
Department of Reproductive medicine
87 Arcot road , virugambakkam
Chennai
TAMIL NADU |
09841269578
aruna@a4fertility.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A4 Hospital - instituitional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N96||Recurrent pregnancy loss, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Thymosin α1 injection is given for patient with recurrent pregnancy loss with immune dysregulation |
From D1 of HRT, Two subcutaneous (1.6 mg x 2 ) injections every alternative day until ET is achieved, one injection 48 hours before ET |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
History of recurrent pregnancy loss and abnormal immunoprofiling.
|
|
| ExclusionCriteria |
| Details |
Female Participant having any endometrial disorder
Known immunological diseases like Psoriasis,SLE, and RA etc.
Known case of congenital/acquired thrombophilia.
Uncorrected septate uterus, myoma and adenomyoma
Thin endometrium less than 7mm despite measures to improve
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ongoing Pregnancy rate |
12 Weeks of pregnancy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical pregnancy rate |
6 weeks of gestation |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/02/2025 |
| Date of Study Completion (India) |
21/05/2025 |
| Date of First Enrollment (Global) |
26/02/2025 |
| Date of Study Completion (Global) |
21/05/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Thymosin α1is a potential treatment that can be dosed in combination with standard of care in patients with RPL. The aim of administration of Thymosin α1 in RPL patients is to evaluate the Efficacy and safety of Thymosin α1 as an add-on therapy to standard of care (SOC) in Patients with Recurrent Pregnancy Loss (RPL) with altered immunoprofile.Interventional pilot study. After the diagnosis of Recurrent Pregnancy Loss (RPL), patients undergo immunoprofiling. In this process, the ratio of Th1 to Th2 cytokines is measured. If the ratio is low, indicating higher TNF-alpha and lower IL-10 levels, it suggests a disturbance in immune tolerance. Based on this ratio, the grading of immune dysregulation is performed. The efficiency of thymosin therapy in improving Assisted Reproductive Technology (ART) outcomes is then assessed and compared across mild, moderate, and severe dysregulation levels. |