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CTRI Number  CTRI/2024/11/076768 [Registered on: 13/11/2024] Trial Registered Prospectively
Last Modified On: 09/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Lymphocyte immunization therapy in patients with recurrent implantation failure. 
Scientific Title of Study   Evaluating the Efficacy of Lymphocyte Immunization Therapy in Improving Ongoing Pregnancy Rates in Women with Recurrent Pregnancy Loss and Implantation Failure: A Prospective Interventional Single Arm Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrGokul 
Designation  Embryologist 
Affiliation  A4 Hospital and Fertility centre 
Address  Embryology Department A4 Fertility centre 87 Arcot road , virugampakkam

Chennai
TAMIL NADU
600092
India 
Phone  09841269578  
Fax    
Email  aruna@a4fertility.com  
 
Details of Contact Person
Scientific Query  
Name  DrGokul 
Designation  Embryologist 
Affiliation  A4 Hospital and Fertility centre 
Address  Embryology Department A4 Fertility centre 87 Arcot road , virugampakkam

Chennai
TAMIL NADU
600092
India 
Phone  09841269578  
Fax    
Email  gokulrams1996@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrGokul 
Designation  Embryologist 
Affiliation  A4 Hospital and Fertility centre 
Address  Embryology Department A4 Fertility centre 87 Arcot road , virugampakkam

Chennai
TAMIL NADU
600092
India 
Phone  09841269578  
Fax    
Email  gokulrams1996@gmail.com  
 
Source of Monetary or Material Support  
A4 Hospital and Fertility centre No 87 Arcot road Virugambakkam Chennai 600092  
 
Primary Sponsor  
Name  DrGokul Raman  
Address  Embryology Department A4 Hospital and Fertility centre No 87 Arcot road Virugambakkam Chennai 600092  
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrGokul  A4 Hospital and Fertility centre  Deaprtment of Embryology A4 Fertility centre 87 Arcot road , virugampakkam
Chennai
TAMIL NADU 		 9159072250

gokulrams1996@gmail.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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N978||Female infertility of other origin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lymphocyte immunization therapy   The isolated lymphocytes are injected intradermally into the female partner, typically in the forearm. The procedure may be repeated at interval of 15 days twice, and usually before conception and possibly during early pregnancy, 3rd dose of LIT.  
Comparator Agent  Not applicable   Not applicable  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Recurrent Pregnancy Loss:
Unexplained Infertility
Repeated Implantation Failure
High HLA match more than 2 alleles between the mother and father, especially HLA-C
Negative CDC cross-match
Negative ANA (antinuclear antibody)

 
 
ExclusionCriteria 
Details  Uncorrected Endocrine disorder
Uncorrected Uterine Anomalies and Thin Endometrium less than 7mm
APLA positivity and Systemic Autoimmune Conditions
Women not willing for Immunological evaluation
Untreated Chronic Endometritis
Transfer of Embryo Grade C or D
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of LIT in improving ongoing Pregnancy rates (12 weeks) in women with unexplained RPL and RIF.
 		 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To investigate the HLA , CDC cross match , Immuno profiling as pre-indications of LIT
To evaluate changes in immune profiling following LIT.
 		 8 weeks  
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
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 4 
Date of First Enrollment (India)   23/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  23/11/2024 
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  


This prospective interventional study evaluates the efficacy of Lymphocyte Immunotherapy (LIT) in enhancing ongoing pregnancy rates in women with unexplained recurrent pregnancy loss (RPL) and recurrent implantation failure (RIF), focusing on immune profile changes, particularly Treg levels and the Th1/Th2 cytokine balance. Inclusion criteria include RPL or RIF with unexplained infertility, high HLA match (≥2 alleles, especially HLA-C), and negative CDC cross-match and ANA, while exclusions cover uncorrected endocrine issues, uterine anomalies, thin endometrium (<7mm), APLA positivity, untreated chronic endometritis, refusal of immunology evaluation, and Grade C/D embryo transfers. Lymphocytes, sourced from paternal or third-party donors, are isolated through density gradient centrifugation. The LIT procedure involves subcutaneous injections in the maternal forearm, typically administered twice preconception and once in early pregnancy, with patients monitored for immediate reactions and followed up regularly to assess immune response and progress.
 
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