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临床试验/CTRI/2024/11/076768
CTRI/2024/11/076768尚未招募4 期

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

DrGokul Raman1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2024年11月23日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
39
试验地点
1
主要终点
To evaluate the efficacy of LIT in improving ongoing Pregnancy rates (12 weeks) in women with unexplained RPL and RIF.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

To evaluate the efficacy of LIT in improving ongoing Pregnancy rates (12 weeks) in women with unexplained RPL and RIF.

时间窗: 12 weeks

次要结局

  • To investigate the HLA , CDC cross match , Immuno profiling as pre-indications of LIT(To evaluate changes in immune profiling following LIT.)

研究者

发起方
DrGokul Raman
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

DrGokul

A4 Hospital and Fertility centre

研究点 (1)

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