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临床试验/NCT06264206
NCT06264206已完成不适用

Effect of Immunomodulatory Treatment on IVF Outcomes in Patients With KIRR AA Genotype: a Retrospective Cohort Study With Implications for Personalized Fertility Strategies

Calla IVF Center2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
2
主要终点
the efficiency of immnomodulatory treatment on pregnancy rate in patients with KIR AA

研究概览

简要总结

The aim of the study is to investigate the immune cause of recurrent implantation failure (RIF) and the role of immunomodulatory treatment in IVF (in vitro fertilization) patients that have a KIR AA genotype. We compared pregnancy rates in Group KIR AA without immunomodulatory treatment, and pregnancy rates in Group KIR AA with immunomodulatory treatment.

详细描述

The investigators included patients that underwent an (IVF )in vitro fertilization procedure in CALLA IVF Clinic Oradea - Romania, between 01 January 2022 and 31 December 2023.

Recurrent implantation failure (RIF) impacts 10% of couples undergoing in vitro fertilization (IVF), prompting the exploration of tailored treatments to address underlying causes and enhance implantation rates. Among these causes, maternal immune tolerance toward embryos has garnered significant attention in RIF research, with Killer-cell immunoglobulin-like receptors (KIRs) on natural killer (NK) cells emerging as key players in maternal-fetal immune interactions. The investigation into KIR alleles (KIR AA) in RIF is rooted in the theory that specific KIR-HLA-C combinations may contribute to implantation failures. Recent studies suggest that KIR genotyping could serve as a predictive tool for RIF, potentially enabling personalized approaches in assisted reproductive technology, such as immunomodulatory treatments and tailored embryo transfers.

All couples underwent IVF ovarian stimulation, with various factors documented including age, type of infertility, number of oocytes retrieved, number of embryos produced, pregnancy rate.

A total of 65 patients were enrolled in this study, with 24 patients included in group A, this is the group with KIR AA and 41 patients included in the group B, meaning the group with the KIR Bx Inclusion criteria: patients with an infertility diagnosis having an IVF procedure with at least two top-quality embryo to transfer (according to Gardners criteria), that sign the accord to be enrolled in this study with a negative test for chronic endometritis and normal hysteroscopic findings, also patients that have an history of recurrent pregnancy loss and have an IVF indication will be tested in the first round.

Exclusion criteria: absence of signed consent, refusal of hysteroscopy, uterine abnormalities, thin endometrium, endometrial polyps, pelvic cancer, acute inflammatory disease, Asherman syndrome, chronic endometritis, oocyte or spermatozoa donor.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patients with an infertility diagnosis having an IVF procedure with at least two top-quality embryo to transfer (according to Gardners criteria)
  • patients that sign the accord to be enrolled in this study
  • patients with a negative test for chronic endometritis and normal hysteroscopic findings,
  • patients that have an history of recurrent pregnancy loss and have an IVF indication will be tested in the first round.

排除标准

  • absence of signed consent
  • refusal of hysteroscopy
  • uterine abnormalities
  • thin endometrium
  • endometrial polyps
  • pelvic cancer
  • acute inflammatory disease
  • Asherman syndrome
  • chronic endometritis

结局指标

主要结局

the efficiency of immnomodulatory treatment on pregnancy rate in patients with KIR AA

时间窗: 3-6 months

the incidence of immune cause of recurrent implantation failure

时间窗: 3-6 months

次要结局

  • comparation between the pregnancy rates in KIR AA group and KIR Bx group(3-6 months)

研究者

发起方
Calla IVF Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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