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Completed

NCT Number: NCT06264206

Effect of Immunomodulatory Treatment on IVF (in Vitro Fertilization) Outcomes in Patients With KIR AA Genotype

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.

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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Calla Ivf Center

Oradea, Bihior, 410103, Romania

About this study

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.

The KIR AA group experienced improved pregnancy outcomes compared to those in the same cohort who did not undergo prior immunomodulatory treatment

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Killer-cell immunoglobulin-like receptors (KIRs) testing

Diagnostic Test

patients were tested for KIRs, and based on the divided in the 2 arms. Patient from ARM KIR AA received immunomuodulatorc treatment.

Other names: immunomodulatory treatment for KIR AA

Primary outcomes

  1. the incidence of immune cause of recurrent implantation failure

    Time frame: 3-6 months

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

    Time frame: 3-6 months

Secondary outcomes

  1. comparation between the pregnancy rates in KIR AA group and KIR Bx group

    Time frame: 3-6 months

Sponsors and collaborators

Lead sponsor

Calla IVF Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 16, 2024
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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