NCT06264206

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

February 12, 2024

Last Update Submit

February 12, 2024

Conditions

Immunomodulatory DrugsKiller-cell Immunoglobulin-like Receptors (KIRs)KIR Alleles (KIR AA)

Outcome Measures

Primary Outcomes (2)

  • the incidence of immune cause of recurrent implantation failure

    3-6 months

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

    3-6 months

Secondary Outcomes (1)

  • comparation between the pregnancy rates in KIR AA group and KIR Bx group

    3-6 months

Study Arms (2)

KIR AA

EXPERIMENTAL

Patients from arm KIR AA received immunomodulatory treatment, and the pregnancy rate was calculated after this treatment, and compared to the one before the treatment

Diagnostic Test: Killer-cell immunoglobulin-like receptors (KIRs) testing

KIR BX

NO INTERVENTION

Patients from arm KIR BX did not receive immunomodulatory treatment, and the pregnancy rate was calculated and compared with the ones from arm KIRR AA- before and after immunomodulatory treatment

Interventions

Killer-cell immunoglobulin-like receptors (KIRs) testingDIAGNOSTIC_TEST

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

Also known as: immunomodulatory treatment for KIR AA
KIR AA

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Calla Ivf Center

Oradea, Bihior, 410103, Romania

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 16, 2024

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

RO(1)