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Recruiting NCT05775211

Effects of Intrauterine Administration of Autologous PBMC Modulated With IFNt on Endometrial Cell Populations

Trial Parameters

Condition Infertility
Sponsor Nadezhda Women's Health Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 300
Sex FEMALE
Min Age 18 Years
Max Age 50 Years
Start Date 2023-03-13
Completion 2026-03-14
Interventions
Intrauterine administration of PBMC immunomodulated with IFNt

Brief Summary

The aim of this clinical trial is to investigate the change in endometrial composition during the window of implantation following intrauterine administration of PBMC immunomodulated with IFNt. Patients seeking assisted reproductive therapy will be invited to participate. Two endometrial biopsies will be obtained from each patient during mid-secretory phase of two consecutive menstrual cycles. The first biopsy will be obtained one month before the intervention, and the second one - a day after intrauterine administration of the tested cell treatment which will take place the following month. Immunohistochemistry analysis of the cell composition of the endometrium will be performed.

Eligibility Criteria

Inclusion Criteria: * Participating in Assisted Reproduction Treatment * Having primary infertility * Having regular menstrual cycles * Having signed informed consent Exclusion Criteria: * Uterine pathologies * Endometrial bacterial infections * Active endometrial inflammation * Polycystic ovary syndrome * Presence of auto antibodies such as anti-TPO (thyroid peroxidase), anti-TG (thyroglobulin), ACA (anticentromere antibodies), APA (antiphospholipid antibodies), ANA (antinuclear antibodies), and anti-dsDNA * Presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S * Oncological condition * Positive HIV (human immunodeficiency virus), HCV (hepatitis C virus) or HBV (hepatitis B virus) tests

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