About this trial
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
This trial accepts healthy volunteersQualifiers
Participating in Assisted Reproduction Treatment
Having primary infertility
Having regular menstrual cycles
Having signed informed consent
Disqualifiers
Uterine pathologies
Endometrial bacterial infections
Active endometrial inflammation
Polycystic ovary syndrome
Trial design
Single group
Treatments tested in this trial
Intrauterine administration of PBMC immunomodulated with IFNt
Biological/VaccineStandard density gradient centrifugation will be performed to obtain autologous PBMC from patients' peripheral blood (9 ml). Isolated cells will be suspended in RPMI 1640 supplemented with 10% HSA (human serum albumin) and incubated in the presence of 500 IU/ml IFNt for 24 h at 37˚C. The cultured cell suspension will be introduced into the uterine cavity via a catheter.
Treatment groups
Trial outcomes
Primary outcomes
Change in the numbers of certain endometrial cell populations (immune cells, stem cells, senescent cells) from their levels one month prior to intrauterine administration of immunomodulated PBMC
Immunohistochemical analysis of endometrial biopsies
Locations
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Sponsors and contacts
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