Effect of Intrauterine Administration of Autologous PBMC Modulated With IFNt on IVF Outcome
Infertility, Female, IVF
About this trial
This is an interventional treatment trial for Infertility, Female focused on measuring intrauterine PBMC, interferon tau, implantation, clinical pregnancy, live birth rate
Eligibility Criteria
Inclusion Criteria: Participating in Assisted Reproduction Treatment Having primary infertility Having regular menstrual cycles Scheduled to undergo embryo transfer of euploid embryos only 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
Sites / Locations
- Nadezhda Women's Health HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intrauterine administration of PBMC immunomodulated with IFNt
Control Group
Approximately 9 ml whole blood will be collected from each patient 5 days post LH peak by peripheral venipuncture using a 21G butterfly catheter affixed via vacutainer to negative pressure receiving tubes (BD vacutainer acid-citrate-dextrose (ACD-A), REF:366645). PBMC will be isolated by density gradient centrifugation in room-temperature centrifuge set to 400 g for 25 min. After washing the obtained PBMCs, they 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. On day 6 after LH peak, this cultured cell suspension will be carefully introduced in the uterine cavity by catheter. The following day (LH+7), patients will undergo a standard embryo transfer (ET) procedure.
Participants will undergo standard embryo transfer procedure with no intervention.