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Effects of Intrauterine Administration of Autologous PBMC Modulated With IFNt on Endometrial Cell Populations
Sponsor: Nadezhda Women's Health Hospital
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.
Official title: Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) Modulated With Interferon Tau (IFNt) on Endometrial Cell Populations
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2023-03-13
Completion Date
2026-04-28
Last Updated
2025-05-21
Healthy Volunteers
Yes
Conditions
Interventions
Intrauterine administration of PBMC immunomodulated with IFNt
Standard 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.
Locations (1)
Nadezhda Women's Health Hospital
Sofia, Sofia, Bulgaria