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ID05421364

Study on How Intrauterine Autologous PBMC Treatment Affects Endometrial Cell Populations and IVF Success in Women with Infertility

Led by Nadezhda Women's Health Hospital · Updated on 2025-05-21

300

Participants Needed

2

Research Sites

48 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the effects of intrauterine administration of autologous peripheral blood mononuclear cells PBMC on the populations of cells in the endometrium, particularly immune cells, stem cells, and senescent cells. The study focuses on women experiencing female infertility who are undergoing assisted reproduction treatment and have an altered endometrial immune profile. The goal is to understand how PBMC treatment might improve implantation and ongoing pregnancy success in IVF. Participants will receive PBMC treatment where blood is drawn at the time of the LH peak, and PBMCs are isolated, cultured with hHCG, and combined with fresh PBMCs. This cell mixture is then introduced into the uterine cavity on day 2 after the LH peak. The study compares the endometrial cell composition before and one month after the PBMC administration to observe any changes. During the study, participants will have endometrial biopsies taken before and one month after PBMC treatment to assess changes in immune, stem, and senescent cell numbers and distances within the endometrial stroma. IVF outcomes such as embryo implantation rates will be measured two weeks after embryo transfer, and clinical pregnancy rates will be evaluated at six to eight weeks of gestation. The study monitors these outcomes to evaluate the potential impact of PBMC administration on IVF success over the study period.

CONDITIONS

Brief Title

Effects of Intrauterine Administration of Autologous PBMC on the Endometrial Cells Populations

Research Team

G

Georgi Stamenov, MD

R

Rumiana Ganeva, MSc

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