Actively Recruiting
Effects of Intrauterine Administration of Autologous PBMC on the Endometrial Cells Populations
Led by Nadezhda Women's Health Hospital · Updated on 2025-05-21
300
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
Sponsors
N
Nadezhda Women's Health Hospital
Lead Sponsor
M
Medical diagnostic laboratory ImunoVita
Collaborating Sponsor
AI-Summary
What this Trial Is About
The behaviour of the endometrium during its receptive phase is highly dependent on the endometrial cell type composition. Each cell type has its role in the endometrial preparation for the invading embryo. Alteration in the immune cells dialogue could be the main reason for unsuccessful implantation in certain patients. Immune cell homeostasis is often improved by intrauterine administration of autologous PBMC. There have been numerous reports on the positive effects of the intrauterine administration of autologous PBMC on the IVF outcomes (embryo implantation and ongoing pregnancy success). However, there is little data on the direct effect of the PBMC administration on the cell composition of the endometrium. This study will focus on the changes in the endometrial cell populations by PBMC treatment that could lead to IVF outcome improvement. The aim of this project is to analyze the effect of intrauterine administration of autologous PBMC on the endometrial cell populations and on the IVF outcome parameters (implantation and ongoing pregnancy success as IVF outcome variables).
CONDITIONS
Official Title
Effects of Intrauterine Administration of Autologous PBMC on the Endometrial Cells Populations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participating in Assisted Reproduction Treatment
- Presenting altered endometrial immune profile
- Having primary infertility
- Having regular menstrual cycles
- Embryo transfer of euploid embryos
You will not qualify if you...
- Uterine pathologies
- Endometrial Bacterial infections
- Active endometrial inflammation
- Polycystic ovary syndrome
- Presence of auto anti-bodies such as anti-TPO, anti-TG, ACA, APA, ANA, and anti-dsDNA
- Presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S
- Cancer diagnostics
- Positive HIV, HCV or HBV tests
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Nadezhda Women's Health Hospital
Sofia, Sofia, Bulgaria, 1373
Actively Recruiting
2
Medical diagnostic laboratory Imunovita
Sofia, Bulgaria, 1373
Actively Recruiting
Research Team
G
Georgi Stamenov, MD
CONTACT
R
Rumiana Ganeva, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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