Actively Recruiting

Phase Not Applicable
Age: 20Years - 50Years
FEMALE
NCT05421364

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

Age: 20Years - 50Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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