Actively Recruiting
Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) on the Endometrial Cells Populations
Led by Nadezhda Women's Health Hospital · Updated on 2025-05-21
300
Participants Needed
2
Research Sites
48 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
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Day 2 after LH peak
Participants receive intrauterine administration of autologous peripheral blood mononuclear cells (PBMC) following blood collection and cell preparation.
1 treatment visit (in-person)
Duration - Up to 8 weeks after embryo transfer
Participants are monitored for changes in endometrial cell populations and pregnancy outcomes after the PBMC administration.
2 follow-up visits (at 2 weeks and 6 to 8 weeks post embryo transfer)
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
R
Rumiana Ganeva, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here