Effects of Intrauterine Administration of Autologous PBMC Modulated With IFNt on Endometrial Cell Populations
Recruiting now · Not applicable
Conditions studied: Infertility
In brief
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.
Key facts
- Study ID
- NCT05775211
- Run by
- Nadezhda Women's Health Hospital
- People needed
- 300
- Starts
- 2023-03-13
- Expected to finish
- 2026-04-28
- Last updated by the study team
- 2025-05-21
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Participating in Assisted Reproduction Treatment
- Having primary infertility
- Having regular menstrual cycles
- Having signed informed consent
You may not qualify if…
- Uterine pathologies
- Endometrial bacterial infections
- Active endometrial inflammation
- Polycystic ovary syndrome
- Presence of auto antibodies such as anti-TPO (thyroid peroxidase), anti-TG (thyroglobulin), ACA (anticentromere antibodies), APA (antiphospholipid antibodies), ANA (antinuclear antibodies), and anti-dsDNA
- Presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S
- Oncological condition
- Positive HIV (human immunodeficiency virus), HCV (hepatitis C virus) or HBV (hepatitis B virus) tests
Where it is running
- Nadezhda Women's Health Hospital — Sofia, Sofia, Bulgaria (enrolling)
Full record on ClinicalTrials.gov
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