Effects of Intrauterine Administration of Autologous PBMC on the Endometrial Cells Populations
- Conditions
- Female Infertility
- Interventions
- Biological: Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC)
- Registration Number
- NCT05421364
- Lead Sponsor
- Nadezhda Women's Health Hospital
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- Participating in Assisted Reproduction Treatment
- Presenting altered endometrial immune profile
- Having primary infertility
- Having regular menstrual cycles
- Embryo transfer of euploid embryos
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Endometrial cell composition Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC) The cell composition and their quantities will be compared before and after intrauterine administration of PBMC in the endometrial biopsies.
- Primary Outcome Measures
Name Time Method Change in the numbers of certain ednometrial cell populations (immune cells, stem cells, senescent cells) from their levels one month prior intrauterine PBMC administration One month following intrauterine PBMC administration Immunohistochemical analysis
Change in the distance between the endometrial immune cells, stem cells and senescent cells in the endometrial stroma from their initial distances one month prior intrauterine PBMC administration One month following intrauterine PBMC administration Spatial analysis with Visual analysis software
Change in the percentages of the immune cells in the endometrial stroma from their levels one month prior intrauterine PBMC administration One month following intrauterine PBMC administration Flowcytometric analysis
- Secondary Outcome Measures
Name Time Method Embryo implantation rate Two weeks following embryo transfer Defined as high levels of human chorionic gonadotropin (hCG) in the peripheral blood
Clinical pregnancy rate Six to 8 weeks of gestation Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 per number of embryo transferred.
Trial Locations
- Locations (2)
Medical diagnostic laboratory Imunovita
🇧🇬Sofia, Bulgaria
Nadezhda Women's Health Hospital
🇧🇬Sofia, Bulgaria