Female Infertility Clinical Trial
Official title:
Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) on the Endometrial Cells Populations
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).
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 9, 2026 |
Est. primary completion date | January 3, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 50 Years |
Eligibility | Inclusion Criteria: - Participating in Assisted Reproduction Treatment - Presenting altered endometrial immune profile - Having primary infertility - Having regular menstrual cycles - Embryo transfer of euploid embryos Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Medical diagnostic laboratory Imunovita | Sofia | |
Bulgaria | Nadezhda Women's Health Hospital | Sofia |
Lead Sponsor | Collaborator |
---|---|
Nadezhda Women's Health Hospital | Medical diagnostic laboratory ImunoVita |
Bulgaria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the numbers of certain ednometrial cell populations (immune cells, stem cells, senescent cells) from their levels one month prior intrauterine PBMC administration | Immunohistochemical analysis | One month following intrauterine PBMC administration | |
Primary | Change in the percentages of the immune cells in the endometrial stroma from their levels one month prior intrauterine PBMC administration | Flowcytometric analysis | One month following intrauterine PBMC administration | |
Primary | 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 | Spatial analysis with Visual analysis software | One month following intrauterine PBMC administration | |
Secondary | Embryo implantation rate | Defined as high levels of human chorionic gonadotropin (hCG) in the peripheral blood | Two weeks following embryo transfer | |
Secondary | Clinical pregnancy rate | Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 per number of embryo transferred. | Six to 8 weeks of gestation |
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