Effects of Intrauterine Administration of Autologous PBMC on the Endometrial Cells Populations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC).
- Who it may be relevant to
- Registry conditions: Female Infertility. Basic parameters: 20 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bulgaria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) on the Endometrial Cells Populations
Overview
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).
Interventions
- Biological Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC)
Approximately 9 ml blood from each patient will be collected on the day of the LH peak by peripheral venipuncture using a 21G butterfly catheter affixed via vacutainer to negative pressure receiving tubes (BD vacutainer acid-citrate-dextrose (ACD-A), REF:366645). PBMC will be isolated by density gradient centrifugation in room-temperature centrifuge set to 400 g for 25 min. PBMCs (1x106cells/ml) suspended in RPMI 1640 supplemented with 10% HSA will be incubated in the presence of 10 IU/ml hHCG f
Primary outcome measures
- Change in the numbers of certain ednometrial cell populations (immune cells, stem cells, senescent cells) from their levels one month prior intrauterine PBMC administration [Time frame: One month following intrauterine PBMC administration]
- Change in the percentages of the immune cells in the endometrial stroma from their levels one month prior intrauterine PBMC administration [Time frame: One month following intrauterine PBMC administration]
- 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 [Time frame: One month following intrauterine PBMC administration]
Secondary outcome measures (2)
- Embryo implantation rate [Time frame: Two weeks following embryo transfer]
- Clinical pregnancy rate [Time frame: Six to 8 weeks of gestation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Bulgaria · 2 centers
- Nadezhda Women's Health Hospital — Sofia
- Medical diagnostic laboratory Imunovita — Sofia
Identifiers
NCT: NCT05421364 · 10/12042022