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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05421364
Other study ID # 10/12042022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 9, 2023
Est. completion date December 9, 2026

Study information

Verified date March 2024
Source Nadezhda Women's Health Hospital
Contact Georgi Stamenov, MD
Phone +359888269839
Email g.stamenov@abv.bg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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 for 48 h. On day 2 after LH peak, fresh PBMCs (1x107 cells) will be also obtained from the same patients, these fresh PBMCs will be immediately combined with the 2-day cultured PBMC and suspended in PBS (2x107 cells/200µl). This cell suspension will be carefully introduced in the uterine cavity by catheter on day 2 after LH peak.

Locations

Country Name City State
Bulgaria Medical diagnostic laboratory Imunovita Sofia
Bulgaria Nadezhda Women's Health Hospital Sofia

Sponsors (2)

Lead Sponsor Collaborator
Nadezhda Women's Health Hospital Medical diagnostic laboratory ImunoVita

Country where clinical trial is conducted

Bulgaria, 

Outcome

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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