Effects of Intrauterine Administration of Autologous PBMC on the Endometrial Cells Populations

Официальное название

Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) on the Endometrial Cells Populations

Обзор

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).

Вмешательства

• Биопрепарат 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

Первичные конечные точки

• Change in the numbers of certain ednometrial cell populations (immune cells, stem cells, senescent cells) from their levels one month prior intrauterine PBMC administration [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: One month following intrauterine PBMC administration]

Вторичные конечные точки (2)

• Embryo implantation rate [Срок оценки: Two weeks following embryo transfer]
• Clinical pregnancy rate [Срок оценки: Six to 8 weeks of gestation]

Критерии участия

Критерии включения

• Participating in Assisted Reproduction Treatment
• Presenting altered endometrial immune profile
• Having primary infertility
• Having regular menstrual cycles
• Embryo transfer of euploid embryos

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Болгария · 2 центра

• Nadezhda Women's Health Hospital — Sofia
• Medical diagnostic laboratory Imunovita — Sofia

Идентификаторы

NCT: NCT05421364 · 10/12042022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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