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

Nadezhda Women's Health Hospital

Status: Enrolling

Conditions: Female Infertility

Treatments: Biological: Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC)

Study type: Interventional

Funder types: Other

Identifiers

NCT05421364

10/12042022

Details and patient eligibility

About

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).

Enrollment: 300 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Endometrial cell composition

Experimental group

Description:

The cell composition and their quantities will be compared before and after intrauterine administration of PBMC in the endometrial biopsies.

Treatment:

Biological: Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC)