Clinical trial NCT05421364: Effects of Intrauterine Administration of Autologous PBMC on the Endometrial Cells Populations
Official title: Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) on the Endometrial Cells Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Female Infertility
Keywords: Peripheral blood mononuclear cells (PBMC)
Female infertility
Endometrium
Endometrial cell populations
Lead sponsor: Nadezhda Women's Health Hospital
Sponsor class: OTHER
Collaborators: name: Medical diagnostic laboratory ImunoVita
First posted: 2022-06-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Both prior to and following PBMC treatment endometrial biopsies will be obtained on day 7 after LH peak.

The endometrial samples will be stained immunohistochemically with antibodies against specific endometrial cell types.The endometrial cell composition and the specific cell types quantities will be evaluated by microscopic observation and flowcytometric analysis.

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

Brief 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).


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

Primary outcomes:
measure: Change in the numbers of certain ednometrial cell populations (immune cells, stem cells, senescent cells) from their levels one month prior intrauterine PBMC administration
timeFrame: One month following intrauterine PBMC administration
measure: Change in the percentages of the immune cells in the endometrial stroma from their levels one month prior intrauterine PBMC administration
timeFrame: One month following intrauterine PBMC administration
measure: 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
timeFrame: One month following intrauterine PBMC administration
Secondary outcomes:
measure: Embryo implantation rate
timeFrame: Two weeks following embryo transfer
measure: Clinical pregnancy rate
timeFrame: Six to 8 weeks of gestation
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Medical diagnostic laboratory Imunovita
city: Sofia
country: Bulgaria
facility: Nadezhda Women's Health Hospital
Study officials:
References: