Effects of Intrauterine Administration of Autologous PBMC Modulated With IFNt on Endometrial Cell Populations

NCT05775211 | Recruiting

• 1 other identifier: 7/28022023
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to investigate the change in endometrial composition during the window of implantation following intrauterine administration of PBMC immunomodulated with IFNt. Patients seeking assisted reproductive therapy will be invited to participate. Two endometrial biopsies will be obtained from each patient during mid-secretory phase of two consecutive menstrual cycles. The first biopsy will be obtained one month before the intervention, and the second one - a day after intrauterine administration of the tested cell treatment which will take place the following month. Immunohistochemistry analysis of the cell composition of the endometrium will be performed.

Conditions

Infertility

Keywords

intrauterine PBMC; interferon tau; endometrium; endometrial cell populations; window of implantation

Outcome Measures

Primary Outcomes (1)

• Change in the numbers of certain endometrial cell populations (immune cells, stem cells, senescent cells) from their levels one month prior to intrauterine administration of immunomodulated PBMC

  Immunohistochemical analysis of endometrial biopsies

  One month prior to and one day following intrauterine administration of cell treatment

Study Arms (1)

Endometrial composition before and after autologous modulated PBMC administration

EXPERIMENTAL

The endometrial cell composition in terms of cell quantities and spatial distribution will be compared before and after intrauterine administration of immunomodulated PBMC.

Biological: Intrauterine administration of PBMC immunomodulated with IFNt

Interventions

Intrauterine administration of PBMC immunomodulated with IFNt BIOLOGICAL

Standard density gradient centrifugation will be performed to obtain autologous PBMC from patients' peripheral blood (9 ml). Isolated cells will be suspended in RPMI 1640 supplemented with 10% HSA (human serum albumin) and incubated in the presence of 500 IU/ml IFNt for 24 h at 37˚C. The cultured cell suspension will be introduced into the uterine cavity via a catheter.

Endometrial composition before and after autologous modulated PBMC administration

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participating in Assisted Reproduction Treatment
• Having primary infertility
• Having regular menstrual cycles
• Having signed informed consent

You may not qualify if:

• Uterine pathologies
• Endometrial bacterial infections
• Active endometrial inflammation
• Polycystic ovary syndrome
• Presence of auto antibodies such as anti-TPO (thyroid peroxidase), anti-TG (thyroglobulin), ACA (anticentromere antibodies), APA (antiphospholipid antibodies), ANA (antinuclear antibodies), and anti-dsDNA
• Presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S
• Oncological condition
• Positive HIV (human immunodeficiency virus), HCV (hepatitis C virus) or HBV (hepatitis B virus) tests

Sponsors & Collaborators

• Nadezhda Women's Health Hospital: lead

Study Sites (1)

Nadezhda Women's Health Hospital

Sofia, Sofia, 1330, Bulgaria

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Dimitar Parvanov, PhD

CONTACT

885944618; dimparvanov@abv.bg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Data analysis will be performed by investigators blind to the biopsy group.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will undergo the same procedures.

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: March 13, 2023
• Primary Completion: March 14, 2026
• Study Completion: April 28, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)