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

Not Applicable

Recruiting

• Conditions: Infertility
• Interventions: Biological: Intrauterine administration of PBMC immunomodulated with IFNt

• Registration Number: NCT05775211
• Lead Sponsor: Nadezhda Women's Health Hospital

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.

Detailed Description

Female patients with no known uterine pathologies and good general health undergoing treatment for unexplained infertility will be identified and invited to participate in the study. Endometrial biopsy will be obtained seven days after luteinizing hormone (LH) surge during a natural cycle. The following month, 5 days after LH surge, peripheral blood mononuclear cells (PBMC) will be isolated from patients' peripheral blood by density gradient (1.077g/ml) centrifugation and suspended in culture medium. The obtained PBMC will be incubated with 500 IU IFNt at 37˚C for 24 hours. This cell suspension will be carefully introduced in the uterine cavity by catheter on day 6 post LH surge. A second biopsy will be obtained the following day (LH+7).

Immunohistochemistry evaluation of endometrial tissue will be performed in terms of quantities and spatial distribution of various cell types.

Study Timeline

• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study Start: 2023-03-13
• Study First Posted: 2023-03-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-03-14
• Study Completion: 2026-04-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endometrial composition before and after autologous modulated PBMC administration	Intrauterine administration of PBMC immunomodulated with IFNt	The endometrial cell composition in terms of cell quantities and spatial distribution will be compared before and after intrauterine administration of immunomodulated PBMC.

Primary Outcome Measures

Name	Time	Method
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	One month prior to and one day following intrauterine administration of cell treatment	Immunohistochemical analysis of endometrial biopsies

Trial Locations

Locations (1)

Nadezhda Women's Health Hospital; 🇧🇬 Sofia, Bulgaria