RecruitingNot ApplicableNCT05775211

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

Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) Modulated With Interferon Tau (IFNt) on Endometrial Cell Populations


Sponsor

Nadezhda Women's Health Hospital

Enrollment

300 participants

Start Date

Mar 13, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Intrauterine administration of PBMC immunomodulated with IFNt for people with infertility. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIntrauterine administration of PBMC immunomodulated with IFNt

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.


Locations(1)

Nadezhda Women's Health Hospital

Sofia, Sofia, Bulgaria

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NCT05775211


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