Effects of Intrauterine Administration of Autologous PBMC Modulated With IFNt on Endometrial Cell Populations
NCT ID: NCT05775211
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2023-03-13
2026-04-28
Brief Summary
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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.
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Detailed Description
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Immunohistochemistry evaluation of endometrial tissue will be performed in terms of quantities and spatial distribution of various cell types.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endometrial composition before and after autologous modulated PBMC administration
The endometrial cell composition in terms of cell quantities and spatial distribution will be compared before and after intrauterine administration of immunomodulated PBMC.
Intrauterine 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.
Interventions
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Intrauterine 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.
Eligibility Criteria
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Inclusion Criteria
* Having primary infertility
* Having regular menstrual cycles
* Having signed informed consent
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
Yes
Sponsors
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Nadezhda Women's Health Hospital
OTHER
Responsible Party
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Locations
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Nadezhda Women's Health Hospital
Sofia, Sofia, Bulgaria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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7/28022023
Identifier Type: -
Identifier Source: org_study_id
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