- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05775211
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dimitar Parvanov, PhD
- Phone Number: 359 885944618
- Email: dimparvanov@abv.bg
Study Locations
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Sofia, Bulgaria, 1330
- Recruiting
- Nadezhda Women's Health Hospital
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Contact:
- Georgi Stamenov, MD
- Phone Number: 359 888269839
- Email: g.stamenov@abv.bg
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Contact:
- Margarita Ruseva, MSc
- Phone Number: 359 889150267
- Email: margarita.ruseva@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: One month prior to and one day following intrauterine administration of cell treatment
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Immunohistochemical analysis of endometrial biopsies
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One month prior to and one day following intrauterine administration of cell treatment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7/28022023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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