Effect of Intrauterine Administration of Autologous PBMC Modulated With IFNt on IVF Outcome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PBMC immunomodulated with IFNt.
- Who it may be relevant to
- Registry conditions: Infertility, Female, IVF. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bulgaria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) Immunomodulated With Interferon Tau (IFNt) Prior to Embryo Transfer on IVF Outcome
Overview
The goal of this clinical trial is to test the effect of modulated specialised immune cells isolated from the patients' own blood when administered to the uterus before embryo transfer on the IVF outcome (implantation, pregnancy and live birth rates). To achieve this, blood will be obtained from eligible participants. Target cells will be isolated and incubated with the tested modulator for 24h, and returned to the uterine cavity 1 day prior to embryo transfer. Researchers will compare the reproductive outcome of the tested intervention to that of a control group who will not receive the investigated cell treatment prior to embryo transfer.
Detailed description
Female patients with no known uterine pathologies scheduled to undergo embryo transfer will be identified through patient records and invited to participate in the study. Five days after luteinizing hormone (LH) surge, peripheral blood mononuclear cells (PBMC) will be isolated from these patients' peripheral blood by density gradient centrifugation and suspended in culture medium. The obtained PBMC will be incubated with 500 IU/ml 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. Embryo transfer will be performed the following day. A suitable age-matched control group will be recruited that will undergo embryo transfer but will not be administered immunomodulated PBMC prior to the transfer.
Reproductive outcomes in terms of rate of implantation, rate of clinical pregnancy and live birth rates will be recorded and compared between the two groups.
Data analysis will be performed by investigators blind to the patient group.
Interventions
- Biological PBMC immunomodulated with IFNt
Autologous peripheral blood mononuclear cells (PBMC) isolated using a standard protocol will be cultured in the presence of interferon tau (IFNt) for 24 hours at 37 ˚C and administered in the uterine cavity of patients 1 day prior to embryo transfer.
Primary outcome measures
- Rate of Implantation, % [Time frame: 4 to 6 weeks post ET procedure]
- Clinical Pregnancy Rate, % [Time frame: 6 weeks post ET procedure]
- Live Birth Rate, % [Time frame: up to 10 months post ET procedure]
Eligibility criteria
Inclusion criteria
- Participating in Assisted Reproduction Treatment
- Having primary infertility
- Having regular menstrual cycles
- Scheduled to undergo embryo transfer of euploid embryos only
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Bulgaria · 1 center
- Nadezhda Women's Health Hospital — Sofia
Publications
- Ruseva M, Parvanov D, Ganeva R, Handzhiyska M, Safir J, Nikolova S, Tihomirova T, Metodiev D, Stamenov G, Hadjidekova S. Intrauterine Administration of PBMC Modulated with IFN-tau Before Embryo Transfer Improves Clinical Outcomes of IVF Patients-A Randomized Control Trial. Biomedicines. 2025 Dec 26;14(1):61. doi: 10.3390/biomedicines14010061. PMID 41595597
Identifiers
NCT: NCT05775198 · 6/28022023