Intrauterine Administration of PBMC Modulated with IFN-τ Before Embryo Transfer Improves Clinical Outcomes of IVF Patients-A Randomized Control Trial.
Margarita Ruseva, Dimitar Parvanov, Rumiana Ganeva...
https://pubmed.ncbi.nlm.nih.gov/41595597Actively Recruiting
Phase Not Applicable
Age: 18Years - 50Years
FEMALE
Healthy Volunteers
ID05775198
Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) Immunomodulated With Interferon Tau (IFNt) Prior to Embryo Transfer on IVF Outcome
Led by Nadezhda Women's Health Hospital · Updated on 2025-05-21
300
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the effect of specialized immune cells taken from a patient's own blood and treated with interferon tau (IFNt) when placed in the uterus before embryo transfer, on the success of in vitro fertilization (IVF). The trial focuses on improving implantation, pregnancy, and live birth rates in women undergoing IVF, comparing outcomes with a control group that does not receive this cell treatment. The study is randomized and double-blinded to ensure unbiased results. Eligible female patients with no uterine problems and scheduled for embryo transfer will have their peripheral blood mononuclear cells (PBMC) isolated five days after the luteinizing hormone (LH) surge. These cells are treated with IFNt for 24 hours and then introduced into the uterine cavity on day 6 after the LH peak. Embryo transfer is conducted the following day. A control group will undergo the standard embryo transfer without receiving the treated cells. Participants will have blood collected and undergo embryo transfer according to schedule. Researchers will monitor implantation rates at 4 to 6 weeks post-transfer, clinical pregnancy rates at 6 weeks, and live birth rates up to 10 months after embryo transfer. Data analysis will be done without knowledge of group assignment. The total participation duration includes treatment and follow-up assessments to evaluate reproductive outcomes.
CONDITIONS
Brief Title
Effect of Intrauterine Administration of Autologous PBMC Modulated With IFNt on IVF Outcome
Who Can Participate
Age: 18Years - 50Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Participating in Assisted Reproduction Treatment
- Having primary infertility
- Having regular menstrual cycles
- Scheduled to undergo embryo transfer of euploid embryos only
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - 3 days
Participants have blood drawn 5 days after their LH surge to isolate and culture their PBMC with IFNt. The cultured cells are administered into the uterine cavity on day 6 post LH surge, followed by embryo transfer the next day.
3 visits: blood draw visit, intrauterine administration visit, and embryo transfer visit
Follow-up
Duration - Up to 10 months post embryo transfer
Participants are monitored for reproductive outcomes including implantation, clinical pregnancy, and live birth rates after embryo transfer.
Visits approximately at 4 to 6 weeks, 6 weeks, and up to 10 months post embryo transfer
Trial Site Locations
Total: 1 location
1
Nadezhda Women's Health Hospital
Sofia, Sofia, Bulgaria, 1330
Actively Recruiting
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Research Team
D
Dimitar Parvanov, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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