Effect of Intrauterine Administration of Autologous PBMC Modulated With IFNt on IVF Outcome

Recruiting 300 enrolled Nadezhda Women's Health Hospital

RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start: 2023-03-01
Primary completion: 2026-03-13
Completion: 2026-04-28

Outcome

Mixed primary results

paper In the intervention group, 38.3% of patients achieved implantation, compared to 27.7% in the controls (OR 1.6, 95% CI: 1.0-2.6, p = 0.04). PMID 41595597 ↗

paper Live birth rates were also significantly higher in the IFN-τ-modulated PBMC group (28.7% vs. 17.6%, OR 1.9, 95% CI: 1.1-3.2; p = 0.02). PMID 41595597 ↗

paper While the clinical pregnancy rate was higher, it did not reach statistical significance (34.7% vs. 25.8%, p = 0.08). PMID 41595597 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PBMC immunomodulated with IFNt	Unknown	—	Other