Using immune cells from patients to improve IVF outcomes
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
Run by Nadezhda Women's Health Hospital · NCT05775198 · Data updated 2026-11-12
This study is testing if using a special type of immune cell from women with infertility can improve the success of in vitro fertilization (IVF) by increasing pregnancy rates.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | Nadezhda Women's Health Hospital Academic / other |
| Locations | 1 site (Sofia, Sofia) |
| Status | Recruiting |
| Started | March 1, 2023 |
| Main results expected | March 13, 2026 |
| Study ends | April 28, 2026 |
| Registry record updated | May 21, 2025 |
| Trial ID | NCT05775198 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women with primary infertility who are scheduled for embryo transfer of euploid embryos and have regular menstrual cycles.
✕Probably not a fit
Patients with uterine pathologies, active infections, or certain autoimmune conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the impact of administering autologous peripheral blood mononuclear cells (PBMC) that have been modulated with interferon tau (IFNt) on the outcomes of in vitro fertilization (IVF). Female patients with primary infertility, scheduled for embryo transfer, will have their blood drawn to isolate PBMC, which will then be treated with IFNt and introduced into the uterine cavity prior to embryo transfer. The study will compare reproductive outcomes, including implantation rates, clinical pregnancy rates, and live birth rates, between those receiving the treatment and a control group not receiving the intervention.
Why it matters
Potential benefit: If successful, this approach could enhance implantation and pregnancy rates for women undergoing IVF.
How similar studies have gone: While the use of immunomodulation in reproductive medicine is being explored, this specific approach with autologous PBMC and IFNt is relatively novel and has not been widely tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Nadezhda Women's Health Hospital
Sofia, Sofia, Bulgaria Recruiting
Study contacts
- Study coordinator: Dimitar Parvanov, PhD
- Email: dimparvanov@abv.bg
- Phone: 885944618
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.