NCT05775198 Effect of Intrauterine Administration of Autologous PBMC Modulated With IFNt on IVF Outcome
| NCT ID | NCT05775198 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nadezhda Women's Health Hospital |
| Condition | Infertility, Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2026-03-13 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-03-01 with a primary completion date of 2026-03-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05775198 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Infertility, Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05775198 currently recruiting?
Yes, NCT05775198 is actively recruiting participants. Contact the research team at dimparvanov@abv.bg for enrollment information.
Where is the NCT05775198 trial being conducted?
This trial is being conducted at Sofia, Bulgaria.
Who is sponsoring the NCT05775198 clinical trial?
NCT05775198 is sponsored by Nadezhda Women's Health Hospital. The trial plans to enroll 300 participants.