Investigating the effects of immune cell treatment on endometrial health for infertility
Official title: Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) Modulated With Interferon Tau (IFNt) on Endometrial Cell Populations
Run by Nadezhda Women's Health Hospital · NCT05775211 · Data updated 2026-11-12
This study is testing whether a new immune cell treatment can improve the health of the uterus in women who have unexplained infertility to help them get pregnant.
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 13, 2023 |
| Main results expected | March 14, 2026 |
| Study ends | April 28, 2026 |
| Registry record updated | May 21, 2025 |
| Trial ID | NCT05775211 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women with primary infertility who are undergoing assisted reproductive therapy and have regular menstrual cycles.
✕Probably not a fit
Patients with known uterine pathologies, endometrial infections, or 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 explore how the administration of autologous peripheral blood mononuclear cells (PBMC) modulated with interferon tau (IFNt) affects the composition of the endometrium during the critical window of implantation in women experiencing unexplained infertility. Female participants will undergo two endometrial biopsies: one prior to the treatment and another after the intrauterine administration of the modulated PBMC. The study will analyze changes in endometrial cell populations using immunohistochemistry techniques to assess the potential impact of this treatment on fertility outcomes.
Why it matters
Potential benefit: If successful, this treatment could enhance endometrial receptivity and improve pregnancy rates in women with unexplained infertility.
How similar studies have gone: While the approach of using immunomodulated PBMC is innovative, similar studies have shown promise in enhancing fertility outcomes, suggesting potential for success.
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 * Having signed informed consent 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
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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.