Investigating the effects of immune cell treatment on endometrial health for infertility
Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) Modulated With Interferon Tau (IFNt) on Endometrial Cell Populations
NA · Nadezhda Women's Health Hospital · NCT05775211
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Nadezhda Women's Health Hospital (other) |
| Locations | 1 site (Sofia, Sofia) |
| Trial ID | NCT05775211 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women with primary infertility who are undergoing assisted reproductive therapy and have regular menstrual cycles.
Not a fit: Patients with known uterine pathologies, endometrial infections, or autoimmune conditions may not benefit from this study.
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 performed: While the approach of using immunomodulated PBMC is innovative, similar studies have shown promise in enhancing fertility outcomes, suggesting potential for success.
Eligibility criteria
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 this trial is running
Sofia, Sofia
- Nadezhda Women's Health Hospital — Sofia, Sofia, Bulgaria (RECRUITING)
Study contacts
- Study coordinator: Dimitar Parvanov, PhD
- Email: dimparvanov@abv.bg
- Phone: 885944618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infertility, intrauterine PBMC, interferon tau, endometrium, endometrial cell populations, window of implantation