Using patients' own immune cells to improve endometrial health for infertility treatment
Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) on the Endometrial Cells Populations
This study is testing whether using patients' own immune cells can improve the health of the uterus to help women struggling with infertility have better success with IVF treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | Female |
| Sponsor | Nadezhda Women's Health Hospital Academic / other |
| Locations | 2 sites (Sofia, Sofia and 1 other locations) |
| Trial ID | NCT05421364 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of intrauterine administration of autologous peripheral blood mononuclear cells (PBMC) on the populations of endometrial cells in women experiencing infertility. The research aims to understand how these immune cells can alter the endometrial environment, potentially enhancing embryo implantation success during assisted reproduction treatments. By focusing on the immune profile of the endometrium, the study seeks to provide insights into improving IVF outcomes through cellular composition changes. Participants will receive PBMC treatment to evaluate its impact on their endometrial health.
Who should consider this trial
Good fit: Ideal candidates include women with primary infertility who are undergoing assisted reproduction treatment and have an altered endometrial immune profile.
Not a fit: Patients with uterine pathologies, active endometrial inflammation, or certain autoimmune conditions may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this approach could significantly improve IVF success rates for women with specific infertility issues related to endometrial health.
How similar studies have performed: Previous studies have reported positive outcomes with similar approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participating in Assisted Reproduction Treatment * Presenting altered endometrial immune profile * Having primary infertility * Having regular menstrual cycles * Embryo transfer of euploid embryos Exclusion Criteria: * Uterine pathologies * Endometrial Bacterial infections * Active endometrial inflammation * Polycystic ovary syndrome * Presence of auto anti-bodies such as anti-TPO, anti-TG, ACA, APA, ANA, and anti-dsDNA * Presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S * Cancer diagnostics * Positive HIV, HCV or HBV tests
Where this trial is running
Sofia, Sofia and 1 other locations
- Nadezhda Women's Health Hospital — Sofia, Sofia, Bulgaria (Recruiting)
- Medical diagnostic laboratory Imunovita — Sofia, Bulgaria (Recruiting)
Study contacts
- Study coordinator: Georgi Stamenov, MD
- Email: g.stamenov@abv.bg
- Phone: +359888269839
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.