NCT05421364 Effects of Intrauterine Administration of Autologous PBMC on the Endometrial Cells Populations
| NCT ID | NCT05421364 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nadezhda Women's Health Hospital |
| Condition | Female Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-12-09 |
| Primary Completion | 2026-01-03 |
Eligibility & Interventions
Eligibility Fast-Check
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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 2023-12-09 with a primary completion date of 2026-01-03.
⚠ 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 behaviour of the endometrium during its receptive phase is highly dependent on the endometrial cell type composition. Each cell type has its role in the endometrial preparation for the invading embryo. Alteration in the immune cells dialogue could be the main reason for unsuccessful implantation in certain patients. Immune cell homeostasis is often improved by intrauterine administration of autologous PBMC. There have been numerous reports on the positive effects of the intrauterine administration of autologous PBMC on the IVF outcomes (embryo implantation and ongoing pregnancy success). However, there is little data on the direct effect of the PBMC administration on the cell composition of the endometrium. This study will focus on the changes in the endometrial cell populations by PBMC treatment that could lead to IVF outcome improvement. The aim of this project is to analyze the effect of intrauterine administration of autologous PBMC on the endometrial cell populations and on the IVF outcome parameters (implantation and ongoing pregnancy success as IVF outcome variables).
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05421364 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 50 Years, studying Female Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05421364 currently recruiting?
Yes, NCT05421364 is actively recruiting participants. Contact the research team at g.stamenov@abv.bg for enrollment information.
Where is the NCT05421364 trial being conducted?
This trial is being conducted at Sofia, Bulgaria, Sofia, Bulgaria.
Who is sponsoring the NCT05421364 clinical trial?
NCT05421364 is sponsored by Nadezhda Women's Health Hospital. The trial plans to enroll 300 participants.