Clinical trial Recruiting at 2 sites Interventional Ages 20 to 50 Women only

Using patients' own immune cells to improve endometrial health for infertility treatment

Official title: Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) on the Endometrial Cells Populations

Run by Nadezhda Women's Health Hospital · NCT05421364 · Data updated 2026-11-12

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.

More Female Infertility trials

Quick facts

Study typeInterventional
Ages20 Years to 50 Years
SexWomen only
Enrollment300 (estimated)
SponsorNadezhda Women's Health Hospital
Academic / other
Locations2 sites (Sofia, Sofia and 1 other locations)
StatusRecruiting
StartedDecember 9, 2023
Main results expectedJanuary 3, 2026
Study endsDecember 9, 2026
Registry record updatedMay 21, 2025
Trial IDNCT05421364 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include women with primary infertility who are undergoing assisted reproduction treatment and have an altered endometrial immune profile.

Probably not a fit

Patients with uterine pathologies, active endometrial inflammation, or certain autoimmune conditions may not benefit from this treatment.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies have reported positive outcomes with similar approaches, suggesting potential for success in this novel application.

Who can join: the full rules

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 it's running

  • Nadezhda Women's Health Hospital
    Sofia, Sofia, Bulgaria
    Recruiting
  • Medical diagnostic laboratory Imunovita
    Sofia, Bulgaria
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.