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Effects of Intrauterine Administration of Autologous PBMC on the Endometrial Cells Populations

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 21, 2025 (before its estimated January 3, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Site details revised at 1 of 2 sitesv6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jan 3, 2024 to Jan 3, 2026
    • Study completion date: Dec 9, 2024 to Dec 9, 2026
    • Site details revised at 2 of 2 sites
    v5
  3. Re-verified, no change to tracked fieldsv4
  4. Primary completion date: Mar 3, 2023 to Jan 3, 2024
    • Start date: Jul 9, 2022 to Dec 9, 2023
    • Study completion date: Apr 9, 2023 to Dec 9, 2024
    v3
  5. Start date: Jun 9, 2022 to Jul 9, 2022v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05421364
Lead Sponsor Nadezhda Women's Health Hospital
Collaborators: Medical diagnostic laboratory ImunoVita
Conditions
(from sponsor)		 Female Infertility
Related terms Infertility, Female
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov