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NCT Number: NCT05421364

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

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).

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Key information

Conditions

Female Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nadezhda Women's Health Hospital, Sofia, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC)

Biological

Approximately 9 ml blood from each patient will be collected on the day of the LH peak by peripheral venipuncture using a 21G butterfly catheter affixed via vacutainer to negative pressure receiving tubes (BD vacutainer acid-citrate-dextrose (ACD-A), REF:366645). PBMC will be isolated by density gradient centrifugation in room-temperature centrifuge set to 400 g for 25 min. PBMCs (1x106cells/ml) suspended in RPMI 1640 supplemented with 10% HSA will be incubated in the presence of 10 IU/ml hHCG for 48 h. On day 2 after LH peak, fresh PBMCs (1x107 cells) will be also obtained from the same patients, these fresh PBMCs will be immediately combined with the 2-day cultured PBMC and suspended in PBS (2x107 cells/200µl). This cell suspension will be carefully introduced in the uterine cavity by catheter on day 2 after LH peak.

Primary outcomes

  1. Change in the numbers of certain ednometrial cell populations (immune cells, stem cells, senescent cells) from their levels one month prior intrauterine PBMC administration

    Time frame: One month following intrauterine PBMC administration

    Immunohistochemical analysis

  2. Change in the percentages of the immune cells in the endometrial stroma from their levels one month prior intrauterine PBMC administration

    Time frame: One month following intrauterine PBMC administration

    Flowcytometric analysis

  3. Change in the distance between the endometrial immune cells, stem cells and senescent cells in the endometrial stroma from their initial distances one month prior intrauterine PBMC administration

    Time frame: One month following intrauterine PBMC administration

    Spatial analysis with Visual analysis software

Secondary outcomes

  1. Embryo implantation rate

    Time frame: Two weeks following embryo transfer

    Defined as high levels of human chorionic gonadotropin (hCG) in the peripheral blood

  2. Clinical pregnancy rate

    Time frame: Six to 8 weeks of gestation

    Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 per number of embryo transferred.

Study contacts

Contact information is provided by the study sponsor or research team.

Georgi Stamenov, MD

CONTACT

[email protected]

+359888269839

Rumiana Ganeva, MSc

CONTACT

[email protected]

+359898484825

Sponsors and collaborators

Lead sponsor

Nadezhda Women's Health Hospital

Other

Collaborators

  • Medical diagnostic laboratory ImunoVita

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 16, 2022
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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