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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-50
SponsorNadezhda Women's Health Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Participating in Assisted Reproduction Treatment

Presenting altered endometrial immune profile

Having primary infertility

Having regular menstrual cycles

Disqualifiers

Uterine pathologies

Endometrial Bacterial infections

Active endometrial inflammation

Polycystic ovary syndrome

Trial design

Design model

Single group

Treatments tested in this trial

  • Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC)

    Biological/Vaccine

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Endometrial cell compositionExperimental treatment 1 intervention

Trial outcomes

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

Immunohistochemical analysis

Time frame
One month following intrauterine PBMC administration
2

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

Flowcytometric analysis

Time frame
One month following intrauterine PBMC administration
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

Spatial analysis with Visual analysis software

Time frame
One month following intrauterine PBMC administration

Secondary outcomes

1

Embryo implantation rate

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

Time frame
Two weeks following embryo transfer
2

Clinical pregnancy rate

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

Time frame
Six to 8 weeks of gestation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nadezhda Women's Health Hospital

Lead sponsor

Medical diagnostic laboratory ImunoVita

Collaborator