Effects of Intrauterine Administration of Autologous PBMC Modulated With IFNt on Endometrial Cell Populations

ConditionInfertility
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorNadezhda Women's Health Hospital

About this trial

The aim of this clinical trial is to investigate the change in endometrial composition during the window of implantation following intrauterine administration of PBMC immunomodulated with IFNt.

Patients seeking assisted reproductive therapy will be invited to participate. Two endometrial biopsies will be obtained from each patient during mid-secretory phase of two consecutive menstrual cycles. The first biopsy will be obtained one month before the intervention, and the second one - a day after intrauterine administration of the tested cell treatment which will take place the following month.

Immunohistochemistry analysis of the cell composition of the endometrium will be performed.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participating in Assisted Reproduction Treatment

Having primary infertility

Having regular menstrual cycles

Having signed informed consent

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 PBMC immunomodulated with IFNt

    Biological/Vaccine

    Standard density gradient centrifugation will be performed to obtain autologous PBMC from patients' peripheral blood (9 ml). Isolated cells will be suspended in RPMI 1640 supplemented with 10% HSA (human serum albumin) and incubated in the presence of 500 IU/ml IFNt for 24 h at 37˚C. The cultured cell suspension will be introduced into the uterine cavity via a catheter.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Endometrial composition before and after autologous modulated PBMC administrationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Immunohistochemical analysis of endometrial biopsies

Time frame
One month prior to and one day following intrauterine administration of cell treatment

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Nadezhda Women's Health HospitalRecruiting1330, Sofia, SofiaBulgariaBulgaria

Sponsors and contacts

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