Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) Immunomodulated With Interferon Tau (IFNt) Prior to Embryo Transfer on IVF Outcome

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to test the effect of modulated specialised immune cells isolated from the patients' own blood when administered to the uterus before embryo transfer on the IVF outcome (implantation, pregnancy and live birth rates). To achieve this, blood will be obtained from eligible participants. Target cells will be isolated and incubated with the tested modulator for 24h, and returned to the uterine cavity 1 day prior to embryo transfer. Researchers will compare the reproductive outcome of the tested intervention to that of a control group who will not receive the investigated cell treatment prior to embryo transfer.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• Participating in Assisted Reproduction Treatment

• Having primary infertility

• Having regular menstrual cycles

• Scheduled to undergo embryo transfer of euploid embryos only

Locations
Other Locations
Bulgaria
Nadezhda Women's Health Hospital
RECRUITING
Sofia
Contact Information
Primary
Dimitar Parvanov, PhD
dimparvanov@abv.bg
885944618
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2026-04-28
Participants
Target number of participants: 300
Treatments
Experimental: Intrauterine administration of PBMC immunomodulated with IFNt
Approximately 9 ml whole blood will be collected from each patient 5 days post 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. After washing the obtained PBMCs, they 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. On day 6 after LH peak, this cultured cell suspension will be carefully introduced in the uterine cavity by catheter. The following day (LH+7), patients will undergo a standard embryo transfer (ET) procedure.
No_intervention: Control Group
Participants will undergo standard embryo transfer procedure with no intervention.
Related Therapeutic Areas
Sponsors
Leads: Nadezhda Women's Health Hospital

This content was sourced from clinicaltrials.gov