Effect of Intrauterine Administration of Autologous PBMC Modulated With IFNt on IVF Outcome

NCT05775198 | Recruiting

• 1 other identifier: 6/28022023
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility, Female; IVF

Keywords

intrauterine PBMC; interferon tau; implantation; clinical pregnancy; live birth rate

Outcome Measures

Primary Outcomes (3)

• Rate of Implantation, %

  Percentage of patients with positive hCG (human chorionic gonadotropin) test following ET

  4 to 6 weeks post ET procedure

• Clinical Pregnancy Rate, %

  Percentage of patients with ultrasound confirmation of gestational sac or heartbeat following ET

  6 weeks post ET procedure

• Live Birth Rate, %

  Percentage of patients with live birth following ET

  up to 10 months post ET procedure

Study Arms (2)

Intrauterine administration of PBMC immunomodulated with IFNt

EXPERIMENTAL

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.

Biological: PBMC immunomodulated with IFNt

Control Group

NO INTERVENTION

Participants will undergo standard embryo transfer procedure with no intervention.

Interventions

PBMC immunomodulated with IFNt BIOLOGICAL

Autologous peripheral blood mononuclear cells (PBMC) isolated using a standard protocol will be cultured in the presence of interferon tau (IFNt) for 24 hours at 37 ˚C and administered in the uterine cavity of patients 1 day prior to embryo transfer.

Intrauterine administration of PBMC immunomodulated with IFNt

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participating in Assisted Reproduction Treatment
• Having primary infertility
• Having regular menstrual cycles
• Scheduled to undergo embryo transfer of euploid embryos only

You may not qualify if:

• Uterine pathologies
• Endometrial bacterial infections
• Active endometrial inflammation
• Polycystic ovary syndrome
• Presence of auto antibodies such as anti-TPO (thyroid peroxidase), anti-TG (thyroglobulin), ACA (anticentromere antibodies), APA (antiphospholipid antibodies), ANA (antinuclear antibodies), and anti-dsDNA
• Presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S
• Oncological condition
• Positive HIV (human immunodeficiency virus), HCV (hepatitis C virus) or HBV (hepatitis B virus) tests

Sponsors & Collaborators

• Nadezhda Women's Health Hospital: lead

Study Sites (1)

Nadezhda Women's Health Hospital

Sofia, Sofia, 1330, Bulgaria

RECRUITING

Related Publications (1)

• Ruseva M, Parvanov D, Ganeva R, Handzhiyska M, Safir J, Nikolova S, Tihomirova T, Metodiev D, Stamenov G, Hadjidekova S. Intrauterine Administration of PBMC Modulated with IFN-tau Before Embryo Transfer Improves Clinical Outcomes of IVF Patients-A Randomized Control Trial. Biomedicines. 2025 Dec 26;14(1):61. doi: 10.3390/biomedicines14010061.

  PMID: 41595597 DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dimitar Parvanov, PhD

CONTACT

885944618; dimparvanov@abv.bg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data analysis will be performed by investigators blind to the patient group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: March 1, 2023
• Primary Completion: March 13, 2026
• Study Completion: April 28, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)