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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05775198
• Other study ID #: 6/28022023
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: April 28, 2026

Study information

• Verified date: November 2023
• Source: Nadezhda Women's Health Hospital
• Contact: Dimitar Parvanov, PhD
• Phone: 885944618
• Email: dimparvanov[@]abv.bg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Female patients with no known uterine pathologies scheduled to undergo embryo transfer will be identified through patient records and invited to participate in the study. Five days after luteinizing hormone (LH) surge, peripheral blood mononuclear cells (PBMC) will be isolated from these patients' peripheral blood by density gradient centrifugation and suspended in culture medium. The obtained PBMC will be incubated with 500 IU/ml IFNt at 37˚C for 24 hours. This cell suspension will be carefully introduced in the uterine cavity by catheter on day 6 post LH surge. Embryo transfer will be performed the following day. A suitable age-matched control group will be recruited that will undergo embryo transfer but will not be administered immunomodulated PBMC prior to the transfer.

Reproductive outcomes in terms of rate of implantation, rate of clinical pregnancy and live birth rates will be recorded and compared between the two groups.

Data analysis will be performed by investigators blind to the patient group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 28, 2026
• Est. primary completion date: March 13, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Participating in Assisted Reproduction Treatment

• Having primary infertility

• Having regular menstrual cycles

• Scheduled to undergo embryo transfer of euploid embryos only

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• IVF

Intervention

Biological:
• PBMC immunomodulated with IFNt
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.

Locations

Country	Name	City	State
Bulgaria	Nadezhda Women's Health Hospital	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Nadezhda Women's Health Hospital

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Implantation, %	Percentage of patients with positive hCG (human chorionic gonadotropin) test following ET	4 to 6 weeks post ET procedure
Primary	Clinical Pregnancy Rate, %	Percentage of patients with ultrasound confirmation of gestational sac or heartbeat following ET	6 weeks post ET procedure
Primary	Live Birth Rate, %	Percentage of patients with live birth following ET	up to 10 months post ET procedure