Clinical trial NCT05775198: Effect of Intrauterine Administration of Autologous PBMC Modulated With IFNt on IVF Outcome
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility, Female
IVF
Keywords: intrauterine PBMC
interferon tau
implantation
clinical pregnancy
live birth rate
Lead sponsor: Nadezhda Women's Health Hospital
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Implantation, %
timeFrame: 4 to 6 weeks post ET procedure
measure: Clinical Pregnancy Rate, %
timeFrame: 6 weeks post ET procedure
measure: Live Birth Rate, %
timeFrame: up to 10 months post ET procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Nadezhda Women's Health Hospital
Study officials:
References: