Infertility, Female, IVF
Conditions
Keywords
intrauterine PBMC, interferon tau, implantation, clinical pregnancy, live birth rate
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.
Interventions
BIOLOGICALPBMC 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.
Sponsors
Nadezhda Women's Health Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Data analysis will be performed by investigators blind to the patient group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Implantation, % | 4 to 6 weeks post ET procedure | Percentage of patients with positive hCG (human chorionic gonadotropin) test following ET |
| Clinical Pregnancy Rate, % | 6 weeks post ET procedure | Percentage of patients with ultrasound confirmation of gestational sac or heartbeat following ET |
| Live Birth Rate, % | up to 10 months post ET procedure | Percentage of patients with live birth following ET |
Countries
Bulgaria
Contacts
Primary ContactDimitar Parvanov, PhD
Outcome results
None listed