Effect of Intrauterine Administration of Autologous PBMC Modulated With IFNt on IVF Outcome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorNadezhda Women's Health Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Participating in Assisted Reproduction Treatment
Having primary infertility
Having regular menstrual cycles
Scheduled to undergo embryo transfer of euploid embryos only
Disqualifiers
Uterine pathologies
Endometrial bacterial infections
Active endometrial inflammation
Polycystic ovary syndrome
Trial design
Design model
Parallel
Treatments tested in this trial
PBMC immunomodulated with IFNt
Biological/VaccineAutologous 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Intrauterine administration of PBMC immunomodulated with IFNtExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rate of Implantation, %
Percentage of patients with positive hCG (human chorionic gonadotropin) test following ET
Time frame
4 to 6 weeks post ET procedure2
Clinical Pregnancy Rate, %
Percentage of patients with ultrasound confirmation of gestational sac or heartbeat following ET
Time frame
6 weeks post ET procedure3
Live Birth Rate, %
Percentage of patients with live birth following ET
Time frame
up to 10 months post ET procedureLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Nadezhda Women's Health HospitalRecruiting1330, Sofia, Sofia
Bulgaria
BulgariaSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov