Infertility, FemaleNCT05775198
Effect of Intrauterine Administration of Autologous PBMC Modulated With IFNt on IVF Outcome
A study testing PBMC immunomodulated with IFNt in people with Infertility, Female and IVF, run by Nadezhda Women's Health Hospital at 1 site in Bulgaria.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, IVF
- What is being tested?
- PBMC immunomodulated with IFNt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Mar 2023to 28 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participating in Assisted Reproduction Treatment
- Having primary infertility
- Having regular menstrual cycles
- Scheduled to undergo embryo transfer of euploid embryos only
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bulgaria1 site, 1 recruiting
- Recruiting
Nadezhda Women's Health Hospital
Sofia, Sofia, 1330
Georgi Stamenov, MD, 888269839 ext. 359, g.stamenov@abv.bg
Margarita Ruseva, MSc, 889150267 ext. 359, margarita.ruseva@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Infertility, Female, IVF
- Being tested
- PBMC immunomodulated with IFNt
- Keywords
- intrauterine PBMC, interferon tau, implantation, clinical pregnancy, live birth rate
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBMC immunomodulated with IFNtBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: PBMC immunomodulated with IFNt |
| Control Group | No intervention | Participants will undergo standard embryo transfer procedure with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Implantation, %
Percentage of patients with positive hCG (human chorionic gonadotropin) test following ET
Measured: 4 to 6 weeks post ET procedure
Clinical Pregnancy Rate, %
Percentage of patients with ultrasound confirmation of gestational sac or heartbeat following ET
Measured: 6 weeks post ET procedure
Live Birth Rate, %
Percentage of patients with live birth following ET
Measured: up to 10 months post ET procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Mar 2023
- Primary completion13 Mar 2026 (estimated)
- Study completion28 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nadezhda Women's Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775198
- Sponsor's protocol ID
- 6/28022023
- Status last verified
- May 2025
- First submitted
- 7 Mar 2023
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41595597
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05775198
- Acronym / sponsor ID
- 6/28022023
- Conditions
- Infertility, Female, IVF
- Keywords
- intrauterine PBMC, interferon tau, implantation, clinical pregnancy, live birth rate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nadezhda Women's Health HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 13 Mar 2026 (estimated)
- Study completion
- 28 Apr 2026 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrauterine administration of PBMC immunomodulated with IFNt | Experimental | Biological: PBMC immunomodulated with IFNtApproximately 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. |
| Control Group | No intervention | –Participants will undergo standard embryo transfer procedure with no intervention. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participating in Assisted Reproduction Treatment
- Having primary infertility
- Having regular menstrual cycles
- Scheduled to undergo embryo transfer of euploid embryos only
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBMC immunomodulated with IFNtAutologous 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. | Biological | Intrauterine administration of PBMC immunomodulated with IFNt |
Primary outcome
Rate of Implantation, %
Time frame: 4 to 6 weeks post ET procedure
Percentage of patients with positive hCG (human chorionic gonadotropin) test following ET
Clinical Pregnancy Rate, %
Time frame: 6 weeks post ET procedure
Percentage of patients with ultrasound confirmation of gestational sac or heartbeat following ET
Live Birth Rate, %
Time frame: up to 10 months post ET procedure
Percentage of patients with live birth following ET
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Derived from this study: PubMed 41595597Ruseva 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.
- Individual participant dataSharing planned: No
Related trials for Infertility, Female
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBMC immunomodulated with IFNt in people with Infertility, Female and IVF, run by Nadezhda Women's Health Hospital at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dimitar Parvanov, PhD (885944618 ext. 359, dimparvanov@abv.bg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Implantation, % (time frame: 4 to 6 weeks post ET procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05775198, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.