InfertilityNCT05775211
Effects of Intrauterine Administration of Autologous PBMC Modulated With IFNt on Endometrial Cell Populations
A study testing Intrauterine administration of PBMC immunomodulated with IFNt in people with Infertility, run by Nadezhda Women's Health Hospital at 1 site in Bulgaria.
Trial summary
The aim of this clinical trial is to investigate the change in endometrial composition during the window of implantation following intrauterine administration of PBMC immunomodulated with IFNt. Patients seeking assisted reproductive therapy will be invited to participate. 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
- What is being tested?
- Intrauterine administration of 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
- 13 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
- Having signed informed consent
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) Modulated With Interferon Tau (IFNt) on Endometrial Cell Populations
The aim of this clinical trial is to investigate the change in endometrial composition during the window of implantation following intrauterine administration of PBMC immunomodulated with IFNt.
Patients seeking assisted reproductive therapy will be invited to participate. Two endometrial biopsies will be obtained from each patient during mid-secretory phase of two consecutive menstrual cycles. The first biopsy will be obtained one month before the intervention, and the second one - a day after intrauterine administration of the tested cell treatment which will take place the following month.
Immunohistochemistry analysis of the cell composition of the endometrium will be performed.
Read the detailed description
Female patients with no known uterine pathologies and good general health undergoing treatment for unexplained infertility will be identified and invited to participate in the study. Endometrial biopsy will be obtained seven days after luteinizing hormone (LH) surge during a natural cycle. The following month, 5 days after LH surge, peripheral blood mononuclear cells (PBMC) will be isolated from patients' peripheral blood by density gradient (1.077g/ml) centrifugation and suspended in culture medium. The obtained PBMC will be incubated with 500 IU 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. A second biopsy will be obtained the following day (LH+7).
Immunohistochemistry evaluation of endometrial tissue will be performed in terms of quantities and spatial distribution of various cell types.
- Conditions
- Infertility
- Being tested
- Intrauterine administration of PBMC immunomodulated with IFNt
- Keywords
- intrauterine PBMC, interferon tau, endometrium, endometrial cell populations, window of implantation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine administration of PBMC immunomodulated with IFNtBiological
Standard density gradient centrifugation will be performed to obtain autologous PBMC from patients' peripheral blood (9 ml). Isolated cells 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. The cultured cell suspension will be introduced into the uterine cavity via a catheter.
| Study group | Role | What they receive |
|---|---|---|
| Endometrial composition before and after autologous modulated PBMC administration | Experimental | The endometrial cell composition in terms of cell quantities and spatial distribution will be compared before and after intrauterine administration of immunomodulated PBMC. Receives: Biological: Intrauterine administration of PBMC immunomodulated with IFNt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the numbers of certain endometrial cell populations (immune cells, stem cells, senescent cells) from their levels one month prior to intrauterine administration of immunomodulated PBMC
Immunohistochemical analysis of endometrial biopsies
Measured: One month prior to and one day following intrauterine administration of cell treatment
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 start13 Mar 2023
- Primary completion14 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.
- Other trials for InfertilityStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo the same procedures.
- Masking
- None (open label)
- 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
- NCT05775211
- Sponsor's protocol ID
- 7/28022023
- 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
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) Modulated With Interferon Tau (IFNt) on Endometrial Cell Populations
- ClinicalTrials.gov ID
- NCT05775211
- Acronym / sponsor ID
- 7/28022023
- Conditions
- Infertility
- Keywords
- intrauterine PBMC, interferon tau, endometrium, endometrial cell populations, window of implantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nadezhda Women's Health HospitalUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 14 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 aim of this clinical trial is to investigate the change in endometrial composition during the window of implantation following intrauterine administration of PBMC immunomodulated with IFNt.
Patients seeking assisted reproductive therapy will be invited to participate. Two endometrial biopsies will be obtained from each patient during mid-secretory phase of two consecutive menstrual cycles. The first biopsy will be obtained one month before the intervention, and the second one - a day after intrauterine administration of the tested cell treatment which will take place the following month.
Immunohistochemistry analysis of the cell composition of the endometrium will be performed.
Detailed description
Female patients with no known uterine pathologies and good general health undergoing treatment for unexplained infertility will be identified and invited to participate in the study. Endometrial biopsy will be obtained seven days after luteinizing hormone (LH) surge during a natural cycle. The following month, 5 days after LH surge, peripheral blood mononuclear cells (PBMC) will be isolated from patients' peripheral blood by density gradient (1.077g/ml) centrifugation and suspended in culture medium. The obtained PBMC will be incubated with 500 IU 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. A second biopsy will be obtained the following day (LH+7).
Immunohistochemistry evaluation of endometrial tissue will be performed in terms of quantities and spatial distribution of various cell types.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo the same procedures.
| Arm | Type | Receives |
|---|---|---|
| Endometrial composition before and after autologous modulated PBMC administration | Experimental | Biological: Intrauterine administration of PBMC immunomodulated with IFNtThe endometrial cell composition in terms of cell quantities and spatial distribution will be compared before and after intrauterine administration of immunomodulated PBMC. |
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
- Having signed informed consent
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 |
|---|---|---|
| Intrauterine administration of PBMC immunomodulated with IFNtStandard density gradient centrifugation will be performed to obtain autologous PBMC from patients' peripheral blood (9 ml). Isolated cells 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. The cultured cell suspension will be introduced into the uterine cavity via a catheter. | Biological | Endometrial composition before and after autologous modulated PBMC administration |
Primary outcome
Change in the numbers of certain endometrial cell populations (immune cells, stem cells, senescent cells) from their levels one month prior to intrauterine administration of immunomodulated PBMC
Time frame: One month prior to and one day following intrauterine administration of cell treatment
Immunohistochemical analysis of endometrial biopsies
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.
- Individual participant dataSharing planned: No
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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 Intrauterine administration of PBMC immunomodulated with IFNt in people with Infertility, 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?
Change in the numbers of certain endometrial cell populations (immune cells, stem cells, senescent cells) from their levels one month prior to intrauterine administration of immunomodulated PBMC (time frame: One month prior to and one day following intrauterine administration of cell treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.