Female InfertilityNCT05421364
Effects of Intrauterine Administration of Autologous PBMC on the Endometrial Cells Populations
A study testing Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC) in people with Female Infertility, run by Nadezhda Women's Health Hospital at 2 sites in Bulgaria.
Trial summary
The behaviour of the endometrium during its receptive phase is highly dependent on the endometrial cell type composition. Each cell type has its role in the endometrial preparation for the invading embryo. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Female Infertility
- What is being tested?
- Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesBulgaria
- Study dates
- 9 Dec 2023to 9 Dec 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participating in Assisted Reproduction Treatment
- Presenting altered endometrial immune profile
- Having primary infertility
- Having regular menstrual cycles
- Embryo transfer of euploid embryos
Who cannot join
- Uterine pathologies
- Endometrial Bacterial infections
- Active endometrial inflammation
- Polycystic ovary syndrome
- Presence of auto anti-bodies such as anti-TPO, anti-TG, ACA, APA, ANA, and anti-dsDNA
- Presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S
- Cancer diagnostics
- Positive HIV, HCV or HBV tests
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bulgaria2 sites, 2 recruiting
- Recruiting
Nadezhda Women's Health Hospital
Sofia, Sofia, 1373
Georgi Stamenov, MD, +359888269839, g.stamenov@abv.bg
Rumiana Ganeva, MSc, +359898484825, rum.ganeva@gmail.com
- Recruiting
Medical diagnostic laboratory Imunovita
Sofia, 1373
Daniela Baltadzhieva, Professor, +359888823290, baltadjievad@yahoo.com
Petya Boneva, MSc, +359898569702
About this study
Official title: Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) on the Endometrial Cells Populations
The behaviour of the endometrium during its receptive phase is highly dependent on the endometrial cell type composition. Each cell type has its role in the endometrial preparation for the invading embryo. Alteration in the immune cells dialogue could be the main reason for unsuccessful implantation in certain patients. Immune cell homeostasis is often improved by intrauterine administration of autologous PBMC.
There have been numerous reports on the positive effects of the intrauterine administration of autologous PBMC on the IVF outcomes (embryo implantation and ongoing pregnancy success). However, there is little data on the direct effect of the PBMC administration on the cell composition of the endometrium. This study will focus on the changes in the endometrial cell populations by PBMC treatment that could lead to IVF outcome improvement.
The aim of this project is to analyze the effect of intrauterine administration of autologous PBMC on the endometrial cell populations and on the IVF outcome parameters (implantation and ongoing pregnancy success as IVF outcome variables).
- Conditions
- Female Infertility
- Being tested
- Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC)
- Keywords
- Peripheral blood mononuclear cells (PBMC), Female infertility, Endometrium, Endometrial cell populations
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC)Biological
Approximately 9 ml blood from each patient will be collected on the day of the 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. PBMCs (1x106cells/ml) suspended in RPMI 1640 supplemented with 10% HSA will be incubated in the presence of 10 IU/ml hHCG for 48 h. On day 2 after LH peak, fresh PBMCs (1x107 cells) will be also obtained from the same patients, these fresh PBMCs will be immediately combined with the 2-day cultured PBMC and suspended in PBS (2x107 cells/200µl). This cell suspension will be carefully introduced in the uterine cavity by catheter on day 2 after LH peak.
| Study group | Role | What they receive |
|---|---|---|
| Endometrial cell composition | Experimental | The cell composition and their quantities will be compared before and after intrauterine administration of PBMC in the endometrial biopsies. Receives: Biological: Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the numbers of certain ednometrial cell populations (immune cells, stem cells, senescent cells) from their levels one month prior intrauterine PBMC administration
Immunohistochemical analysis
Measured: One month following intrauterine PBMC administration
Change in the percentages of the immune cells in the endometrial stroma from their levels one month prior intrauterine PBMC administration
Flowcytometric analysis
Measured: One month following intrauterine PBMC administration
Change in the distance between the endometrial immune cells, stem cells and senescent cells in the endometrial stroma from their initial distances one month prior intrauterine PBMC administration
Spatial analysis with Visual analysis software
Measured: One month following intrauterine PBMC administration
Secondary outcomes (2)
Embryo implantation rate
Defined as high levels of human chorionic gonadotropin (hCG) in the peripheral blood
Measured: Two weeks following embryo transfer
Clinical pregnancy rate
Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 per number of embryo transferred.
Measured: Six to 8 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start9 Dec 2023
- Primary completion3 Jan 2026 (estimated)
- Study completion9 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female 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
- Both prior to and following PBMC treatment endometrial biopsies will be obtained on day 7 after LH peak. The endometrial samples will be stained immunohistochemically with antibodies against specific endometrial cell types.The endometrial cell composition and the specific cell types quantities will be evaluated by microscopic observation and flowcytometric analysis. The cell composition and their quantities will be compared before and after intrauterine administration of PBMC in the endometrial biopsies.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nadezhda Women's Health Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical diagnostic laboratory ImunoVita
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421364
- Sponsor's protocol ID
- 10/12042022
- Status last verified
- May 2025
- First submitted
- 6 Jun 2022
- 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) on the Endometrial Cells Populations
- ClinicalTrials.gov ID
- NCT05421364
- Acronym / sponsor ID
- 10/12042022
- Conditions
- Female Infertility
- Keywords
- Peripheral blood mononuclear cells (PBMC), Female infertility, Endometrium, Endometrial cell populations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nadezhda Women's Health HospitalUniversity, hospital or other
- Collaborators
- Medical diagnostic laboratory ImunoVita
- Study start
- 9 Dec 2023 (actual)
- Primary completion
- 3 Jan 2026 (estimated)
- Study completion
- 9 Dec 2026 (estimated)
- First posted
- 16 Jun 2022 (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 behaviour of the endometrium during its receptive phase is highly dependent on the endometrial cell type composition. Each cell type has its role in the endometrial preparation for the invading embryo. Alteration in the immune cells dialogue could be the main reason for unsuccessful implantation in certain patients. Immune cell homeostasis is often improved by intrauterine administration of autologous PBMC.
There have been numerous reports on the positive effects of the intrauterine administration of autologous PBMC on the IVF outcomes (embryo implantation and ongoing pregnancy success). However, there is little data on the direct effect of the PBMC administration on the cell composition of the endometrium. This study will focus on the changes in the endometrial cell populations by PBMC treatment that could lead to IVF outcome improvement.
The aim of this project is to analyze the effect of intrauterine administration of autologous PBMC on the endometrial cell populations and on the IVF outcome parameters (implantation and ongoing pregnancy success as IVF outcome variables).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Both prior to and following PBMC treatment endometrial biopsies will be obtained on day 7 after LH peak. The endometrial samples will be stained immunohistochemically with antibodies against specific endometrial cell types.The endometrial cell composition and the specific cell types quantities will be evaluated by microscopic observation and flowcytometric analysis. The cell composition and their quantities will be compared before and after intrauterine administration of PBMC in the endometrial biopsies.
| Arm | Type | Receives |
|---|---|---|
| Endometrial cell composition | Experimental | Biological: Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC)The cell composition and their quantities will be compared before and after intrauterine administration of PBMC in the endometrial biopsies. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participating in Assisted Reproduction Treatment
- Presenting altered endometrial immune profile
- Having primary infertility
- Having regular menstrual cycles
- Embryo transfer of euploid embryos
Key exclusion criteria (8 listed)
- Uterine pathologies
- Endometrial Bacterial infections
- Active endometrial inflammation
- Polycystic ovary syndrome
- Presence of auto anti-bodies such as anti-TPO, anti-TG, ACA, APA, ANA, 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 autologous peripheral blood mononuclear cells (PBMC)Approximately 9 ml blood from each patient will be collected on the day of the 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. PBMCs (1x106cells/ml) suspended in RPMI 1640 supplemented with 10% HSA will be incubated in the presence of 10 IU/ml hHCG for 48 h. On day 2 after LH peak, fresh PBMCs (1x107 cells) will be also obtained from the same patients, these fresh PBMCs will be immediately combined with the 2-day cultured PBMC and suspended in PBS (2x107 cells/200µl). This cell suspension will be carefully introduced in the uterine cavity by catheter on day 2 after LH peak. | Biological | Endometrial cell composition |
Primary outcome
Change in the numbers of certain ednometrial cell populations (immune cells, stem cells, senescent cells) from their levels one month prior intrauterine PBMC administration
Time frame: One month following intrauterine PBMC administration
Immunohistochemical analysis
Change in the percentages of the immune cells in the endometrial stroma from their levels one month prior intrauterine PBMC administration
Time frame: One month following intrauterine PBMC administration
Flowcytometric analysis
Change in the distance between the endometrial immune cells, stem cells and senescent cells in the endometrial stroma from their initial distances one month prior intrauterine PBMC administration
Time frame: One month following intrauterine PBMC administration
Spatial analysis with Visual analysis software
2 secondary outcomes
Embryo implantation rate
Time frame: Two weeks following embryo transfer
Clinical pregnancy rate
Time frame: Six to 8 weeks of gestation
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.
2 sites 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 autologous peripheral blood mononuclear cells (PBMC) in people with Female Infertility, run by Nadezhda Women's Health Hospital at 2 sites 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 5 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 2 sites 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 Georgi Stamenov, MD (+359888269839, g.stamenov@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 ednometrial cell populations (immune cells, stem cells, senescent cells) from their levels one month prior intrauterine PBMC administration (time frame: One month following intrauterine PBMC administration). 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?
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.