IVF PatientsNCT07535190
Endometrial Immune Profile Changes After Autologous Intrauterine PRP Treatment
A study testing Platelet rich plasma (PRP) in people with IVF Patients and Female Infertility, run by Nadezhda Women's Health Hospital at 1 site in Bulgaria.
Trial summary
The success rate after treatment by in-vitro fertilisation (IVF) strongly depends on the endometrial receptivity, which in turn is strictly connected to the endometrial immune profile. IVF outcome is largely dependent upon endometrial immune cell ratios and their relationship with one another. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- IVF Patients, Female Infertility
- What is being tested?
- Platelet rich plasma (PRP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBulgaria
- Study dates
- 19 Jan 2026to Jun 2028
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Participating in Assisted Reproduction Treatment
- Having infertility
- Having regular menstrual cycles
- Embryo transfer of euploid embryos
Who cannot join
- Uterine pathologies
- Endometrial Bacterial infections
- Active endometrial inflammation
- Polycystic ovary syndrome
- Cancer diagnostics
- Positive HIV, HCV or HBV tests
- Autoimmune diseases
- Recent immune therapy
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, +359888269839, g.stamenov@abv.bg
Dimitar Parvanov, PhD, +359885944618, dimparvanov@abv.bg
About this study
Official title: Prospective Study on Endometrial Immune Profile Changes After Autologous Intrauterine Platelet Rich Plasma (PRP) Treatment
The success rate after treatment by in-vitro fertilisation (IVF) strongly depends on the endometrial receptivity, which in turn is strictly connected to the endometrial immune profile. IVF outcome is largely dependent upon endometrial immune cell ratios and their relationship with one another.
During the last few years there are several studies and case reports for intrauterine PRP application in patients resulting in a thicker, regenerated endometrium and better immune cell population ratios.
In this project, the investigators aim to analyze the effect of autologous intrauterine PRP administration on the endometrial immune profile, endometrial thickness, selected hormone levels (E2, P4) during the mid-luteal phase and IVF outcomes (biochemical and clinical pregnancy).
- Conditions
- IVF Patients, Female Infertility
- Being tested
- Platelet rich plasma (PRP)
- Keywords
- PRP, endometrium, IVF outcomes
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasma (PRP)Biological
The same day, within 1 hour of sample preparation, the PRP will be carefully introduced in the uterine cavity by catheter on day 2 after LH peak. 1.5 ml of the PRP solution will be administered. After the procedure, the patients will be taken to the recovery room and will be observed for 30 minutes and also be discharged home on the same day.
| Study group | Role | What they receive |
|---|---|---|
| Intrauterine PRP | Experimental | Not described Receives: Biological: Platelet rich plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative immunohistochemical comparison of endometrial T, NK cells and macrophages (%) before and after intrauterine PRP administration
Immunohistochemical analysis of paired endometrial biopsies (before and after PRP administration) and comparison of the quantities of T, NK cells and macrophages.
Measured: 1 month after PRP administration
Secondary outcomes (5)
Changes in endometrial thickness (mm) measured by transvaginal ultrasound (TVUS)
Transvaginal ultrasound measurement of the thickest part of the endometrial stripe performed in the sagittal (longitudinal) plane and comparison to the thickness prior to PRP administration.
Measured: 1 month after PRP administration
Quantitative changes in peripheral blood estradiol (E2, pg/mL) levels before and after PRP administration
Biochemical analysis of estradiol (E2, pg/mL) in peripheral blood measured by electrochemiluminescence immunoassay.
Measured: 1 month after PRP administration
Quantitative changes in peripheral blood progesterone (P4, ng/mL) levels before and after PRP administration
Biochemical analysis of progesterone (P4, ng/mL) in peripheral blood measured by electrochemiluminescence
Measured: 1 month after PRP administration
Number of patients with successful implantation (positive β-hCG blood test) folllowing embryo transfer after intrauterine PRP administration
This outcome measures the number of patients (n) who achieved successful implantation following embryo transfer, as indicated by a positive serum β-hCG blood test, after receiving intrauterine PRP administration. Serum β-hCG levels were assessed using standard electrochemiluminescence immunoassay (ECLIA) two weeks post-transfer to confirm early implantation.
Measured: Up to 10 weeks after PRP administration
Number of patients with clinical pregnancy (ultrasound confirmed gestational sac and/or fetal heartbeat) following embryo transfer after PRP administration
This outcome represents the number of patients (n) who achieved a clinical pregnancy following embryo transfer after receiving intrauterine PRP administration. Clinical pregnancy was defined by the presence of a gestational sac and/or fetal heartbeat confirmed via transvaginal ultrasound, typically performed 6 weeks after the embryo transfer.
Measured: 12 weeks after PRP treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start19 Jan 2026
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVF PatientsStudies 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
- Paired endometrial biopsies (before and after the PRP treatment) will be collected during the mid-luteal phase of two consecutive cycles, stained immunohistochemically in order to visualize different immune cell populations in the endometrium. They will then be digitally analyzed using a specialized software for quantitative and spatial analysis (HALO). The thickness of the endometrium, as well as the E2 and P4 hormone levels and the IVF outcome will also be analyzed and compared.
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT07535190
- Sponsor's protocol ID
- 9/02122025
- Status last verified
- Apr 2026
- First submitted
- 5 Jan 2026
- Last updated
- 17 Apr 2026
- 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Endometrial Immune Profile Changes After Autologous Intrauterine Platelet Rich Plasma (PRP) Treatment
- ClinicalTrials.gov ID
- NCT07535190
- Acronym / sponsor ID
- 9/02122025
- Conditions
- IVF Patients, Female Infertility
- Keywords
- PRP, endometrium, IVF outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nadezhda Women's Health HospitalUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Apr 2026 (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 success rate after treatment by in-vitro fertilisation (IVF) strongly depends on the endometrial receptivity, which in turn is strictly connected to the endometrial immune profile. IVF outcome is largely dependent upon endometrial immune cell ratios and their relationship with one another.
During the last few years there are several studies and case reports for intrauterine PRP application in patients resulting in a thicker, regenerated endometrium and better immune cell population ratios.
In this project, the investigators aim to analyze the effect of autologous intrauterine PRP administration on the endometrial immune profile, endometrial thickness, selected hormone levels (E2, P4) during the mid-luteal phase and IVF outcomes (biochemical and clinical pregnancy).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Paired endometrial biopsies (before and after the PRP treatment) will be collected during the mid-luteal phase of two consecutive cycles, stained immunohistochemically in order to visualize different immune cell populations in the endometrium. They will then be digitally analyzed using a specialized software for quantitative and spatial analysis (HALO). The thickness of the endometrium, as well as the E2 and P4 hormone levels and the IVF outcome will also be analyzed and compared.
| Arm | Type | Receives |
|---|---|---|
| Intrauterine PRP | Experimental | Biological: Platelet rich plasma (PRP) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participating in Assisted Reproduction Treatment
- Having 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
- Cancer diagnostics
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 |
|---|---|---|
| Platelet rich plasma (PRP)The same day, within 1 hour of sample preparation, the PRP will be carefully introduced in the uterine cavity by catheter on day 2 after LH peak. 1.5 ml of the PRP solution will be administered. After the procedure, the patients will be taken to the recovery room and will be observed for 30 minutes and also be discharged home on the same day. | Biological | Intrauterine PRP |
Primary outcome
Quantitative immunohistochemical comparison of endometrial T, NK cells and macrophages (%) before and after intrauterine PRP administration
Time frame: 1 month after PRP administration
Immunohistochemical analysis of paired endometrial biopsies (before and after PRP administration) and comparison of the quantities of T, NK cells and macrophages.
5 secondary outcomes
Changes in endometrial thickness (mm) measured by transvaginal ultrasound (TVUS)
Time frame: 1 month after PRP administration
Quantitative changes in peripheral blood estradiol (E2, pg/mL) levels before and after PRP administration
Time frame: 1 month after PRP administration
Quantitative changes in peripheral blood progesterone (P4, ng/mL) levels before and after PRP administration
Time frame: 1 month after PRP administration
Number of patients with successful implantation (positive β-hCG blood test) folllowing embryo transfer after intrauterine PRP administration
Time frame: Up to 10 weeks after PRP administration
Number of patients with clinical pregnancy (ultrasound confirmed gestational sac and/or fetal heartbeat) following embryo transfer after PRP administration
Time frame: 12 weeks after PRP treatment
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 17 Apr 2026.
- 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 Platelet rich plasma (PRP) in people with IVF Patients and Female 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 17 Apr 2026. 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 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?
Quantitative immunohistochemical comparison of endometrial T, NK cells and macrophages (%) before and after intrauterine PRP administration (time frame: 1 month after PRP administration). 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 17 Apr 2026.