Endometrial immune profile changes after putting your own PRP into the uterus
Prospective Study on Endometrial Immune Profile Changes After Autologous Intrauterine Platelet Rich Plasma (PRP) Treatment
This test will try whether putting a person's own platelet-rich plasma (PRP) into the uterus improves the uterine immune profile, thickness, hormone levels, and pregnancy rates for people undergoing IVF with euploid embryo transfer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Nadezhda Women's Health Hospital Academic / other |
| Locations | 1 site (Sofia, Sofia) |
| Trial ID | NCT07535190 on ClinicalTrials.gov |
What this trial studies
This interventional single-site study gives autologous intrauterine platelet-rich plasma (PRP) to people undergoing assisted reproduction and euploid embryo transfer, then measures changes in the endometrial immune cell profile and lining thickness. Investigators will also measure mid-luteal estradiol (E2) and progesterone (P4) levels and track IVF outcomes including biochemical and clinical pregnancy. Patients are screened to exclude uterine pathology, active endometrial infection or inflammation, PCOS, autoimmune disease, recent immune therapy, cancer, or positive HIV/HCV/HBV tests. The study is conducted at Nadezhda Women's Health Hospital in Sofia and compares pre- and post-PRP immune and histologic findings alongside pregnancy outcomes.
Who should consider this trial
Good fit: Ideal candidates are people undergoing assisted reproduction with regular menstrual cycles who plan a euploid embryo transfer and do not have uterine pathology or active endometrial infection.
Not a fit: Patients with uterine abnormalities, active endometrial infection or inflammation, PCOS, autoimmune disease, recent immune therapy, cancer, or positive HIV/HCV/HBV tests are excluded and unlikely to benefit from this approach in the study.
Why it matters
Potential benefit: If successful, intrauterine autologous PRP could improve endometrial receptivity, increase lining thickness, and raise biochemical and clinical pregnancy rates after euploid embryo transfer.
How similar studies have performed: Several case reports and small observational studies have reported thicker regenerated endometrium and improved immune cell ratios after intrauterine PRP, but larger randomized data are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participating in Assisted Reproduction Treatment * Having infertility * Having regular menstrual cycles * Embryo transfer of euploid embryos Exclusion Criteria: * Uterine pathologies * Endometrial Bacterial infections * Active endometrial inflammation * Polycystic ovary syndrome * Cancer diagnostics * Positive HIV, HCV or HBV tests * Autoimmune diseases * Recent immune therapy
Where this trial is running
Sofia, Sofia
- Nadezhda Women's Health Hospital — Sofia, Sofia, Bulgaria (Recruiting)
Study contacts
- Study coordinator: Georgi Stamenov, MD
- Email: g.stamenov@abv.bg
- Phone: +359888269839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.