Endometrial Immune Profile Changes After Autologous Intrauterine PRP Treatment

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).

Study Overview

• Status: Recruiting
• Conditions: Female Infertility; IVF Patients
• Intervention / Treatment: Biological: Platelet rich plasma (PRP)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Georgi Stamenov, MD; Phone Number: +359888269839; Email: g.stamenov@abv.bg
• Study Contact Backup: Name: Dimitar Parvanov, PhD; Phone Number: +359885944618; Email: dimparvanov@abv.bg

Study Locations

• Bulgaria
  • Sofia
    • Sofia, Sofia, Bulgaria, 1330
      • Recruiting
      • Nadezhda Women's Health Hospital
      • Contact: Georgi Stamenov, MD; Phone Number: +359888269839; Email: g.stamenov@abv.bg
      • Contact: Dimitar Parvanov, PhD; Phone Number: +359885944618; Email: dimparvanov@abv.bg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intrauterine PRP	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month after PRP administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.	12 weeks after PRP treatment

Collaborators and Investigators

• Sponsor: Nadezhda Women's Health Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: endometrium; PRP; IVF outcomes
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: 9/02122025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No