Endometrial Immune Profile Changes After Autologous Intrauterine PRP Treatment

April 14, 2026 updated by: Nadezhda Women's Health Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bulgaria
    • Sofia
      • Sofia, Sofia, Bulgaria, 1330
        • Recruiting
        • Nadezhda Women's Health Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
1 month after PRP administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in endometrial thickness (mm) measured by transvaginal ultrasound (TVUS)
Time Frame: 1 month after PRP administration
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
Time Frame: 1 month 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
Time Frame: 1 month 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
Time Frame: Up to 10 weeks after 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
Time Frame: 12 weeks after PRP treatment
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

This is where you will find people and organizations involved with this study.

Sponsor

Nadezhda Women's Health Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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