Endometrial Immune Profile Changes After Autologous Intrauterine PRP Treatment

NCT07535190 | Recruiting

• 1 other identifier: 9/02122025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

PRP; endometrium; IVF outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes in endometrial thickness (mm) measured by transvaginal ultrasound (TVUS)

  1 month after PRP administration

• Quantitative changes in peripheral blood estradiol (E2, pg/mL) levels before and after PRP administration

  1 month after PRP administration

• Quantitative changes in peripheral blood progesterone (P4, ng/mL) levels before and after PRP administration

  1 month after PRP administration

• Number of patients with successful implantation (positive β-hCG blood test) folllowing embryo transfer after intrauterine PRP administration

  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

  12 weeks after PRP treatment

Study Arms (1)

Intrauterine PRP

EXPERIMENTAL

Biological: Platelet rich plasma (PRP)

Interventions

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.

Intrauterine PRP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participating in Assisted Reproduction Treatment
• Having infertility
• Having regular menstrual cycles
• Embryo transfer of euploid embryos

You may not qualify if:

• Uterine pathologies
• Endometrial Bacterial infections
• Active endometrial inflammation
• Polycystic ovary syndrome
• Cancer diagnostics
• Positive HIV, HCV or HBV tests
• Autoimmune diseases
• Recent immune therapy

Sponsors & Collaborators

• Nadezhda Women's Health Hospital: lead

Study Sites (1)

Nadezhda Women's Health Hospital

Sofia, Sofia, 1330, Bulgaria

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Central Study Contacts

Georgi Stamenov, MD

CONTACT

+359888269839; g.stamenov@abv.bg

Dimitar Parvanov, PhD

CONTACT

+359885944618; dimparvanov@abv.bg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: April 17, 2026
• Study Start: January 19, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)