Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
ID07535190

Prospective Study on Endometrial Immune Profile Changes After Autologous Intrauterine Platelet Rich Plasma (PRP) Treatment

Led by Nadezhda Women's Health Hospital · Updated on 2026-04-17

50

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how autologous intrauterine platelet rich plasma (PRP) treatment affects the endometrial immune profile, endometrial thickness, hormone levels, and IVF outcomes in women undergoing assisted reproduction. The study focuses on women with infertility who have regular menstrual cycles and are receiving embryo transfers. It aims to understand how changes in immune cells within the endometrium may influence IVF success. Participants will receive PRP prepared from their own blood, which will be administered into the uterus by catheter shortly after the LH peak. The PRP administration involves a 1.5 ml dose delivered on day 2 after the LH peak, followed by a short recovery observation before discharge. This treatment is being evaluated for its effect on immune cell populations and hormone levels during the mid-luteal phase. During the study, researchers will measure endometrial immune cells (T cells, NK cells, macrophages) before and one month after PRP treatment. They will also assess endometrial thickness by ultrasound, blood levels of estradiol and progesterone, and track IVF outcomes including biochemical pregnancy up to 10 weeks and clinical pregnancy confirmed by ultrasound at 12 weeks. Participants will be monitored closely following treatment to evaluate these outcomes.

CONDITIONS

Brief Title

Endometrial Immune Profile Changes After Autologous Intrauterine PRP Treatment

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Participating in Assisted Reproduction Treatment
  • Having infertility
  • Having regular menstrual cycles
  • Embryo transfer of euploid embryos
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Single day procedure with recovery

Participants receive autologous intrauterine platelet rich plasma (PRP) administered by catheter on day 2 after LH peak. After the procedure, participants are observed for 30 minutes and discharged home the same day.

1 visit (in-person)

Follow-up

Duration - Up to 12 weeks after treatment

Participants are monitored for changes in endometrial immune profile, endometrial thickness, and hormone levels, as well as for pregnancy outcomes following embryo transfer after PRP administration.

Visits up to 12 weeks for outcome assessments

Trial Site Locations

Total: 1 location

1

Nadezhda Women's Health Hospital

Sofia, Sofia, Bulgaria, 1330

Actively Recruiting

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Research Team

G

Georgi Stamenov, MD

D

Dimitar Parvanov, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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