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NCT Number: NCT07535190

Endometrial Immune Profile Changes After Autologous Intrauterine 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).

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Key information

Conditions

IVF Patients Female Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dimitar Parvanov, PhD

CONTACT

[email protected]

+359885944618

Georgi Stamenov, MD

CONTACT

[email protected]

+359888269839

Sponsors and collaborators

Lead sponsor

Nadezhda Women's Health Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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