Endometrial Immune Profile Changes After Autologous Intrauterine PRP Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Platelet rich plasma (PRP).
- Who it may be relevant to
- Registry conditions: IVF Patients, Female Infertility. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bulgaria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Study on Endometrial Immune Profile Changes After Autologous Intrauterine Platelet Rich Plasma (PRP) Treatment
Overview
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).
Interventions
- 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.
Primary outcome measures
- Quantitative immunohistochemical comparison of endometrial T, NK cells and macrophages (%) before and after intrauterine PRP administration [Time frame: 1 month after PRP administration]
Secondary outcome measures (5)
- Changes in endometrial thickness (mm) measured by transvaginal ultrasound (TVUS) [Time frame: 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]
- Quantitative changes in peripheral blood progesterone (P4, ng/mL) levels before and after PRP administration [Time frame: 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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Bulgaria · 1 center
- Nadezhda Women's Health Hospital — Sofia
Identifiers
NCT: NCT07535190 · 9/02122025