Endometrial Immune Profile Changes After Autologous Intrauterine PRP Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorNadezhda Women's Health Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participating in Assisted Reproduction Treatment
Having infertility
Having regular menstrual cycles
Embryo transfer of euploid embryos
Disqualifiers
Uterine pathologies
Endometrial Bacterial infections
Active endometrial inflammation
Polycystic ovary syndrome
Trial design
Design model
Single group
Treatments tested in this trial
Platelet rich plasma (PRP)
Biological/VaccineThe 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Intrauterine PRPExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
1 month after PRP administrationSecondary outcomes
1
Changes in endometrial thickness (mm) measured by transvaginal ultrasound (TVUS)
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.
Time frame
1 month after PRP administration2
Quantitative changes in peripheral blood estradiol (E2, pg/mL) levels before and after PRP administration
Biochemical analysis of estradiol (E2, pg/mL) in peripheral blood measured by electrochemiluminescence immunoassay.
Time frame
1 month after PRP administration3
Quantitative changes in peripheral blood progesterone (P4, ng/mL) levels before and after PRP administration
Biochemical analysis of progesterone (P4, ng/mL) in peripheral blood measured by electrochemiluminescence
Time frame
1 month after PRP administration4
Number of patients with successful implantation (positive β-hCG blood test) folllowing embryo transfer after intrauterine 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.
Time frame
Up to 10 weeks after PRP administrationLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Nadezhda Women's Health HospitalRecruiting1330, Sofia, Sofia
Bulgaria
BulgariaSponsors and contacts
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Source ClinicalTrials.gov