IVF Patients, Female Infertility
Conditions
Keywords
PRP, endometrium, IVF outcomes
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).
Interventions
BIOLOGICALPlatelet 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.
Sponsors
Nadezhda Women's Health Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative immunohistochemical comparison of endometrial T, NK cells and macrophages (%) before and after intrauterine PRP administration | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in endometrial thickness (mm) measured by transvaginal ultrasound (TVUS) | 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. |
| Quantitative changes in peripheral blood estradiol (E2, pg/mL) levels before and after PRP administration | 1 month after PRP administration | Biochemical analysis of estradiol (E2, pg/mL) in peripheral blood measured by electrochemiluminescence immunoassay. |
| Quantitative changes in peripheral blood progesterone (P4, ng/mL) levels before and after PRP administration | 1 month after PRP administration | Biochemical analysis of progesterone (P4, ng/mL) in peripheral blood measured by electrochemiluminescence |
| 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 | 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. |
| 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 | 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. |
Countries
Bulgaria
Contacts
CONTACTGeorgi Stamenov, MD
CONTACTDimitar Parvanov, PhD
Outcome results
None listed