Hysteroscopic Injections of Autologous Endometrial Cells and Platelet-rich Plasma in Patients With Thin Endometrium
- Conditions
- Thin Endometrium
- Interventions
- Biological: Injection of PRP with endometrial cellsProcedure: Conservative therapyBiological: Injection of PRP after conservative therapyBiological: PRP injection
- Registration Number
- NCT05455151
- Lead Sponsor
- Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
- Brief Summary
The investigation is devoted to the study of the effect of the introduction of autologous platelet-rich plasma (PRP) on the thickness of the endometrium. It was found that the injection of PRP and endometrial cells resuspended in PRP into the endometrium of patients with thin endometrium leads to an increase in the proliferation of endometrial cells, and as a result, to an increase in its thickness.
- Detailed Description
The study enrolled 115 patients with thin endometrium (\<7 mm at implantation window) and infertility. The cohort was divided into groups based on the treatment regimen.
Group 1 (the control, n=30) underwent conservative therapy. Group 2 (n=42) received intraendometrial injections of autologous PRP instead of the conservative therapy. Group 3 (n=38) received identical injections after conservative therapy. Group 4 (n=5) received injections of the minimally manipulated autologous endometrial cells suspended in autologous PRP.
Injections of PRP and endometrial cells suspended in autologous PRP into basal layer of endometrium facilitate the reconstitution by enhancing cell proliferation and angiogenesis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 115
- Age 18-40 years
- Normal karyotype
- Normal karyotype of the partner
- Regular ovulatory and menstrual cycle
- Endometrium <7 mm thick as measured at implantation window
- Availability of ≥2 vitrified blastocysts of good quality
- History of implantation failure and/or embryo transfer (ET) cancellation due to insufficient endometrial thickness
- Pathospermia in partner
- Use of donor gametes
- Premature ovarian failure
- Internal genital anomalies
- Systemic blood diseases and coagulopathy
- Hemoglobin <100 g/L
- Platelets <100×109/L
- Antiplatelet/anticoagulant therapy recipient status
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Injection of PRP with endometrial cells Injection of PRP with endometrial cells This is Group 4, whose patients received single intraendometrial injections of the minimally manipulated autologous endometrial cells suspended in autologous PRP during proliferative phase (day 6-9) of menstrual cycle. Conservative therapy Conservative therapy This is Group 1, whose patients received electrical impulse therapy using a BTL-4000 Premium G device (BTL Medical Technologies, Czech Republic) starting from day 5-7 of menstrual cycle for 10-12 days daily. Injection of PRP after conservative therapy Injection of PRP after conservative therapy This is Group 3, whose patients received electrical impulse therapy identically with Group 1 during the first menstrual cycle. In the second cycle, the patients received autologous PRP injections identically with Group 2. PRP injection PRP injection This is Group 2, whose patients received single intraendometrial injections of autologous PRP during proliferative phase (day 6-9) of menstrual cycle.
- Primary Outcome Measures
Name Time Method Study of the effect of therapy on the onset of pregnancy 9 months Investigation of the rates of clinical pregnancies and live births in all groups. After therapy, the number of clinical pregnancy and the number of live births were calculated.
Change in endometrial thickness after treatment compared with control. Baseline and 2 month Ultrasonography measurements of endometrial thickness before and after the therapy and compare the thickness. Endometrial thickness measured in mm.
The Doppler-assisted detection of the uterine spiral arteries 1 month The number of identified vessels is counted and the percentage of detection frequency is calculated accordingly, adjusted for the McNemar's binomial test. Compare the rates of visualization of the uterine spiral arteries after therapy in all groups of patients.
The content of growth factor in autologous PRP 3 month Investigation of the content of platelet-derived growth factor-BB (PDGF-BB) and vascular endothelial growth factor (VEGF) in autologous PRP. Relative levels of PDGF-BB and VEGF are normalized to the total protein content.
Phenotyping of cells isolated from endometrial biopsies 3 month Investigation of cellular composition in endometrial biopsy. The percentage of cells positive for markers of mesenzymal stromal cells, epithelial and endothelial cells, lymphocytes is calculated and the determination of the phenotype of cells in endometrial biopsy.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
🇷🇺Moscow, Russian Federation