A Phase 1 interventional study of Conservative therapy and PRP injection in Thin Endometrium, sponsored by Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare. Completed at 1 site in Russian Federation. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-13.
Sponsored by Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare · Phase 1, Interventional, and Prevention
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.
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.
Exclusion Criteria:
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.
Procedure: Conservative therapy
This is Group 2, whose patients received single intraendometrial injections of autologous PRP during proliferative phase (day 6-9) of menstrual cycle.
Biological: PRP injection
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.
Biological: Injection of PRP after conservative therapy
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.
Biological: Injection of PRP with endometrial cells
Conservative therapy to which the patients were subjected was the effect of an electrical impulse
This intervention consisted of injecting platelet-rich plasma (PRP) into the endometrium
This intervention consisted of conducting conservative therapy with an electrical impulse and then injecting PRP inside the endometrium
This intervention consisted of injecting endometrial cells suspended in prp
Change in endometrial thickness after treatment compared with control.
Ultrasonography measurements of endometrial thickness before and after the therapy and compare the thickness. Endometrial thickness measured in mm.
Time frame: Baseline and 2 month
The Doppler-assisted detection of the uterine spiral arteries
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.
Time frame: 1 month
Study of the effect of therapy on the onset of pregnancy
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.
Time frame: 9 months
The content of growth factor in autologous PRP
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.
Time frame: 3 month
Phenotyping of cells isolated from endometrial biopsies
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.
Time frame: 3 month
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare