Hysteroscopic Injections of Autologous Endometrial Cells and Platelet-rich Plasma in Patients With Thin Endometrium

Phase 1CompletedNCT05455151

Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare115 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

115

Conditions

Thin Endometrium

Interventions

Conservative therapyPROCEDURE

Conservative therapy to which the patients were subjected was the effect of an electrical impulse

PRP injectionBIOLOGICAL

This intervention consisted of injecting platelet-rich plasma (PRP) into the endometrium

Injection of PRP after conservative therapyBIOLOGICAL

This intervention consisted of conducting conservative therapy with an electrical impulse and then injecting PRP inside the endometrium

Injection of PRP with endometrial cellsBIOLOGICAL

This intervention consisted of injecting endometrial cells suspended in prp

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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.