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

Thin Endometrium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05455151
• Other study ID #: ?10-18/11.2018
• Status: Completed
• Phase: Phase 1
• Start date: October 1, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: June 2022
• Source: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: March 1, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Thin Endometrium

Intervention

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

Biological:
• PRP injection
This intervention consisted of injecting platelet-rich plasma (PRP) into the endometrium
• Injection of PRP after conservative therapy
This intervention consisted of conducting conservative therapy with an electrical impulse and then injecting PRP inside the endometrium
• Injection of PRP with endometrial cells
This intervention consisted of injecting endometrial cells suspended in prp

Locations

Country	Name	City	State
Russian Federation	Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare	Sechenov University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 2 month
Primary	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.	1 month
Primary	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.	9 months
Primary	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.	3 month
Primary	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.	3 month