NCT05455151

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare · Other Government
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Thin Endometrium

Interventions

Type	Name	Description
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
BIOLOGICAL	Injection of PRP after conservative therapy	This intervention consisted of conducting conservative therapy with an electrical impulse and then injecting PRP inside the endometrium
BIOLOGICAL	Injection of PRP with endometrial cells	This intervention consisted of injecting endometrial cells suspended in prp

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-01-11
• Completion: 2021-03-01
• First posted: 2022-07-13
• Last updated: 2022-07-13

Locations

1 site across 1 country: Russia