Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-02-22 @ 12:18 PM
Study NCT ID:
NCT05455151
Status:
COMPLETED
Last Update Posted:
2022-07-13
First Post:
2022-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hysteroscopic Injections of Autologous Endometrial Cells and Platelet-rich Plasma in Patients With Thin Endometrium
Sponsor:
Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Organization:
Study Overview
Official Title:
Hysteroscopic Injections of Autologous Endometrial Cells and Platelet-rich Plasma in Patients With Thin Endometrium - a Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: