Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-04 @ 3:51 PM
Study NCT ID:
NCT03387059
Status:
TERMINATED
Last Update Posted:
2019-09-24
First Post:
2017-12-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle
Sponsor:
Merck KGaA, Darmstadt, Germany
Organization:
Study Overview
Official Title:
A Multicentre, Prospective Randomised Controlled, Interventional Clinical Investigation to Assess the Clinical Safety and Performance of Forielle, a Medical Device for Endometrial Washing in Restoring Favorable Endometrial Condition to Implantation After COS During Assisted Reproductive Practice (ENDOMEDE)
Status:
TERMINATED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated early, due to the poor feasibility and sustainability, leading to slow recruitment rate.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENDOMEDE
Brief Summary:
This is a multicenter, prospective randomized controlled, interventional investigation to assess the safety and clinical performance of Forielle, a medical device for endometrial washing, in restoring favorable endometrial condition to implantation after Controlled Ovarian Stimulation (COS) during Assisted Reproductive Technique (ART).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: