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Trials / Terminated

TerminatedNCT03387059

Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle

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
Phase
Phase 4
Study type
Interventional
Enrollment
9 (actual)
Sponsor
Merck KGaA, Darmstadt, Germany · Industry
Sex
Female
Age
41 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DEVICEForielleParticipants randomized to receive Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomisation).

Timeline

Start date
2018-01-12
Primary completion
2018-06-12
Completion
2018-06-12
First posted
2017-12-29
Last updated
2019-09-24
Results posted
2019-09-24

Locations

7 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT03387059. Inclusion in this directory is not an endorsement.

Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle (NCT03387059) · Clinical Trials Directory