Home Usage of Conception Kit Instructions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00326651|
Recruitment Status : Unknown
Verified January 2007 by Conceivex.
Recruitment status was: Active, not recruiting
First Posted : May 17, 2006
Last Update Posted : February 1, 2007
|Condition or disease||Phase|
Patients will be given a Conception Kit and take the Kit home and read the instructions and if needed consult the website. The patient will then complete a 22 question questionnaire in order to demonstrate their knowledge of the method of use.
All Components have 510K clearance. This study is a validation of the instructions for use (IFU) only.
OPK Class I Device 21CFR 862.1485, Conception Cap K993953, Pregnancy Test Kit K974059, Semen Collection Device K902936 (21CFR 884.5300),
Conception Kit has CE Marked by GMED. (Certificate 2037)
Conceivex is an ISO 13485: 2003 company
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Observational Model:||Natural History|
|Official Title:||Home Usage of Conception Kit Instructions|
|Study Start Date :||May 2006|
|Estimated Study Completion Date :||May 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326651
|United States, Michigan|
|Dr. Charles Barker|
|Belding, Michigan, United States, 48809|
|Dr. Dorsey Ligon|
|Grand Rapids, Michigan, United States, 49503|
|Study Director:||Michael G La Vean||Study Coordinator|