Home Usage of Conception Kit Instructions
This trial is active, not recruiting.
|Start date||May 2006|
|End date||May 2007|
|Trial size||60 participants|
|Trial identifier||NCT00326651, Conception Kit|
Patients will use the Conception Kit in their home and fill out a 22 question questionnaire in order to demonstrate their knowledge of the method of usage as described in the instructions and on the website: www.conceptionkit.com.
|Observational model||natural history|
Female participants from 16 years up to 55 years old.
Inclusion Criteria: - Women who are actively trying to become pregnant Exclusion Criteria: - Women who are contraindicated for a pregnancy
|Official title||Home Usage of Conception Kit Instructions|
|Description||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|
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