Overview

This trial is active, not recruiting.

Condition healthy
Phase phase 4
Sponsor Conceivex
Start date May 2006
End date May 2007
Trial size 60 participants
Trial identifier NCT00326651, Conception Kit

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model natural history
Time perspective longitudinal

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in January 2007.
Information provided to ClinicalTrials.gov by Conceivex.