Home Usage of Conception Kit Instructions

• Conditions: Healthy

• Registration Number: NCT00326651
• Lead Sponsor: Conceivex

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-15
• Study First Submitted QC: 2006-05-15
• Study First Posted: 2006-05-17
• Status Verified: 2007-01
• Last Update Submitted: 2007-01-31
• Last Update Posted: 2007-02-01
• Study Completion: 2007-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Women who are actively trying to become pregnant

Exclusion Criteria

• Women who are contraindicated for a pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Dr. Charles Barker; 🇺🇸 Belding, Michigan, United States

Dr. Dorsey Ligon; 🇺🇸 Grand Rapids, Michigan, United States