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Home Usage of Conception Kit Instructions

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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
Sponsor:
Information provided by:
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.

Condition or disease
Healthy

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 Type : Observational
Enrollment : 60 participants
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
Official Title: Home Usage of Conception Kit Instructions
Study Start Date : May 2006
Study Completion Date : May 2007




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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women who are actively trying to become pregnant

Exclusion Criteria:

  • Women who are contraindicated for a pregnancy

Information from the National Library of Medicine

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


Locations
United States, Michigan
Dr. Charles Barker
Belding, Michigan, United States, 48809
Dr. Dorsey Ligon
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Conceivex
Investigators
Study Director: Michael G La Vean Study Coordinator

Publications of Results:
Other Publications:

ClinicalTrials.gov Identifier: NCT00326651     History of Changes
Other Study ID Numbers: Conception Kit
First Posted: May 17, 2006    Key Record Dates
Last Update Posted: February 1, 2007
Last Verified: January 2007

Keywords provided by Conceivex:
infertility
pregnancy
conception
conceive
conceiving
trying to conceive
get pregnant
conception kit
conception cap
fertility
Women who are actively trying to become pregnant