Home Usage of Conception Kit Instructions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Conceivex.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Conceivex
ClinicalTrials.gov Identifier:
NCT00326651
First received: May 15, 2006
Last updated: January 31, 2007
Last verified: January 2007
  Purpose

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 Phase
Healthy
Phase 4

Study Type: Observational
Study Design: Observational Model: Natural History
Time Perspective: Longitudinal
Official Title: Home Usage of Conception Kit Instructions

Further study details as provided by Conceivex:

Estimated Enrollment: 60
Study Start Date: May 2006
Estimated Study Completion Date: May 2007
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

  Eligibility

Ages Eligible for Study:   16 Years to 55 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00326651     History of Changes
Other Study ID Numbers: Conception Kit
Study First Received: May 15, 2006
Last Updated: January 31, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 02, 2014