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Home Usage of Conception Kit Instructions

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by Conceivex.
Recruitment status was:  Active, not recruiting
Information provided by:
Conceivex Identifier:
First received: May 15, 2006
Last updated: January 31, 2007
Last verified: January 2007
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:

Condition Phase
Phase 4

Study Type: Observational
Study Design: Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
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


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

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 identifier: NCT00326651

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

Publications: Identifier: NCT00326651     History of Changes
Other Study ID Numbers: Conception Kit
Study First Received: May 15, 2006
Last Updated: January 31, 2007

Keywords provided by Conceivex:
trying to conceive
get pregnant
conception kit
conception cap
Women who are actively trying to become pregnant processed this record on May 23, 2017