Clinical trial NCT00326651: Home Usage of Conception Kit Instructions
Official title: Home Usage of Conception Kit Instructions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: infertility
pregnancy
conception
conceive
conceiving
trying to conceive
get pregnant
conception kit
conception cap
fertility
Women who are actively trying to become pregnant
Lead sponsor: Conceivex
Sponsor class: INDUSTRY
First posted: 2006-05-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY
Time perspective: OTHER

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

Eligibility criteria: Inclusion Criteria:

* Women who are actively trying to become pregnant

Exclusion Criteria:

* Women who are contraindicated for a pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Belding
country: United States
facility: Dr. Charles Barker
state: Michigan
city: Grand Rapids
country: United States
facility: Dr. Dorsey Ligon
state: Michigan
Study officials:
affiliation: Study Coordinator
name: Michael G La Vean
role: STUDY_DIRECTOR
References:
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