Home Usage of Conception Kit Instructions

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00326651

Enrollment

Registered

2006-05-17

Start date

2006-05-31

Completion date

2007-05-31

Last updated

2007-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

Interventions

None listed

Study design

Observational model

NATURAL_HISTORY

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Women who are actively trying to become pregnant

Exclusion criteria

* Women who are contraindicated for a pregnancy

Countries

United States

Outcome results