NCT01585012

Usability Study of the Focus Touch™ Conception System: Semen Collection

Phase 2 Human Factors Usability Study of the Focus Touch™ Conception System: Semen Collection

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Rinovum Women's Health, Inc. · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a human factors usability study designed to validated usability by obtaining feedback in a home use environment regarding ease of use of the Focus Touch™ Conception System Conceptacle (when used to collect semen) and the instructions for use. The investigators will collect data to demonstrate that the usability requirements of the conception system as collection device, as determined by Usability Specification: Focus Touch Conception System, ER-000001 have been met. The ability of the device to be used during sexual intercourse without discomfort or injury to the female participant's vaginal/cervical tissues shall also be taken into account. Participating couples will be asked to use the Focus Touch™ Conception System Conceptacle (in condom form), using the Instructions For Use, to collect semen during sexual intercourse in a home use environment. This study will involve sexual intercourse between monogamous, heterosexual couples who are trying to conceive or are on a non-vaginal birth control with which they do not normally use condoms. Participants will be asked to complete the study and the questionnaire within 3 days of receiving the study packet. Contact information shall be collected, but participants will only be contacted if they fail to return the questionnaire within the requested timeframe.

Conditions

• Infertility

Interventions

Type	Name	Description
DEVICE	Cervical cap (Focus Touch™ Conception System)	Cervical cap

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2012-04-25
• Last updated: 2015-05-06

Locations

1 site across 1 country: United States