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

Infertility Clinical Trial

— Ib2C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585012
• Other study ID #: 11-045
• Status: Completed
• Phase: Phase 0
• First received: April 23, 2012
• Last updated: May 4, 2015
• Start date: January 2012
• Est. completion date: March 2012

Study information

• Verified date: May 2015
• Source: Rinovum Women's Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Heterosexual, monogamous couples, of any race or ethnicity, who are sexually active

• 20 - 50 years of age

• Signed Informed Consent

• Past experience with using condoms

• Trying to conceive or using a non-vaginal birth control with which they do not normally use a condom.

Exclusion Criteria:

• Vaginal tract medical interventions with the last three (3) month

• Vaginal prolapse

• Full Hysterectomy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Cervical cap (Focus Touch™ Conception System)
Cervical cap

Locations

Country	Name	City	State
United States	Forbes Regional Hospital	Monroeville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rinovum Women's Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to determine if the Focus Touch™ Conception System Conceptacle is functionally acceptable and meets the user's needs and expectations when used in the home during sexual intercourse as a semen collection device.	Participating couples will be given the Focus Touch™ Conception System Conceptacle. The Conceptacle will be used during sexual intercourse, in the home, to collect semen. The device will be used in accordance with the instructions for use. 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. As a result, this study could take up to 4 days to complete.	4 days	Yes