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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Cervical cap

Collection condom with cervical cap inserted

Group Type EXPERIMENTAL

Cervical cap (Focus Touch™ Conception System)

Intervention Type DEVICE

Cervical cap

Interventions

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Cervical cap (Focus Touch™ Conception System)

Cervical cap

Intervention Type DEVICE

Eligibility Criteria

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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.