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

NCT01585012 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-05-06

No results posted yet for this study

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

Interventions

DEVICE

Cervical cap (Focus Touch™ Conception System)

Cervical cap

Sponsors & Collaborators

  • Rinovum Women's Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael J Pelekanos, OB-GYN · Forbes Regional

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01585012 on ClinicalTrials.gov