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Completed

NCT Number: NCT01585012

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

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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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Forbes Regional Hospital

Monroeville, Pennsylvania, 15146, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervical cap (Focus Touch™ Conception System)

Device

Cervical cap

Primary outcomes

  1. 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.

    Time frame: 4 days

    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.

Sponsors and collaborators

Lead sponsor

Rinovum Women's Health, Inc.

Industry

Registry information

Official study title

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

Acronym: Ib2C

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 25, 2012
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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