Usability Study of the Focus Touch™ Conception System: Semen Collection (Ib2C)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rinovum Women's Health, Inc.
ClinicalTrials.gov Identifier:
NCT01585012
First received: April 23, 2012
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Cervical Cap Insemination
Device: Cervical cap (Focus Touch™ Conception System)
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Phase 2 Human Factors Usability Study of the Focus Touch™ Conception System: Semen Collection

Further study details as provided by Rinovum Women's Health, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 30
Study Start Date: January 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervical cap
Collection condom with cervical cap inserted
Device: Cervical cap (Focus Touch™ Conception System)
Cervical cap

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585012

Locations
United States, Pennsylvania
Forbes Regional Hospital
Monroeville, Pennsylvania, United States, 15146
Sponsors and Collaborators
Rinovum Women's Health, Inc.
Investigators
Principal Investigator: Michael J Pelekanos, OB-GYN Forbes Regional
  More Information

No publications provided

Responsible Party: Rinovum Women's Health, Inc.
ClinicalTrials.gov Identifier: NCT01585012     History of Changes
Other Study ID Numbers: 11-045
Study First Received: April 23, 2012
Last Updated: April 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rinovum Women's Health, Inc.:
Cervical cap insemination
Collection condom
Instructions for Use
Safety during intercourse
Acceptability of the cervical cap with condom sheath
slip
break
ease of conversion
adequate sample collection

ClinicalTrials.gov processed this record on September 29, 2014