NCT01585012

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2012

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

2 months

First QC Date

April 23, 2012

Last Update Submit

May 4, 2015

Conditions

Infertility

Keywords

Cervical cap inseminationCollection condomInstructions for UseSafety during intercourseAcceptability of the cervical cap with condom sheathslipbreakease of conversionadequate sample collection

Outcome Measures

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.

    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

Study Arms (1)

Cervical cap

EXPERIMENTAL

Collection condom with cervical cap inserted

Device: Cervical cap (Focus Touch™ Conception System)

Interventions

Cervical cap (Focus Touch™ Conception System)DEVICE

Cervical cap

Cervical cap

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forbes Regional Hospital

Monroeville, Pennsylvania, 15146, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Contraceptive Devices, Female

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Contraceptive DevicesEquipment and Supplies

Study Officials

  • Michael J Pelekanos, OB-GYN

    Forbes Regional

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2012

First Posted

April 25, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 6, 2015

Record last verified: 2015-05

Locations

US(1)