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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 Touchâ„¢ 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 Touchâ„¢ 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical cap | Experimental | Collection condom with cervical cap inserted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical cap (Focus Touchâ„¢ Conception System) | Device | Cervical cap |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is to determine if the Focus Touchâ„¢ 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 Touchâ„¢ 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Pelekanos, OB-GYN | Forbes Regional | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forbes Regional Hospital | Monroeville | Pennsylvania | 15146 | United States |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D003274 | Contraceptive Devices, Female |
| ID | Term |
|---|---|
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
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