Clinical trial NCT02038322: The Stork OTC: Collection, Placement & Delivery
Official title: The Stork™ Conception System (OTC) Clinical Trial: Semen Collection, Placement and Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety and Usability
Keywords: OTC Home Use Conception Aid Cervical Cap Insemination
Lead sponsor: Rinovum Women's Health, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-16
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This is a clinical study designed to validate the usability and safety of the over-the-counter (OTC) device by obtaining feedback in a home use environment regarding ease of use of The Stork™ Conception System and the instructions for use. In addition to usability, results for safety, including vaginal

Detailed description: Female participants will undergo a baseline pelvic examination. Participating couples will be given The Stork™ Conception System (OTC), including Instructions for Use, the questionnaire and two ziplock bags. The device will be used in accordance with the instructions for use. Participants will use the Conceptacle as a collection condom during sexual intercourse. Participants will remove the Cervical Cap from the Sheath of the Conceptacle and discard the Sheath. Participants will then load the Cervical Cap into the Applicator for insertion, placement and deployment of the device. Participants will wash the applicator with soap and water and place it in the double zip lock bags. During the time the cervical cap is inserted, normal activity will be recommended with the exception of having intercourse. The female participants will leave the conception cap inserted for a period of time between 4 and 12 hours, return to the investigator's office for examination, remove the Cervical Cap, and undergo a follow up pelvic examination. Participants will be asked to complete the study and the questionnaire within 3 days of receiving the study packet. As a result, this study could take up to 4 days to complete per enrolled couple.

Eligibility criteria: Inclusion Criteria:

* Literacy must be in English (able to understand Informed Consent)
* In general good health
* Heterosexual, monogamous couples, of any race or ethnicity, who are sexually active (as a couple)
* 18 - 50 years of age
* REALM-SF Test Results demonstrate 6th grade literacy or above
* Past experience with using condoms
* Trying to conceive or using a non-vaginal birth control with which they do not normally use a condom.
* Signed Informed Consent

Exclusion Criteria:

* Vaginal prolapsed (female)
* Hysterectomy (female)
* Erectile Dysfunction (male)
* Colposcopy with biopsy surgery within the last three (3) months (female)
* Treatment for dysplasia surgery within the last three (3) months (female)
* Vaginal/cervical surgery within the last three (3) months (female)
* Current Pregnancy (female)
* Unable to read and understand English

Primary outcomes:
measure: Efficacy -Primary endpoint part 1 - Collection
timeFrame: 1-3 days
measure: Efficacy - Primary endpoint part 2 - Placement
timeFrame: 4-12 hrs
measure: Primary endpoint part 3 -Safety
timeFrame: 4-12 hrs
Secondary outcomes:
measure: Secondary Endpoint
timeFrame: up to 3 days
Other outcomes:
Locations:
city: Monroeville
country: United States
facility: Forbes Regional Hospital
state: Pennsylvania
Study officials:
affiliation: Forbes Regional Hospital
name: Michael J Pelekanos, OB-GYN
role: PRINCIPAL_INVESTIGATOR
References: