Completed

NCT Number: NCT02038322

The Stork OTC: Collection, Placement & Delivery

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

Completed

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Key information

Conditions

Safety and Usability

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Forbes Regional Hospital

Monroeville, Pennsylvania, 15146, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

The Stork - Conception Aid

Device

Other names: The Stork

Primary outcomes

Efficacy -Primary endpoint part 1 - Collection

Time frame: 1-3 days

The primary endpoint of the study is comprised of 3 parts. It is binary, in the sense that if all of the three parts are "passed" then the endpoint is met for that couple. If any part of the endpoint is not met then the endpoint for that couple is not met. The three parts of the endpoint are:

P1: Participants indicate ability to collect and contain semen using the Conceptacle™.

The examinations will occur 4-12 hours after device insertion.
Efficacy - Primary endpoint part 2 - Placement

Time frame: 4-12 hrs

The primary endpoint of the study is comprised of 3 parts. It is binary, in the sense that if all of the three parts are "passed" then the endpoint is met for that couple. If any part of the endpoint is not met then the endpoint for that couple is not met.

P2: Successful placement of the cervical cap as determined by physical examination.
Primary endpoint part 3 -Safety

Time frame: 4-12 hrs

The primary endpoint of the study is comprised of 3 parts. It is binary, in the sense that if all of the three parts are "passed" then the endpoint is met for that couple. If any part of the endpoint is not met then the endpoint for that couple is not met.

P3: Participants use the device without any evidence of damage to the female participants' genital tract as depicted by physician examination.

Secondary outcomes

Secondary Endpoint

Time frame: up to 3 days

Secondary Objectives: Pass/Fail Answers to the specific questions Male 1-3 and Female 1-4 on the CRF will be compiled descriptively to indicate participant success during the study.

Sponsors and collaborators

Lead sponsor

Rinovum Women's Health, Inc.

Industry

Registry information

Official study title

The Stork™ Conception System (OTC) Clinical Trial: Semen Collection, Placement and Delivery

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jan 16, 2014
Registry last updated: Jan 16, 2014

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.