The Stork OTC: Collection, Placement & Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01585012

Infertility

COMPLETED EARLY_PHASE1

Human Factors Usability Study of Ib2C Conception System

NCT01564940

Cervical Cap Insemination

COMPLETED

Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation

NCT04644380

Infertility

COMPLETED NA

Béa Applicator and Béa Cervical Cap Safety and Usability Study

NCT05129553

Safety and Usability

UNKNOWN NA

Test Catheter Pilot Study in Healthy Volunteers

NCT00832078

Healthy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Safety and Usability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The Stork

Device - The Stork - complete kit (Conceptacle and Applicator)

Group Type NO_INTERVENTION

The Stork - Conception Aid

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The Stork - Conception Aid

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

The Stork

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes