Human Factors Usability Study of Ib2C Conception System

Completed

Conditions studied: Cervical Cap Insemination

In brief

The purpose of this study is to obtain subjective feedback in a home use environment regarding usability and ease of use of the applicator and conception cap and the instructions for use. Data will be collected and evaluation to determine if the usability requirements of the conception system as determined by the usability specification have been met. The study will not involve sexual intercourse or delivery of any fluids to the cervix. The study will only involve use of the applicator to insert the cervical cap into the vagina, track it to the cervix and prepare and release the cervical cap (with removal string attached) onto the cervix. The conception cap will remain in place for no more than 6 hours.

Key facts

Study ID

NCT01564940

Run by

Rinovum Women's Health, Inc.

People needed

15

Starts

2011-09-01

Expected to finish

2011-09-01

Last updated by the study team

2012-03-28

Who can join

Age: 20 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Female, any ethnicity
• 20 - 45 years of age
• Sexually active
• Signed Informed Consent

You may not qualify if…

• Prior surgery to the cervix or vaginal tract
• Vaginal prolapse
• Cervical cancer
• Hysterectomy
• History of Toxic Shock Syndrome (TSS)

Where it is running

• Forbes Regional Hospital — Monroeville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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