Conception Kit Clinical Trial 2006
Currently 24% of the participants have become pregnant.
The Conception Kit was the subject of a Clinical Trial authorized by the FDA and conducted under an NSR IDE (Non Signficant Risk Investigational Device Exemption) authorized by the IRBs (Investigational Review Boards) of two major hospitals in Grand Rapids, Michigan.
The purpose of the clinical trial was to determine the following: (1) whether the users could understand the Instructions For Use (IFU), and (2) whether the users could follow the instructions successfully. Successful use meant that the user could understand and follow the instructions including transferring the semen from the semen collector into the conception cap, and properly place the Conception Cap onto the cervix, without spilling the semen that is inside the Conception Cap. The clinical trial also sought to learn whether users could understand and comprehend the warning labels and conditions that the Conception Kit will not overcome.
Each individual component of the Conception Kit already has 510K clearance from the FDA or is exempt under section 21CFR862.1485.
K993953 Conception Cap
K974059 Pregnancy Test Kit (OPK)
K902936 Polyurethane Semen Collector
Ovulation Predictors are exempt under section 21CFR862.1485
The results of the clinical trial were overwhelmingly positive that women can read and follow the instuructions, find their cervix and transfer the semen successfully into the Conception Cap and place it upon their cervix.