The Conception Kit® at-home system is an FDA-cleared fertility treatment that can be safely and easily used in the privacy of home.
There is a prescription fertility treatment that is FDA-cleared to treat common infertility issues including low sperm count, low sperm motility, and an acidic vaginal pH environment. It is designed around the proven methodology of cervical cap insemination that has been used by doctors to effectively treat infertility for over fifty years.
Under the 510K FDA classification, the Conception Kit® at-home system is able to claim the class of cervical caps which historically achieve pregnancy rates up to 44%. This is great news for couples who are looking for a safe and effective infertility treatment that can be used at home. To earn the 510K clearance with the FDA, Conceivex Inc. had to demonstrate a variety of factors about the Conception Kit® at-home system including:
- That the Conception Cap®(cervical cap) is substantially equivalent to the predicate devices in terms of safety and effectiveness.
- That patients could use the Conception Kit® and Conception Cap® in the privacy of their home correctly (keep in mind that up to this time period all cervical caps for insemination were used in a physician setting only). 84% of the women found the Conception Kit® at-home system easy to use and 92% of patients were able to understand and follow the instructions correctly.
- That the materials did not change the cervical mucus, or sperm in any way.
- Andrologia 2001 Jul; 33(4):207-13 Evaluation of the effects of a cervical cap device on sperm functional characteristics in vitro. Mahony MC.
Patients who are interested in learning more about the Conception Kit® at-home system are encouraged to speak with their doctor about a prescription. The Conception Kit® can also be used in combination with prescription fertility medications and is an ideal early treatment choice for couples looking for a natural and effective way to enhance their chances of conceiving.
About Conceivex, Inc.
The mission of Conceivex, Inc. is to give women and couples health care products that assist them in reaching their reproductive goals. Currently, one in six women is looking for help becoming pregnant. This is why Conceivex manufactures and distributes the Conception Kit® at-home system, a safe, effective, and reasonably priced method to help women and couples overcome infertility in the privacy of their own home. The Conception Kit® at-home system is FDA cleared and easy to use.
WA 103-2016
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