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What will happen after the MicroSort clinical trial ends?

Maureen

Top 25 Contributor

Joined 07-21-2005

Posts 12,600

Site Owner

Maureen

I'll break the ice with a question I see asked a lot!!  What will happen when the clinical trial is complete?  There is a lot of worry about this for women who aren't planning to do MicroSort until a year or two in the future.  Many are worried that MicroSort will "shut down" while the FDA reviews the outcome. 

Ingender.com Site Owner

Mom to Baby BoyBaby Boy and MicroSort/IUI Baby GirlBaby Boy 11-year-old twins!
"Be kind, for everyone you meet is fighting a hard battle." -- Plato

 

Dr. Potter

Daniel Potter

Top 500 Contributor

Laguna Hills, CA

Joined 02-07-2007

Posts 1,301

- IG HRCIG_Gold

Dr. Potter

Hi Maureen,

The FDA has approved an extension of the clinical trial beyond the original number patients allotted.  We expect that this will be adequate to allow uninterrupted access to MicroSort during the FDA review process.  Continued access once the FDA review process is completed, of course, depends on the FDA’s final decision regarding this investigational device.

Dr. Potter

Dr. Daniel Potter, MD, FACOG Huntington Reproductive Center
 
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