生殖醫學
Nidacon - ProInsert 精蟲離心管


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Clinical trial
ProInsert , ProGradient and ProBuffer


Background:
The Pro products are a further development of the PureSperm® density gradient for separation and purification of human sperm from patient semen samples.


The new Pro product line is made up of three new products, ProGradientTM, ProBufferTM and ProInsertTM.

ProGradientTM together with ProBufferTM forms the gradient which contains a top layer of protease. The protease activates the sperm enzyme called glyceraldehyde triphosphate dehydrogenase, which in turn increases glycolysis, increases ATP release, and opens calcium channels, all of which augment sperm motility; it may even facilitate the acrosome reaction and increase the fertilising ability.
The protease will also reduce human immunodeficiency virus and hepatitis C, by deactivation of the pathogens with the protease enzyme in the top layer and, furthermore, by utilising the ProInsertTM to remove the pellet from the bottom of the centrifuge tube without recontamination from the overlying layers. The protease can also eliminate anti-sperm antibodies, decreasing sperm agglutination and normalizing semen viscosity.




Aim:
We want to help the HIV positive men and give this group a chance to have healthy children. The technique suggested also proves to increase sperm motility and fertilisation and therefore increase the chance of a successful outcome for all IVF/IUI patients.


Intended use:
ProGradientTM - A silane coated silica solution for the preparation of a density gradient.
ProBufferTM - A protease containing buffer for the dilution of ProGradientTM to form the protease containing top layer of the gradient.
ProInsertTM - A plastic device to facilitate gradient preparation and optimized for retrieving the sperm pellet after a density gradient centrifugation, without recontamination with pathogens.

Inclusion:
The clinical trial will include both IUI and IVF patients.


Study endpoints:
1. Virus levels in semen before and after density gradient preparation
2. Fertilisation rate (ST.IVF and ICSI)
3. Pregnancy rate


Description:
Sperm samples from HIV positive men will be prepared using a density gradient preparation with ProGradientTM, ProBufferTM and ProInsertTM. The amount of virus will be measured in the blood, in the semen before preparation and after preparation.
The preparation will be done using the methodology recommended by Nidacon International AB. All data will be recorded in protocol from Nidacon.
IUI or IVF will be done according to established routines at each clinic but a set protocol from Nidacon will be used for data collection.

 

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