Microfluidic Sperm Sorting Chips

It has been designed for sorting sperms that have better morphology, physiological and DNA quality from other dead, immature and low quality sperm cells without using techniques that could physically damage viable and healthy sperm cells. The semen sample is usually centrifuged (precipitaion by high-speed rotation) so that the sperm cells can be separated from the fluid before being used for artificial fertilisation. Experts who believe that a damage may occur to the sperm cells during the centrifugation process, stated that the risk (of damage) can be minimized thanks to the microfluidic chips. To sort out the healthy and viable sperm cells from other sperms of poor quality, the semen sample is firstly injected into the inlet canal of the chips (the width of the canal is less than half a millimeter). The healthy and viable sperms then move towards the outlet canal, where they are separated from other poor quality or damaged sperm cells; so that the ratio of healthy and viable sperm cells in the semen sample can be increased from 45% to 98% (This has been scientifically proven).

As per the World Health Organization estimates, 70 million couples worldwide currently suffer from infertility and of all infertility cases, one third is due to «male factor» infertility. Among all the treatment approaches, microinjection, also known as ICSI, was found to be the best solution to male infertility. The pregnancy rates have shown that the most important factor in microinjection technique is the selection of a high quality sperm cell.

The sperm selection parameters for in vitro fertilization (IVF) and ICSI (Intracytoplasmic Sperm Injection) techniques are the motility and the morphology of the sperm cells. However, it has been recently shown that the current techniques are not efficient enough for the selection of sperm cells based on these parameters. Besides, studies have shown that DNA damage is inevitable in sperm sorting techniques based on density (centrifugation). In addition, the flotation technique is based on the swimming-up of motile sperm cells from among the sediment ones. Both of these techniques are inefficient for semen samples with high DNA damage rates.

Microfluidic technologies are used to obtain healthy and viable sperm cells that are necessary for use in in vitro fertilisation for infertility treatment.

Sperm cells move naturally through microchannels to reach the egg. A similar environment to the one in natural fertilisation has been designed on the microchips.

After a better understanding of the microfluidic technology, it has been determined that it also offers a selection mechanism suitable for sperm physiology. The clinical techniques that are currently applied depend on the operative and they can be extremely difficult. The technique that we bring into use is based on a highly efficient microfluidic technology that enables healthy sperm sorting. Thanks to the microchip method, motile sperm cells can be easily sorted out through a miniaturized microfluidic medium.

FERTILE® , FERTILE Plus® and FERTILE Ultimate®  are suitable for use in andrology laboratories, in in vitro fertilisation centers, clinical centers for assisted reproduction and in medical laboratories.

With FERTILE® , FERTILE Plus® and FERTILE Ultimate®    systems, the main aim is: to sort sperm cells having the best DNA quality and being the least exposed to free oxygen radicals, without requiring any pretreatment to the semen sample, thus making this process with less time and stage demanding ; so that the sorted sperms can be efficiently used in IVF (In Vitro Fertilization) and ICSI (Intracytoplasmic Sperm Injection) techniques in order to increase the success rate of in vitro fertilisation treatment.

Our products are being used many centers in Turkey and around the world. Scientific studies are being carried out together with different centers from Turkey, USA, Russia and many European countries ; and the findings are being continuously analysed.

Our products are being manufactured according to the Medical Device Directive from the Turkish Ministry of Health and according to the European Union standards as described in the CE certification. When receiving the CE certification, the medical device produced according to the medical device directive 93/42/EEC is evaluated according to the « Rule 2 » under the title « Non-Invasive devices », as classified in Annex IX.

Besides, the product’s Global Medical Device Classification System Number, also known as the GMDN code: 46553, is evaluated under the title «small equipments used in assisted reproductive treatments.

Scientific Articles

1.  Lab Chip.  2011 Aug 7;11(15):2535-40. doi: 10.1039/c1lc20236g. Epub 2011 Jun 16.

Lensless imaging for simultaneous microfluidic sperm monitoring and sorting.

Zhang X,  Khimji I,  Gurkan UA,  Safaee H,  Catalano PN,  Keles HO,  Kayaalp E,  Demirci U.

http://www.ncbi.nlm.nih.gov/pubmed/21677993

2.  Lab Chip.  2013 Oct 25;9(20):3374-84. doi: 10.1002/smll.201300020. Epub 2013 May 16.

Exhaustion of racing sperm in nature-mimicking microfluidic channels during sorting.

Tasoglu S,  Safaee H,  Zhang X,  Kingsley JL,  Catalano PN,  Gurkan UA,  Nureddin A,  Kayaalp E,  Anchan RM,  Maas RL,  Tüzel E,  Demirci U.

http://www.ncbi.nlm.nih.gov/pubmed/23677651

3.  Adv Healthc Mater. 2014 Oct;3(10):1671-9. doi: 10.1002/adhm.201400058. Epub 2014 Apr 17.

Selection of functional human sperm with higher DNA integrity and fewer reactive oxygen species.

Asghar W,  Velasco V,  Kingsley JL,  Shoukat MS,  Shafiee H,  Anchan RM,  Mutter GL,  Tüzel E,  Demirci U.

http://www.ncbi.nlm.nih.gov/pubmed/24753434

Ürün Patent Bilgileri

FERTILE® MicroFluidic Sperm Sorting Chips (For ICSI)
Patent No: WO/2012/162181
Patent Description: ANALYSIS AND SORTING OF MOTILE CELLS
Link: https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2012162181

FERTILE Plus® MicroFluidic Sperm Sorting Chips (For IUI)
Patent No: WO/2015/077333
Patent Description:SYSTEM AND METHOD FOR SPERM SORTING 
Link: https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2015077333