ICMR to commercialise multiplex PCR-based assay for diagnosis of male infertility

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The Indian Council of Medical Research (ICMR) is seeking potential agencies to commercialise multiplex Polymerase Chain Reaction (PCR) based assay for detection of Y chromosome microdeletions towards diagnosis of male infertility.

Detection of Y chromosome microdeletions is a diagnostic test to establish cause of male infertility.

The diagnostic test is a simple four tube multiplex assay for a unique panel of STS markers that can detect 99.9 per cent of Y chromosome microdeletions that are relevant in the Indian population. The assay detects Y chromosome microdeletions in males that remain undetected by markers currently employed.

As per ICMR officials, assay is ready for technology transfer and the method has also been developed up to laboratory scale and validated accordingly.

Diagnosis of Y chromosome microdeletions is also clinically important for genetic counseling and decision making for assisted reproduction.

This assay is ideal for screening of infertile males choosing to undergo In Vitro Fertilisation (IVF)/Intra Cytoplasmic Sperm Injection (ICSI) to achieve parenthood and infertile males wishing to cryopreserve sperm.

Male infertility is on an increasing trend and one of the major cause is microdeletions of the Y chromosome. In India, 8-10 per cent of infertile males harbour Y chromosome microdeletions.

According to ICMR, developed assay is specific for male samples only, shows no cross reactivity to female DNA. The assay has minimal inter and intra-assay variability. Assay has been optimised to function with DNA isolated from buccal scrapings demonstrating its broad applicability.

Y chromosome infertility is a condition that affects the production of sperm and causes male infertility, which means it is difficult or impossible for affected men to father children.

An affected man’s body may produce no mature sperm cells (azoospermia), fewer than the usual number of sperm cells (oligospermia), or sperm cells that are abnormally shaped or that do not move properly. Men with Y chromosome infertility do not have any other signs or symptoms related to the condition.

Some men with Y chromosome infertility who have mild to moderate oligospermia may eventually father a child naturally. Men with oligospermia may also be helped with assisted reproductive technologies. Most men with Y chromosome infertility have some sperm cells in the testes that can be extracted for this purpose.

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