The Yourgene® Male Factor Infertility Base and Yourgene® Male Factor Infertility Plus assays use QF-PCR technology and genetic analysers to detect Y-chromosome microdeletions and sex chromosome aneuploidies enabling more effective clinical management of patients.
Statistically, 10-15% of couples experience difficulty in conceiving, with male related factors e.g. low sperm count, thought to be an underlying issue in approximately 50% of cases. Although in the majority of incidences the causes of male infertility are unknown, studies have shown that sex chromosome aneuploidy and microdeletions of specific regions of the Y-chromosome can play a role.
Klinefelter syndrome is the most common sex chromosome aneuploidy associated with male infertility. This syndrome has a live birth incidence of between 1:500 and 1:650 males with the most common cause being an additional copy of the X chromosome (47,XXY karyotype).
Y-chromosome microdeletions are the next most common genetic cause of male infertility, with microdeletions occurring in three regions (AZFa, AZFb, AZFc) detected in up to 7% of oligospermia (also known as oligozoospermia, or low sperm count) and 13% of nonobstructive azoospermia (zero sperm count) cases. These microdeletions occur due to homologous recombination of repetitive sequences in these regions and the exact molecular mechanisms and recombination events underlying these changes have been elucidated. These regions are located at chromosome Yq11 and although the AZFa microdeletion region is distinct, there is a significant degree of overlap between the regions affected by AZFb and AZFc microdeletion.
The European Academy of Andrology (EAA) and European Molecular Genetics Quality Network (EMQN) have published a series of best practice guidelines for Y-chromosome microdeletion testing characterisation and sizing of detected AZF region microdeletions using a separate defined set of markers.
Yourgene offer two CE-marked in vitro diagnostic products (IVD) to detect male infertility. They use Quantitative Fluorescence-Polymerase Chain Reaction (QF-PCR) technology and genetic analysers to detect microdeletions.
Yourgene® Male Factor Infertility Base (formally known as Elucigene® Male Factor Infertility) is also registered with Health Canada/TGA/SFDA.
Yourgene® Male Factor Infertility Base
Our Yourgene® Male Factor Infertility Base assay detects both sex chromosome aneuploidy and Y-chromosome microdeletions in a single tube using QF-PCR. The Male Factor Infertility Kit uses EAA/ EMQN prescribed markers and primers to detect Y-chromosome microdeletions affecting the AZFa, AZFb and AZFc regions in accordance with best practice guidelines.
Yourgene® Male Factor Infertility Plus
The Yourgene® Male Factor Infertility Plus assay is a single tube extension assay, used in conjunction with the Yourgene® Male Factor Infertility Base assay which contains 11 additional markers for characterisation of Y-chromosome microdeletions in line with published guidelines. The Yourgene® Male Factor Infertility Plus assay runs on the same CE genetic analyser platform as the Yourgene® Male Factor Infertility Base assay and uses the same running conditions.
Complete Male Infertility Investigation
We also offer the Yourgene® Cystic Fibrosis Base test to provide a convenient simple solution for male infertility screening for congenital unilateral absence of vas deferens (CUAVD) and congenital bilateral absence of vas deferens (CBAVD) as part of a Male Factor Infertility screening workflow. For more information please visit our Cystic Fibrosis page.
The Yourgene® Male Factor Infertility Base assay of products is available as CE-marked in vitro diagnostic products (IVD) or Research Use Only (RUO) products. Yourgene® Male Factor Infertility Plus is available as a CE-marked in vitro diagnostic product (IVD).
See our Product Menu for further information.
Yourgene® Male Factor Infertility range previously known as Elucigene® Male Factor Infertility range.
The Yourgene® Male Factor Infertility Base assay is easy to set up and involves minimal hands-on time. DNA extracted from whole blood is amplified using QF-PCR and analysed quantitatively on a capillary electrophoresis genetic analyser. Results review and interpretation is simple with no data transfer required.
- Simple set up – one tube per sample
- Rapid – minimum hands on time, just add DNA
- One step protocol – DNA extraction to PCR
- Reduced risk of sample mix-up
- Efficient – fewer consumables, reduced cost
- Validated for use on the ABI 3130 and 3500 Genetic Analysers
- Highly informative – multiplexed 5 dye chemistry
- No post-PCR manipulation
- One capillary per sample
- Cost effective – less instrument consumables
- GeneMarker™ and GeneMapper® software applications
- Simple data review and analysis
- Easy to use intuitive software
- Informative single page report
- No data transfer required
100% specificity and sensitivity
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