Seminal plasma testis expressed sequence (TEX)-101 as a biomarker for the qualitative assessment of male factor infertility: A case-control study.

OBJECTIVE

The study was conducted to assess the role of seminal plasma Testis Expressed Sequence (TEX)-101 as a biomarker of male infertility.

STUDY

DESIGN

The study was conducted on 180 men (20-50 years) with 90 having abnormal semen reports as cases and 90 with normal reports as controls in a rural tertiary care center in Southern India over two years. After the enrolment of cases and control, semen samples were cryopreserved till the desired sample size was achieved and a biochemical test for TEX-101 was run using Human Testis-expressed Protein 101 ELISA Kit. The results of TEX-101 were compared between cases and controls and correlated with various semen parameters. Statistical analysis was done using SPSS software version 22.0, a p-value < 0.05 was considered statistically significant.

RESULTS

Mean ± SD age of all participants was 29.94 ± 4.91 years. Of 90 cases, 48.9% had asthenospermia, 24.4% oligoasthenospermia, 15.6% oligospermia, 11.1% azoospermia. A statistically significant difference was observed in mean values of seminal plasma TEX-101 between cases (1.45 ± 0.08 ng/mL) and controls (2.26 ± 0.18 ng/mL), p = 0.001. A significant correlation (p = 0.001) was found between seminal TEX-101, semen volume, sperm concentration, progressive motility, and morphology. The area under the Receiver Operating Characteristic curve of TEX-101 between cases and controls was 1.00 (p = 0.001), indicating TEX-101 as a potential biomarker for distinguishing men with abnormal semen parameters from those with normal semen parameters. At a cut-off value of 1.84 ng/mL, seminal plasma TEX-101 had a sensitivity, specificity, and negative and positive predictive values of 100% for male infertility prediction.

CONCLUSION

Seminal TEX-101 is a potential seminal biomarker and can be used in the qualitative assessment of male factor infertility.