Pilot study of bovhyaluronidase azoximer in patients with acquired proximal seminal tract obstruction

Gamidov S.I., Popova A.Yu., Shatylko T.V.

V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, Moscow, Russia

Introduction. Acquired proximal seminal tract obstruction may develop as a result of infectious-inflammatory, post-traumatic, or iatrogenic lesions of the epididymis and proximal segments of the vas deferens. In bilateral disease, it leads to obstructive azoospermia. Surgical sperm retrieval and microsurgical reconstruction remain the principal approaches to infertility management; however, conservative treatment targeting the inflammatory and fibrotic component of obstruction is of practical interest.
Aim. To carry out a pilot assessment of the potential effect of different dosage forms of bovhyaluronidase azoximer on semen parameters in patients with acquired proximal seminal tract obstruction.
Material and methods. A total of 80 men with obstructive azoospermia caused by proximal seminal tract obstruction and associated infertility were examined. The patients were divided into two groups of 40 patients each. In the first group, bovhyaluronidase azoximer was administered as rectal suppositories at a dose of 3000 IU; in the second group, it was administered as a lyophilizate for intramuscular injection at a dose of 3000 IU. Follow-up examination and semen analysis were performed once, 95–105 days after the start of therapy. Statistical analysis was primarily descriptive; the proportions of patients with spermatozoa detected in the ejaculate were compared using Fisher’s exact test.
Results. Spermatozoa appeared in the ejaculate in 10 of 80 patients (12.5%). The median sperm concentration was 0.85 million/mL, the median total sperm count was 1.65 million, and the median total motile sperm count was 0.1815 million. In the suppository group, spermatozoa appeared in 6 of 40 patients (15.0%); in the intramuscular injection group, spermatozoa were detected in 4 of 40 patients (10.0%). The between-group difference was not statistically significant (p=0.737).
Discussion. The number of spermatozoa obtained was insufficient for natural conception; however, in selected cases it could be of practical value for cryopreservation and subsequent use in intracytoplasmic sperm injection programs. These results should be considered preliminary because of the pilot design, absence of a control group, and limited number of patients with a positive response.
Conclusion. The obtained data suggest that bovhyaluronidase azoximer may be considered a potentially pathogenetically substantiated component of complex therapy in patients with proximal seminal tract obstruction. Further studies of appropriate methodological quality are required to clarify the clinical significance of these findings.

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About the Authors

Corresponding author: T.V. Shatylko – Ph.D., Urologist, Department of Andrology and Urology, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, Moscow, Russia; e-mail: dialectic.law@gmail.com

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