Timing is everything for sperm assessment in fertility studies
| Autor: | Sandra De Jonghe, Graham Bailey, Dirk Mariën, Gary Eichenbaum |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Male
0301 basic medicine Time Factors media_common.quotation_subject Fertility Study Guidelines as Topic Fertility 010501 environmental sciences Biology Toxicology 01 natural sciences Dioxanes Rats Sprague-Dawley Abnormal sperm morphology Andrology 03 medical and health sciences Toxicity Tests Animals Mating 0105 earth and related environmental sciences media_common Sulfonamides Dose-Response Relationship Drug Sperm Count urogenital system Spermatozoa Sperm 030104 developmental biology Toxicity Sperm Motility Reproduction Reproductive toxicity |
| Zdroj: | Reproductive Toxicology. 64:141-150 |
| ISSN: | 0890-6238 2648-9112 |
| DOI: | 10.1016/j.reprotox.2016.05.001 |
| Popis: | The fertility study design recommended in the ICH S5(R2) Harmonised Guideline for Detection of Toxicity to Reproduction for Medicinal Products emphasizes the importance of histopathological endpoints next to a pairing assessment in evaluating male fertility. However, in a male rat fertility study with JNJ-26489112, a CNS-active agent, while there were no effects on histological endpoints, mating performance or pregnancy outcomes, sperm assessment was included. The high dose males presented with reversible decreases in epididymal, but not testicular, sperm concentration and motility and an increase in abnormal sperm morphology. In view of the differences in fertility between rats and humans, these types of sperm effects in rats suggest the potential for an impact on human male fertility that would be undetected if not for the sperm assessment. Therefore, the current example suggests that including semenology as a standard endpoint in nonclinical fertility studies may be warranted. |
| Databáze: | OpenAIRE |
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