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Aurigene Pharmaceutical Services offers male fertility study services to test compound in rat/mice at three or more different graded dose levels through the intended route of administration.

Our highly skilled team of histotechnicians under the supervision of experienced pathologists perform the male fertility evaluations in rats and mice. The studies are conducted with speed and rigor and the study designs are highly customized to cater to the client product development purposes. Apart from conducting studies, we do offer standalone pathology services as required by the clients for performing standalone histopathology or clinical pathology services.

A separate set of additional animals are kept for vehicle control group for comparison of test item induced changes. The doses are selected based on a dose range finder study or as per the available information on the general toxicity of the test article.

The test item formulations are prepared in suitable vehicle and typically administered for period of at least 11 weeks before mating, during mating and until necropsy. Cohabitation is done (ideally 1:1 ratio) with untreated female animals at least for a period of 14 days. The high dose is expected to produce an evidence of toxicity whereas the mid and low doses are assigned to determine the dose response effects. Vaginal smears from females are made during the cohabitation for determining the stages of estrous and for the presence of sperm. After confirmation of positive mating, females are separated from the male, body weights recorded during gestation. On gestation day 13 to 15, females are euthanized, gross necropsy is conducted and the number of corpora lutea and the location and status of each implant site (live/dead embryo, early/late resorption) are recorded.

In males, after a period of one month of successful mating, necropsy is conducted, reproductive organs such as testis, epidydimides, seminal vesicles, prostrate, etc. are collected and preserved for histopathology. Also, semen parameters such sperm count, sperm motility and sperm viability are evaluated for test item related effects. Serum testosterone levels are also measured. Microscopic examination of testis and epidydimides is carried out for tissue level abnormalities.

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